[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Notices]
[Pages 31976-32002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14453]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-1129]
Medical Devices; Exemptions From Premarket Notification: Class II
Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a list of class II devices that the Agency has determined based on
established factors to no longer require premarket notification to
provide reasonable assurance of safety and effectiveness, subject to
certain limitations. FDA is publishing this notice of that
determination in accordance with procedures established by the 21st
Century Cures Act. This notice represents FDA's final determination
with respect to the list of class II devices proposed in a March 14,
2017, Federal Register document. The exemptions in this notice will
decrease regulatory burdens on the medical device industry and will
eliminate private costs and expenditures required to comply with
certain Federal regulations.
FOR FURTHER INFORMATION CONTACT: Bryce Bennett, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 14, 2017 (82 FR 13609), FDA issued
a notice proposing to exempt a list of class II devices from the
premarket notification requirements under section 510(k) of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)), subject
to certain limitations. This notice was issued in accordance with the
21st Century Cures Act (Pub. L. 114-255), which was signed into law on
December 13, 2016. Section 3054 of that statute amended section 510(m)
of the FD&C Act. As amended, section 510(m)(1)(A) of the FD&C Act
provides that, within 90 days after enactment of the 21st Century Cures
Act and at least once every 5 years thereafter, FDA must publish in the
Federal Register a notice containing a list of each type of class II
device that FDA determines no longer requires a report under section
510(k) of the FD&C Act (generally referred to as a premarket
notification or ``510(k)'') to provide reasonable assurance of safety
and effectiveness. Within 210 days of enactment of the 21st Century
Cures Act, FDA must publish in the Federal Register a list representing
its final determination regarding the list of devices proposed in the
March 14, 2017, notice. Section 510(m)(3) of the FD&C Act provides that
upon the date that this final list is published in the Federal
Register, a 510(k) will no longer be required for the listed devices
and the applicable classification regulation for these devices shall be
deemed amended to incorporate such exemption. Interested persons were
given until May 15, 2017, to comment on the proposed list of class II
devices. After reviewing these comments and considering whether the
proposed list should be modified, FDA is now identifying its final
determination as to which of those devices are now exempt from
premarket notification requirements, subject to certain limitations, as
indicated in tables 1 to 3 of this notice.
In a future action, FDA intends to amend the codified language for
each listed device's classification regulation to reflect this final
determination. Persons with pending 510(k) submissions for devices that
are now exempt from premarket notification, subject to the limitations
on exemptions, should withdraw their submissions.
These exemptions will decrease regulatory burdens on the medical
device industry and will eliminate private costs and expenditures
required to comply with Federal regulation. Specifically, regulated
industry will no longer have to invest time and resources in premarket
notifications, including preparation of documents and data for
submission to FDA, payment of user fees associated with 510(k)
submissions, and responding to questions and requests for additional
information from FDA during 510(k) review.
II. Criteria for Exemption
There are a number of factors FDA may consider to determine whether
a 510(k) is necessary to provide reasonable assurance of the safety and
effectiveness of a class II device. These factors are discussed in the
January 21, 1998, Federal Register notice (63 FR 3142) and subsequently
in the guidance the Agency issued on February 19, 1998, entitled
``Procedures for Class II Device Exemptions from Premarket
Notification, Guidance for Industry and CDRH Staff'' (``Class II 510(k)
Exemption Guidance'') (Ref. 1).
[[Page 31977]]
III. Limitations on Exemptions
FDA believes that the types of class II devices listed in this
notice should be exempt from the premarket notification requirements
found under section 510(k) of the FD&C Act. However, an exemption from
the requirement of premarket notification does not mean that the device
is exempt from any other statutory or regulatory requirements, unless
such exemption is explicitly provided by order or regulation. FDA's
determination that premarket notification is unnecessary to provide a
reasonable assurance of safety and effectiveness for devices listed in
this document is based, in part, on the assurance of safety and
effectiveness that other regulatory controls, such as current good
manufacturing practice requirements, provide.
In addition to being subject to the general limitations to the
exemptions found in Title 21 of the Code of Federal Regulations (CFR)
sections 862.9 to 892.9 (Sec. Sec. 862.9 to 892.9), when Agency
assessment determines that the factors laid out in the Class II 510(k)
Exemption Guidance (Ref. 1) do not weigh in favor of exemption for all
devices in a particular group, FDA may partially limit the exemption
from premarket notification requirements to specific devices within a
listed device type. In such situations where a partial exemption
limitation has been identified, FDA has determined that premarket
notification is necessary to provide a reasonable assurance of safety
and effectiveness for these devices. Partial exemption limitations can
be found in table 2 of this notice. FDA has assigned new product codes
to the device types that are now exempt subject to the partial
limitations in order to ensure that these devices can be separated from
devices that do not fall within the partial exemption limitation under
the existing product code (i.e., exempt and non-exempt devices within a
device type will have distinct product codes). If table 2 indicates
that a partial exemption limitation does apply to a device, then
affected device manufacturers should review their registration and
listing information to assess if they should list their device using
the original classification product code, which requires premarket
notification, or the new classification product code for the subset of
that device type that is now 510(k) exempt (subject to the general
limitations to the exemptions found in Sec. Sec. 862.9 to 892.9). In
table 2, for example, FDA is listing the exemption of the tympanometer
but limits the exemption to such devices that are in compliance with
FDA-recognized consensus standard ANSI S3.39. Tympanometers that comply
with this partial exemption limitation and the corresponding general
limitations in Sec. 874.9 are now exempt from the 510(k) requirements
and should be identified under new product code ``PTP'' in subsequent
registration and listing submissions. However, tympanometers not in
compliance with each of these exemption limitations remain subject to
the 510(k) requirements and will retain product code ``NAS.'' We
recommend that device manufacturers document in their records any
changes in the product code of their device with appropriate
justification.
IV. List of Class II Devices
In table 1, FDA is identifying the following list of class II
devices that no longer require premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec. Sec. 862.9 to 892.9:
Table 1--Class II Devices
------------------------------------------------------------------------
21 CFR section Device type Product code
------------------------------------------------------------------------
862.1020.................. Acid Phosphatase, CJN
Nitrophenylphosphate.
862.1020.................. Acid Phosphatase, Thymol CJR
Blue Monophosphate.
862.1020.................. Acid Phosphatase, CJX
Disodium Phenylphosphate.
862.1020.................. Acid Phosphatase, CKB
Naphthyl Phosphate.
862.1020.................. Acid Phosphatase, CKE
Thymolphthale
Inmonophosphate.
862.1020.................. Acid Phosphatase, Beta CKH
Glycerophosphate.
862.1020.................. Acid Phosphatase JFH
(Prostatic), Tartrate
Inhibited.
862.1090.................. Radioassay, Angiotensin KQN
Converting Enzyme.
862.1100.................. Vanillin Pyruvate, AST/ CIF
SGOT.
862.1100.................. Diazo, AST/SGOT.......... CIQ
862.1100.................. Hydrazone Colorimetry, CIS
AST/SGOT.
862.1100.................. NADH Oxidation/NAD CIT
Reduction, AST/SGOT.
862.1150.................. Calibrator, Primary...... JIS
862.1150.................. Calibrator, Secondary.... JIT
862.1150.................. Calibrator, Surrogate.... JIW
862.1150.................. Calibrator, Multi-Analyte JIX
Mixture.
862.1345.................. Drink, Glucose Tolerance. MRV
862.1350.................. Continuous Glucose PJT
Monitor Secondary
Display.
862.1445.................. Chromatographic CEX
Separation, Lactate
Dehydrogenase Isoenzymes.
862.1445.................. Electrophoretic, Lactate CFE
Dehydrogenase Isoenzymes.
862.1445.................. Differential Rate Kinetic JGF
Method, Lactate
Dehydrogenase Isoenzymes.
862.1509.................. System, Test, Urinary LPT
Methylmalonic Acid.
862.1685.................. Radioimmunoassay, CEE
Thyroxine-Binding
Globulin.
862.1700.................. Radioimmunoassay, Total CDX
Thyroxine.
862.1700.................. Enzyme Immunoassay, Non- KLI
Radiolabeled, Total
Thyroxine.
862.2265.................. High Throughput DNA PFF
Sequence Analyzer.
862.2570.................. Instrumentation For NSU
Clinical Multiplex Test
Systems.
862.2570.................. Real Time Nucleic Acid OOI
Amplification System.
862.2570.................. Mass Spectrometer For OTA
Clinical Multiplex Test
Systems.
862.2570.................. Micro Total Analysis OUE
Instrument System.
862.2570.................. Complete Gene Expression OVA
Profiling Accessory
Reagents.
862.2570.................. DNA Genetic Analyzer..... PCA
862.2570.................. Data Acquisition Software PQQ
862.3200.................. Calibrators, Drug Mixture DKB
862.3200.................. Calibrators, Drug DLJ
Specific.
[[Page 31978]]
862.3200.................. Calibrators, Ethyl DNN
Alcohol.
864.5400.................. Fibrometer............... GIE
864.5400.................. Timer, Coagulation....... JBT
864.5425.................. Control, Plasma, Abnormal GGC
864.5425.................. Plasma, Coagulation GGN
Control.
864.5425.................. Plasma, Control, Normal.. GIZ
864.6550.................. Control, Fecal Occult OSL
Blood.
864.6650.................. Study, Platelet Adhesive. JBZ
864.7275.................. Test, Euglobulin Lysis... JBO
864.7300.................. Fibrin Monomer JBN
Paracoagulation.
864.7340.................. Fibrinogen Standard...... GFX
864.7340.................. Plasma, Fibrinogen GIL
Control.
864.7375.................. Glutathione, Red-Cell.... GII
864.7375.................. Fluorescence, Visual JMH
Observation (Qual.,
U.V.), Glutathione
Reductase.
864.7375.................. Assay, Glutathione KQF
Reductase.
864.7415.................. Control, Hemoglobin, JCM
Abnormal.
864.7455.................. Stain, Fetal Hemoglobin.. GHQ
864.7500.................. Acid Hematin............. GGF
864.7720.................. Test, Prothrombin GGQ
Consumption.
864.7735.................. Prothrombin-Proconvertin JPF
and Thrombotest.
864.8150.................. Calibrator for Cell KRX
Indices.
864.8165.................. Calibrator for Hemoglobin KRZ
and Hematocrit
Measurement.
864.8175.................. Calibrator for Platelet KRY
Counting.
864.8185.................. Calibrator for Red-Cell KSA
and White-Cell Counting.
864.8625.................. Standards and Controls, GFS
Hemoglobin, Normal and
Abnormal.
864.8625.................. Control, White-Cell...... GGL
864.8625.................. Control, Hemoglobin...... GGM
864.8625.................. Control, Platelet........ GJP
864.8625.................. Control, Red-Cell........ GJR
864.8625.................. Control, Hematocrit...... GLK
864.8625.................. Mixture, Control, White- GLQ
Cell and Red-Cell
Indices.
864.8625.................. Control, Cell Counter, JCN
Normal and Abnormal.
864.8625.................. Mixture, Hematology JPK
Quality Control.
864.8625.................. Material, Quality NRF
Control, Semen Analysis.
864.8625.................. Control Material, Blood NRS
Circulating Epithelial
Cancer Cell.
864.9400.................. Solution, Stabilized KSK
Enzyme.
866.3395.................. Norovirus Serological OUC
Reagents.
866.5210.................. Immunochemical, CHN
Ceruloplasmin.
866.5210.................. Ceruloplasmin, Rhodamine, DCT
Antigen, Antiserum,
Control.
866.5210.................. Ceruloplasmin, FITC, DCY
Antigen, Antiserum,
Control.
866.5210.................. Ceruloplasmin, Antigen, DDB
Antiserum, Control.
866.5210.................. P-Phenyl-Enediamine/EDTA JFQ
(Spectrophotometric),
Ceruloplasmin.
866.5210.................. Indirect Copper Assay, JFR
Ceruloplasmin.
866.5470.................. Hemoglobin, Chain DAM
Specific, Antigen,
Antiserum, Control.
866.5620.................. Alpha-2-Macroglobulin, DDT
Rhodamine, Antigen,
Antiserum, Control.
866.5620.................. Alpha-2-Macroglobulin, DDY
FITC, Antigen,
Antiserum, Control.
866.5620.................. Alpha-2-Macroglobulin, DEB
Antigen, Antiserum,
Control.
866.5630.................. System, Test, Beta-2- JZG
Microglobulin
Immunological.
866.5910.................. Quality Control Material, NZB
Genetics, DNA.
868.1040.................. Algesimeter, Powered..... BSI
868.1400.................. Legging, Compression, Non- LLK
Inflatable.
868.2500.................. Monitor, Oxygen, KLK
Cutaneous, For Infant
Not Under Gas Anesthesia.
868.2500.................. Monitor, Oxygen, LPP
Cutaneous, For Uses
Other Than For Infant
Not Under Gas Anesthesia.
868.2550.................. Pneumotachometer......... JAX
868.5180.................. Bed, Rocking, Breathing CCO
Assist.
868.6250.................. Compressor, Air, Portable BTI
870.1390.................. Trocar................... DRC
870.1875.................. Lung Sound Monitor....... OCR
870.2675.................. Oscillometer............. DRZ
870.4280.................. Filter, Prebypass, KRJ
Cardiopulmonary Bypass.
870.4290.................. Adaptor, Stopcock, DTL
Manifold, Fitting,
Cardiopulmonary Bypass.
870.4340.................. Monitor and/or Control, DTW
Level Sensing,
Cardiopulmonary Bypass.
870.4420.................. Sucker, Cardiotomy DTS
Return, Cardiopulmonary
Bypass.
870.4430.................. Suction Control, DWD
Intracardiac,
Cardiopulmonary Bypass.
872.1720.................. Tester, Pulp............. EAT
872.3260.................. External Cleaning PME
Solution.
872.3300.................. Coating, Denture EBE
Hydrophilic, Resin.
872.3540.................. Pad, Denture, Over The EHR
Counter.
872.3540.................. Cushion, Denture, Over EHS
The Counter.
872.3560.................. Reliner, Denture, Over EBP
The Counter.
872.3590.................. Denture, Plastic, Tooth.. ELM
[[Page 31979]]
872.3600.................. Denture Preformed EKO
(Partially Prefabricated
Denture).
872.3890.................. Splint, Endodontic ELS
Stabilizing.
872.5550.................. Ring, Teething, Fluid- KKO
Filled.
872.6770.................. Syringe, Cartridge....... EJI
874.1120.................. Generator, Electronic ETS
Noise (for Audiometric
Testing).
874.1325.................. Electroglottograph....... KLX
874.3310.................. Calibrator, Hearing Aid/ ETW
Earphone and Analysis
Systems.
874.3320.................. Hearing Aid, Group and EPF
Auditory Trainer.
874.3320.................. Device, Assistive LZI
Listening.
874.3330.................. Hearing Aid, Master...... KHL
874.3430.................. Mold, Middle-Ear......... ETC
874.3730.................. Device, Voice MCK
Amplification.
876.1500.................. Light Source, FCQ
Incandescent, Diagnostic.
876.1500.................. Light Source, FCR
Photographic, Fiberoptic.
876.1500.................. Light Source, Fiberoptic, FCW
Routine.
876.1500.................. Carrier, Sponge, FGS
Endoscopic.
876.1500.................. Light Source, Endoscope, GCT
Xenon Arc.
876.1500.................. Transformer, Endoscope... GCW
876.1500.................. LED Light Source......... NTN
876.1500.................. Endoscopic Guide Wire, OCY
Gastroenterology-Urology.
876.4020.................. Light, Catheter, FCS
Fiberoptic, Glass,
Ureteral.
876.4270.................. Rod, Colostomy........... EZP
876.4400.................. Ligator, Hemorrhoidal.... FHN
876.4400.................. Ligator, Esophageal...... MND
876.4500.................. Lithotriptor, Biliary LQC
Mechanical.
876.4770.................. Urethrotome.............. EZO
876.5010.................. Bag, Bile Collecting..... EXF
876.5025.................. Vibrator for Climax PIA
Control of Premature
Ejaculation.
876.5365.................. Dilator, Esophageal EZM
(Metal Olive) Gastro-
Urology.
876.5365.................. Bougie, Esophageal, and FAT
Gastrointestinal, Gastro-
Urology.
876.5365.................. Dilator, Esophageal...... KNQ
876.5520.................. Dilator, Urethral........ KOE
876.5665.................. Disinfectant, Subsystem, NIH
Water Purification.
876.5820.................. Set, Dialyzer Holder..... FKI
876.5895.................. Irrigator, Ostomy........ EXD
876.5980.................. Catheter, Retention, FGD
Barium Enema With Bag.
876.5980.................. Gastrostomy Tube Holder.. PLI
878.4370.................. Drape, Surgical, ENT..... ERY
878.4370.................. Drape, Pure Latex Sheet, EYX
With Self-Retaining
Finger Cot.
878.4370.................. Drape, Urological, EYY
Disposable.
878.4370.................. Pad, Kelly............... FNW
878.4370.................. Drape, Patient, HMT
Ophthalmic.
878.4370.................. Drape, Microscope, HMW
Ophthalmic.
878.4370.................. Ring (Wound Protector), KGW
Drape Retention,
Internal.
878.4580.................. Lamp, Operating-Room..... FQP
878.4580.................. Light, Surgical, FSQ
Instrument.
878.4580.................. Light, Surgical, Floor FSS
Standing.
878.4580.................. Light, Surgical, FSW
Endoscopic.
878.4580.................. Light, Surgical, FSX
Connector.
878.4580.................. Light, Surgical, Ceiling FSY
Mounted.
878.4580.................. Light, Surgical, Carrier. FSZ
878.4580.................. Light, Surgical, FTA
Accessories.
878.4580.................. Lamp, Surgical........... FTD
878.4580.................. Illuminator, Remote...... FTG
878.4580.................. Lamp, Surgical, GBC
Incandescent.
878.5070.................. Apparatus, Air Handling, FZG
Bench.
878.5070.................. Apparatus, Air Handling, FZH
Room.
878.5070.................. Apparatus, Air Handling, FZI
Enclosure.
880.5580.................. Locator, Acupuncture BWJ
Point.
880.5580.................. Needle, Acupuncture, MQX
Single Use.
880.5780.................. Stocking, Medical Support DWL
(to Prevent Pooling of
Blood in Legs).
882.1020.................. Analyzer, Rigidity....... GZM
882.1540.................. Device, Galvanic Skin GZO
Response Measurement.
882.1560.................. Device, Skin Potential HCJ
Measurement.
882.1855.................. Encephalogram Telemetry GYE
System.
882.5895.................. Vibratory Counter- OVP
Stimulation.
884.2990.................. Sheet, Recording, Breast NHM
Examination.
884.3200.................. Drain, Cervical.......... HFL
884.4400.................. Forceps, Obstetrical..... HDA
884.4530.................. Clamp, Umbilical......... HFW
884.4530.................. Speculum, Vaginal, HIB
Nonmetal.
[[Page 31980]]
884.4530.................. Speculum, Vaginal, HIC
Nonmetal, Fiberoptic.
884.4530.................. Clamp and Cutter, NBZ
Umbilical.
884.4900.................. Table, Obstetrical, AC- HDD
Powered (and
Accessories).
884.4900.................. Table, Obstetrical, HHP
Manual (and Accessories).
884.4900.................. Table, Obstetric (and KNC
Accessories).
884.5200.................. Hemorrhoid Prevention OOA
Pressure Wedge.
884.5390.................. Heater, Perineal, Direct HGZ
Contact.
884.5390.................. Heater, Perineal, HHA
Radiant, Non-Contact.
884.5390.................. Heater, Perineal......... KND
884.5400.................. Cup, Menstrual........... HHE
884.5425.................. Pad, Menstrual, Scented.. HHL
884.6150.................. Micromanipulators and MQJ
Microinjectors, Assisted
Reproduction.
886.1120.................. Photorefractor........... MMF
886.1120.................. Camera, Ophthalmic, PJZ
General-Use.
886.1250.................. Euthyscope, AC-Powered... HMK
886.1570.................. Ophthalmoscope, AC- HLI
Powered.
886.1570.................. Ophthalmoscope, Battery- HLJ
Powered.
886.1570.................. Ophthalmoscopes, MSG
Replacement Batteries,
Hand-Held.
886.1780.................. Retinoscope, AC-Powered.. HKL
886.1945.................. Transilluminator, AC- HJM
Powered.
886.4150.................. Tubing, Replacement, MSR
Phacofragmentation Unit.
886.4250.................. Unit, Electrolysis, AC- HRO
Powered, Ophthalmic.
886.4335.................. Headlight, Fiberoptic FCT
Focusing.
886.4335.................. Light, Headband, Surgical FSR
886.4335.................. Headlamp, Operating, AC- HPQ
Powered.
886.4400.................. Locator, Metal, HPM
Electronic.
886.4440.................. Magnet, AC-Powered....... HPO
886.4790.................. Sponge, Ophthalmic....... HOZ
886.4790.................. Eye Tray................. OJK
888.1240.................. Dynamometer, AC-Powered.. LBB
888.4580.................. Instrument, Surgical, JDX
Sonic and Accessory/
Attachment.
888.4580.................. System, Cement Removal LZV
Extraction.
890.1450.................. Hammer, Reflex, Powered.. IKO
890.5100.................. Bath, Hydro-Massage...... ILJ
890.5100.................. Bath, Sitz, Powered...... ILM
890.5110.................. Bath, Paraffin........... IMC
890.5250.................. Cabinet, Moist Steam..... IMB
890.5360.................. Exerciser, Measuring..... ISD
890.5500.................. Lamp, Infrared, ILY
Therapeutic Heating.
890.5575.................. Device, Warning, IRN
Overload, External Limb,
Powered.
892.1000.................. MRI Disposable Kit....... OIM
892.1560.................. Biopsy Needle Guide Kit.. OIJ
892.1610.................. Aperature, Radiographic.. IZS
892.1610.................. Cone, Radiographic....... IZT
892.1610.................. Collimator, Automatic, IZW
Radiographic.
892.1610.................. Collimator, Manual, IZX
Radiographic.
892.1610.................. Device, Beam Limiting, X- KPW
Ray, Diagnostic.
892.1650.................. Arthrogram Tray.......... OII
892.1650.................. Radiology Dental Tray.... OIK
892.1670.................. Device, Spot-Film........ IXL
892.1680.................. Radiographic Contrast OIO
Tray.
892.1680.................. Radiology Diagnostic Kit. OIP
892.1730.................. Discography Kit.......... OIL
892.1820.................. Chair, HBK
Pneumocephalographic.
892.1850.................. Cassette, Radiographic IXA
Film.
892.1860.................. Changer, Radiographic KPX
Film/Cassette.
892.1870.................. Programmer, Changer, Film/ IZP
Cassette, Radiographic.
892.1900.................. Controller, Temperature, EGT
Radiographic.
892.1900.................. Dryer, Film, Radiographic EGW
892.1900.................. Processor, Radiographic- EGY
Film, Automatic, Dental.
892.1900.................. Processor, Radiographic- IXW
Film, Automatic.
892.1900.................. Processor, Cine Film..... IXX
892.2030.................. Digitizer, Image, LMA
Radiological.
892.2030.................. Digitizer, Images, NFH
Ophthalmic.
892.2040.................. Camera, Multi Format, LMC
Radiological.
892.2040.................. Device, Hardcopy, Images, NFI
Ophthalmic.
892.5730.................. Prostate Seeding Kit..... OIN
------------------------------------------------------------------------
[[Page 31981]]
In table 2, FDA is identifying a list of class II devices that no
longer require premarket notification under section 510(k) of the FD&C
Act, subject to the general limitations to the exemptions found in
Sec. Sec. 862.9 to 892.9, as well as the indicated partial exemption
limitations. Devices listed in table 2 are now exempt, but only if they
are in concurrent compliance with both the partial exemption limitation
specified in table 2 and its corresponding general limitation found in
the .9 section of Parts 862 to 892 of Title 21 of the CFR.
Table 2--Class II Devices
----------------------------------------------------------------------------------------------------------------
Exempt product Former product Partial exemption
21 CFR Section Device type code code (non-exempt) limitation
----------------------------------------------------------------------------------------------------------------
862.3100....................... Enzyme PUX.............. DKZ.............. Exemption is limited
Immunoassay, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Radioimmunoassay, PUX.............. DJP.............. Exemption is limited
Amphetamine. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Thin Layer PUX.............. DIT.............. Exemption is limited
Chromatography, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Gas PUX.............. DOD.............. Exemption is limited
Chromatography, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Liquid PUX.............. DNI.............. Exemption is limited
Chromatography, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3100....................... Free Radical PUX.............. DJL.............. Exemption is limited
Assay, to test systems
Amphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Enzyme PUY.............. DIS.............. Exemption is limited
Immunoassay, to test systems
Barbiturate. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
[[Page 31982]]
862.3150....................... Radioimmunoassay, PUY.............. DKN.............. Exemption is limited
Barbiturate. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Thin Layer PUY.............. DKX.............. Exemption is limited
Chromatography, to test systems
Barbiturate. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Mercury PUY.............. DJN.............. Exemption is limited
Dithiazone, to test systems
Colorimetry, intended for
Barbiturate. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Hemagglutination PUY.............. DLX.............. Exemption is limited
Inhibition, to test systems
Barbiturate. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... Gas Liquid PUY.............. DMF.............. Exemption is limited
Chromatography, to test systems
Barbiturate. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3150....................... High Pressure PUY.............. KZY.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Barbiturate. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3170....................... Enzyme PUZ.............. JXM.............. Exemption is limited
Immunoassay, to test systems
Benzodiazepine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3170....................... High Pressure PUZ.............. LAA.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Benzodiazepine. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
[[Page 31983]]
862.3170....................... Test, PUZ.............. NFV.............. Exemption is limited
Benzodiazepine, to test systems
Over The Counter. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3170....................... Gas PUZ.............. KZZ.............. Exemption is limited
Chromatography, to test systems
Benzodiazepine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3170....................... Thin Layer PUZ.............. LAB.............. Exemption is limited
Chromatography, to test systems
Benzodiazepine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Enzyme PVA.............. DIO.............. Exemption is limited
Immunoassay, to test systems
Cocaine and intended for
Cocaine employment and
Metabolites. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Radioimmunoassay, PVA.............. KLN.............. Exemption is limited
Cocaine to test systems
Metabolite. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Enzyme PVA.............. JXO.............. Exemption is limited
Immunoassay, to test systems
Cocaine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Hemagglutination, PVA.............. DLN.............. Exemption is limited
Cocaine to test systems
Metabolites intended for
(Benzoylecgonine employment and
). insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Thin Layer PVA.............. DMN.............. Exemption is limited
Chromatography, to test systems
Cocaine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
[[Page 31984]]
862.3250....................... Free Radical PVA.............. DIR.............. Exemption is limited
Assay, Cocaine. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Gas PVA.............. DIN.............. Exemption is limited
Chromatography, to test systems
Cocaine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... Thin Layer PVA.............. DOM.............. Exemption is limited
Chromatography, to test systems
Benzoylecgonine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3250....................... High Pressure PVA.............. LAC.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Cocaine and employment and
Cocaine insurance testing
Metabolites. that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3270....................... High Pressure PVB.............. LAE.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Codeine. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3270....................... Thin Layer PVB.............. DLD.............. Exemption is limited
Chromatography, to test systems
Codeine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3270....................... Gas PVB.............. LAD.............. Exemption is limited
Chromatography, to test systems
Codeine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3580....................... Radioimmunoassay, PVC.............. DLB.............. Exemption is limited
LSD (125-I). to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
[[Page 31985]]
862.3580....................... Free Radical PVC.............. DOL.............. Exemption is limited
Assay, LSD. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3610....................... Gas PVD.............. LAF.............. Exemption is limited
Chromatography, to test systems
Methamphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3610....................... Thin Layer PVD.............. DJC.............. Exemption is limited
Chromatography, to test systems
Methamphetamine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3610....................... High Pressure PVD.............. LAG.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Methamphetamine. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3610....................... Test, PVD.............. NGG.............. Exemption is limited
Methamphetamine, to test systems
Over The Counter. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Enzyme PVE.............. DJR.............. Exemption is limited
Immunoassay, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Hemagglutination PVE.............. DIW.............. Exemption is limited
Inhibition, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Gas PVE.............. DMB.............. Exemption is limited
Chromatography, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
[[Page 31986]]
862.3620....................... Thin Layer PVE.............. DKR.............. Exemption is limited
Chromatography, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Liquid PVE.............. DNT.............. Exemption is limited
Chromatography, to test systems
Methadone. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3620....................... Free Radical PVE.............. DPP.............. Exemption is limited
Assay, Methadone. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3630....................... Radioimmunoassay, PVF.............. KXS.............. Exemption is limited
Methaqualone. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Thin Layer PVG.............. DNK.............. Exemption is limited
Chromatography, to test systems
Morphine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Radioimmunoassay, PVG.............. DOE.............. Exemption is limited
Morphine (123- to test systems
I), Goat intended for
Antibody employment and
Ammonium Sulfate insurance testing
Sep.. that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Fluorometry, PVG.............. DJJ.............. Exemption is limited
Morphine. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Liquid PVG.............. DPK.............. Exemption is limited
Chromatography, to test systems
Morphine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
[[Page 31987]]
862.3640....................... Gas PVG.............. DMY.............. Exemption is limited
Chromatography, to test systems
Morphine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Hemagglutination PVG.............. DLR.............. Exemption is limited
Inhibition, to test systems
Morphine. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Free Radical PVG.............. DOK.............. Exemption is limited
Assay, Morphine. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Radioimmunoassay, PVG.............. DIQ.............. Exemption is limited
Morphine (3-H), to test systems
Goat Antibody intended for
Ammonium Sulfate employment and
Sep.. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3640....................... Radioimmunoassay, PVG.............. DNA.............. Exemption is limited
Morphine- to test systems
Barbiturate (125- intended for
I), Goat employment and
Antibody. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... Enzyme PVH.............. DJG.............. Exemption is limited
Immunoassay, to test systems
Opiates. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... Gas PVH.............. DJF.............. Exemption is limited
Chromatography, to test systems
Opiates. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... Hemagglutination, PVH.............. DLT.............. Exemption is limited
Opiates. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
[[Page 31988]]
862.3650....................... Thin Layer PVH.............. LAI.............. Exemption is limited
Chromatography, to test systems
Opiates. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... Free Radical PVH.............. DKT.............. Exemption is limited
Assay, Opiates. to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3650....................... High Pressure PVH.............. LAH.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Opiates. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3700....................... Enzyme PVI.............. JXN.............. Exemption is limited
Immunoassay, to test systems
Propoxyphene. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3700....................... Thin Layer PVI.............. DPN.............. Exemption is limited
Chromatography, to test systems
Propoxyphene. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3700....................... Gas PVI.............. LAJ.............. Exemption is limited
Chromatography, to test systems
Propoxyphene. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3700....................... High Pressure PVI.............. LAK.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Propoxyphene. employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3870....................... Enzyme PVJ.............. LDJ.............. Exemption is limited
Immunoassay, to test systems
Cannabinoids. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
[[Page 31989]]
862.3870....................... Reagents, Test, PVJ.............. DKE.............. Exemption is limited
Tetrahydrocannab to test systems
inol. intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3870....................... Radioimmunoassay, PVJ.............. LAT.............. Exemption is limited
Cannabinoid(S). to test systems
intended for
employment and
insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3910....................... High Pressure PVK.............. LFI.............. Exemption is limited
Liquid to test systems
Chromatography, intended for
Tricyclic employment and
Antidepressant insurance testing
Drugs. that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3910....................... U.V. PVK.............. LFH.............. Exemption is limited
Spectrometry, to test systems
Tricyclic intended for
Antidepressant employment and
Drugs. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
862.3910....................... Thin Layer PVK.............. MLK.............. Exemption is limited
Chromatography, to test systems
Tricyclic intended for
Antidepressant employment and
Drugs. insurance testing
that include a
statement in their
labeling that the
device is intended
solely for use in
employment and
insurance testing,
and does not include
test systems intended
for Federal drug
testing programs
(e.g., programs run
by the Substance
Abuse and Mental
Health Services
Administration
(SAMHSA), the
Department of
Transportation (DOT),
and the U.S.
military.)
866.5750....................... System, Test, PUW.............. DHB.............. Exemption is limited
Radioallergosorb to devices classified
ent (RAST) under 21 CFR 866.5750
Immunological. that are intended to
detect any of the
allergens included in
table 3 of this
document.
868.2385....................... Analyzer, PUG.............. MRQ.............. Exemption is limited
Nitrogen Dioxide. to standalone
nitrogen dioxide
analyzers and not
those that are
components of nitric
oxide delivery
systems intended to
monitor nitrogen
dioxide levels during
inhaled nitric oxide
therapy.
870.1330....................... Wire, Guide, PTL.............. DQX.............. Exemption is limited
Catheter. to accessory torque
devices that are
manually operated,
non-patient
contacting, and
intended to
manipulate non-
cerebral vascular
guide wires.
870.1650....................... Syringe, Balloon PTM.............. MAV.............. Exemption is limited
Inflation. to non-patient
contacting balloon
inflation syringes
intended only to
inflate/deflate
balloon catheters and
monitor pressure
within the balloon.
870.2770....................... Analyzer, Body PUH.............. MNW.............. Exemption is limited
Composition. to body composition
analyzers which are
not intended to
diagnose or treat any
medical condition.
870.4400....................... Reservoir, Blood, PTN.............. DTN.............. Exemption is limited
Cardiopulmonary to cardiopulmonary
Bypass. bypass blood
reservoirs that do
not contain defoamers
or blood filters.
874.1090....................... Tester, Auditory PTO.............. ETY.............. Exemption is limited
Impedance. to auditory impedance
testers that are in
compliance with FDA-
recognized consensus
standard ANSI S3.39.
874.1090....................... Tympanometer..... PTP.............. NAS.............. Exemption is limited
to tympanometers that
are in compliance
with FDA-recognized
consensus standard
ANSI S3.39.
876.1500....................... Endoscopic PTQ.............. FCC.............. Exemption is limited
Magnetic to endoscopic
Retriever. magnetic retrievers
intended for single
use.
876.1500....................... Scissors For PTR.............. KGD.............. Exemption is limited
Cystoscope. to sterile scissors
for cystoscope
intended for single
use.
[[Page 31990]]
876.1500....................... Endoscopic PTS.............. OCZ.............. Exemption is limited
Grasping/Cutting to disposable, non-
Instrument, Non- powered endoscopic
Powered. grasping/cutting
instruments intended
for single use.
876.5010....................... Catheter, PTT.............. GCA.............. Exemption is limited
Biliary, to surgical biliary
Surgical. catheters that do not
include a balloon
component.
876.5630....................... Catheter, PTU.............. FJS.............. Exemption is limited
Peritoneal, Long- to non-patient
Term Indwelling. contacting catheter
finger grips intended
for single use.
876.5630....................... Catheter, PTV.............. FKO.............. Exemption is limited
Peritoneal to non-patient
Dialysis, Single contacting catheter
Use. finger grips intended
for single use.
876.5630....................... System, PTW.............. FKX.............. Exemption is limited
Peritoneal, to continuous
Automatic ambulatory peritoneal
Delivery. dialysis (CAPD) belts
and catheter stands
that do not include
weigh scales.
878.4370....................... Drape, Surgical.. PUI.............. KKX.............. Exemption is limited
to surgical drapes
that do not include
an antimicrobial
agent.
878.4495....................... Suture, PTX.............. GAQ.............. Exemption is limited
Nonabsorbable, to steel monofilament
Steel, sutures that are
Monofilament And uncoated and do not
Multifilament, incorporate barbs.
Sterile.
882.1470....................... Computerized PTY.............. PKQ.............. Exemption is limited
Cognitive to computerized
Assessment Aid. cognitive assessment
aids that are not
intended for
diagnostic assessment
of specific diseases
or conditions and
rely on inputs from
visual cues, auditory
cues, and/or
functional use of the
hand.
884.1630....................... Colposcope (and PTZ.............. HEX.............. Exemption is limited
Colpomicroscope). to standard
colposcopes (and
colpomicroscopes)
that use only a white
light source, do not
use filters other
than a green filter,
do not include image
analysis software,
and are not
smartphone-based.
884.4530....................... Tenaculum, PUA.............. HDC.............. Exemption is limited
Uterine. to sterile uterine
tenaculum devices
that do not use
suction and are
intended for single
use.
884.6120....................... Accessory, PUB.............. MQG.............. Exemption is limited
Assisted to simple embryo
Reproduction. incubators with
temperature, gas, and
humidity control
only; syringe pumps;
collection tube
warmers; dish/plate/
microscope stage
warmers; and
controlled-rate
cryopreservation
freezers.
884.6130....................... Microtools, PUC.............. MQH.............. Exemption is limited
Assisted to assisted
Reproduction reproduction
(Pipettes). microtools (pipettes)
manufactured from
glass.
884.6160....................... Labware, Assisted PUD.............. MQK.............. Exemption is limited
Reproduction. to dishes and plates
that are intended for
general assisted
reproduction
technology
procedures.
886.1850....................... Biomicroscope, PUE.............. HJO.............. Exemption is limited
Slit-Lamp, AC- to slit-lamp, AC-
Powered. powered
biomicroscopes
intended only for the
visual examination of
the anterior segment
of the eye, are
classified as Group 1
per FDA-recognized
consensus standard
ANSI Z80.36, do not
provide any
quantitative output,
and are not intended
for screening or
automated diagnostic
indications.
886.3320....................... Ocular Peg....... PUF.............. MQU.............. Exemption is limited
to ocular pegs
supplied sterile.
----------------------------------------------------------------------------------------------------------------
In table 2, FDA included devices classified under Sec. 866.5750
(Radioallergosorbent (RAST) immunological test system). FDA does not
believe that all devices classified under this regulation meet the
exemption criteria from premarket notification requirements. The
devices listed in table 3 are also classified under Sec. 866.5750, but
this subset no longer requires premarket notification under section
510(k) of the FD&C Act, subject to the general limitations to the
exemptions found in Sec. 866.9. While the non-exempt devices
classified under Sec. 866.5750 will retain product code ``DHB'', these
devices listed in table 3 are reassigned product code ``PUW.''
Table 3--Class II Devices
[Sec. 866.5750--Radioallergosorbent (RAST) Immunological Test Systems]
------------------------------------------------------------------------
Source (taxonomical
Allergen code Allergen product name)
------------------------------------------------------------------------
Grass Pollens
------------------------------------------------------------------------
g1.................... Sweet vernal grass..... Anthoxanthum odoratum.
g3.................... Cocksfoot grass, Dactylis glomerata.
Orchard grass.
g4.................... Meadow fescue.......... Festuca elatior.
g5.................... Rye-grass (perennial Lolium perenne.
rye grass).
g7.................... Common reed (common Phragmites communis.
reed grass).
g8.................... Meadow grass, Kentucky Poa pratensis.
blue (June grass).
[[Page 31991]]
g9.................... Redtop, Bentgrass...... Agrostis stolonifera
Agrostis gigantea
(Agrostis alba).
g11................... Brome grass............ Bromus inermis.
g12................... Cultivated rye Secale cereale.
(cultivated rye grass).
g13................... Velvet grass........... Holcus lanatus.
g14................... Cultivated oat Avena sativa.
(cultivated oat grass).
g15................... Cultivated wheat Triticum aestivum
(cultivated wheat (Triticum spp.).
grass).
g16................... Meadow foxtail (meadow Alopecurus pratensis.
foxtail grass).
g17................... Bahia grass............ Paspalum notatum.
g24................... Wheat grass, Western... Agropyron smithii
(Elymus smithii).
g30................... Bluegrass, annual...... Poa annua.
g70................... Wild rye grass......... Elymus triticoides
Elymus condensatus.
g71................... Canary grass........... Phalaris arundinacea.
g201.................. Barley, cultivated..... Hordeum vulgare.
g202.................. Maize, corn (cultivated Zea mays.
corn).
g203.................. Salt grass............. Distichlis spicata.
g204.................. False oat-grass........ Arrhenatherum elatius.
g216.................. Cyn d 1................ Cynodon dactylon.
g701.................. Phl p 1.0102, Phl p Phleum pratense.
5.0101.
g702.................. Phl p 7.0101........... Phleum pratense.
g703.................. Phl p 12.0101.......... Phleum pratense.
------------------------------------------------------------------------
Weed Pollens
------------------------------------------------------------------------
w2.................... Western ragweed........ Ambrosia psilostachya.
w4.................... False ragweed.......... Ambrosia acanthicarpa
(Franseria
acanthicarpa).
w5.................... Wormwood............... Artemisia absinthium
Artemisia annua.
w6.................... Mugwort................ Artemisia vulgaris.
w7.................... Marguerite, ox-eye Chrysanthemum
daisy. leucanthemum.
w8.................... Dandelion.............. Taraxacum vulgare
Taraxacum officinale.
w9.................... Plantain (English), Plantago lanceolata.
Ribwort.
w10................... Goosefoot, lamb's Chenopodium album.
quarters.
w11................... Saltwort (prickly), Salsola kali
Russian thistle. (Salsola pestifer).
w12................... Goldenrod.............. Solidago virgaurea
(Solidago spp.)
w13................... Cocklebur, common...... Xanthium commune.
w14................... Common pigweed (rough Amaranthus retroflexus.
pigweed).
w15................... Scale, Lenscale........ Atriplex lentiformis.
w16................... Rough marsh elder...... Iva ciliate
Iva annua.
w17................... Firebush (Kochia)...... Kochia scoparia.
w18................... Sheep sorrel........... Rumex acetosella.
w19................... Wall pellitory......... Parietaria officinalis.
w20................... Nettle (Common stinging Urtica dioica.
nettle).
w21................... Wall pellitory......... Parietaria judaica.
w22................... Japanese hop (careless Humulus japonicas
weed). (Humulus scandens).
w23................... Yellow dock, Yellow Rumex crispus.
dockweed.
w24................... Spiny pigweed.......... Amaranthus spinosus.
w27................... Carnation.............. Dianthus spp.
w28................... Rose................... Rosa rugosa.
w33................... Clover................. Trifolium pratense.
w35................... Mexican tea............ Chenopodium
ambrosioides.
w36................... Rabbit bush............ Ambrosia deltoidea
(Franseria deltoides).
w37................... Salt bush, annual...... Atriplex wrightii.
w39................... Water hemp, Western.... Amaranthus rudis
(Acnida tamariscina).
w41................... Burrobrush............. Hymenoclea salsola.
w42................... Poverty weed...........
w43................... Common sagebrush....... Artemisia tridentata.
w45................... Alfalfa................ Medicago sativa.
w46................... Dog fennel............. Eupatorium
capillifolium.
[[Page 31992]]
w53................... Geranium............... Geranium spp.
w67................... Groundsel bush......... Baccharis halimifolia.
w69................... Iodine bush............ Allenrolfea
occidentalis.
w70................... Ragweed, slender....... Ambrosia confertiflora.
w75................... Wing scale (wingscale). Atriplex canescens.
w82................... Careless weed.......... Amaranthus palmeri
Amaranthus hybridus.
w90................... Japanese hop........... Humulus japonicas
(Humulus scandens).
w203.................. Rape (rape pollen)..... Brassica napus.
w204.................. Sunflower.............. Helianthus annuus.
w206.................. Camomile............... Matricaria chamomilla.
w207.................. Lupin.................. Lupinus spp.
w210.................. Sugar-beet............. Beta vulgaris.
w211.................. Par j 2.0101........... Parietaria judaica.
w231.................. Art v 1................ Artemisia vulgaris
(Mugwort).
w232.................. Sal k 1................ Salsola kali.
w233.................. Art v 3................ Artemisa vulgaris (LTP,
Mugwort).
w234.................. Pla l 1................ Plantago lanceolata.
w235.................. Che a 1.0101........... Chenopodium album.
w236.................. Mer a 1.0101........... Mercurialis annua.
a753.................. Art v 1................ Artemisia vulgaris
(Mugwort weed).
------------------------------------------------------------------------
Tree Pollens
------------------------------------------------------------------------
t1.................... Box-elder (Maple)...... Acer negundo.
Acer saccharum.
t2.................... Gray alder, speckled Alnus incana.
alder (alder).
t4.................... Hazel, hazelnut........ Corylus avellana.
Corylus americana.
t5.................... American beech (beech). Fagus grandifolia.
(Fagus americana).
t6.................... Mountain juniper, Juniperus ashei
Mountain cedar. (Juniperus sabinoides).
t8.................... Elm.................... Ulmus americana.
t9.................... Olive.................. Olea europaea.
t10................... Walnut................. Juglans californica
Juglans nigra.
t11................... Maple leaf sycamore, Platanus acerifolia.
London plane, Plane
tree.
t61................... Sycamore............... Platanus occidentalis.
t12................... Willow................. Salix caprea
Salix nigra.
t14................... Cottonwood (Eastern Populus deltoides.
Cottonwood/Black
Cottonwood).
t15................... White ash.............. Fraxinus americana.
t16................... White pine............. Pinus strobus.
t18................... Eucalyptus, gum-tree... Eucalyptus globulus.
(Eucalyptus spp.).
t19/t26............... Acacia................. Acacia longifolia
(Acacia spp.).
t20................... Mesquite............... Prosopis glandulosa/
Prosopis juliflora.
t21................... Melaleuca, cajeput tree Melaleuca quinquenervia
(Melaleuca
leucadendron).
t22................... Pecan, hickory......... Carya illinoinensis
(Carya pecan).
t23................... Italian/Mediterranean/ Cupressus sempervirens.
funeral cypress.
t24................... Japanese cypress....... Chamaecyparis obtusa
(Chamaecyparis spp.).
t25................... Ash.................... Fraxinus excelsior.
t27................... Maple, red............. Acer rubrum.
t29................... Acacia................. Acacia spp.
t30................... Birch, white........... Betula populifolia.
t32................... Willow, black.......... Salix nigra.
t33................... Ash, Arizona........... Fraxinus velutina.
t35................... Cedar, salt............ Tamarix gallica.
t37................... Bald cypress (white Taxodium distichum.
bald cypress).
t38................... Elm, Chinese/Siberian.. Ulmus pumila.
t40................... Hazelnut tree.......... Corylus americana.
t41................... White hickory.......... Carya alba
(Carya tomentosa).
t42................... Oak, red............... Quercus rubra.
t43................... Loblolly pine.......... Pinus taeda.
t44................... Hackberry.............. Celtis occidentalis.
[[Page 31993]]
t45................... Cedar elm.............. Ulmus crassifolia.
t47................... Juniper, one seed...... Juniperus monosperma.
t48................... Pine, lodgepole........ Pinus contorta.
t49................... Pine, ponderosa........ Pinus ponderosa.
t50................... Beech, European........ Fagus sylvatica.
t51................... Tree of Heaven......... Ailanthus altissima.
t52................... Western white pine..... Pinus monticola.
t54................... Russian olive.......... Elaeagnus angustifolia.
t55................... Scotch broom........... Cytisus scoparius.
t56................... Bayberry............... Myrica cerifera.
t57................... Red cedar.............. Juniperus virginiana.
t60................... Western juniper........ Juniperus occidentalis.
t61................... Sycamore............... Platanus occidentalis.
t70................... Mulberry (white Morus alba.
mulberry).
t71................... Red mulberry........... Morus rubra.
t72................... Queen palm............. Arecastrum
romanzoffiamon.
t73................... Australian pine........ Casuarina
equisetifolia.
t77................... Oak mix (red, white, Quercus spp.
black).
t80................... Japanese cypress....... Chamaecyparis obtusa.
t81................... Japanese alder......... Alnus japonica.
t83................... Mango tree............. Mangifera indica.
t90................... Walnut, black.......... Juglans nigra.
t96................... Poplar, white (poplar). Populus alba.
t103/................. Virginia live oak (live Quercus virginiana.
t218.................. oak).
t105.................. Pepper tree............ Schinus molle.
t110.................. Orange tree............ Citrus sinensis.
t201.................. Spruce, Norway spruce.. Picea abies (Picea
excelsa).
t202.................. Alder, smooth.......... Alnus incana spp.
Rugosa
(Alnus rugosa).
t203.................. Horse chestnut......... Aesculus hippocastanum.
t205.................. Elder.................. Sambucus nigra.
t206.................. Chestnut............... Castanea sativa.
t207.................. Douglas fir............ Pseudotsuga menziesii
(Pseudotsuga
taxifolia).
t208.................. Linden................. Tilia cordata.
t209.................. Horn beam.............. Carpinus betulus.
t210.................. Privet................. Ligustrum vulgare.
t211.................. Sweet gum.............. Liquidambar
styraciflua.
t212.................. Cedar.................. Libocedrus decurrens.
t213.................. Pine................... Pinus radiata.
t214.................. Date palm.............. Phoenix canariensis.
t215.................. Lilac.................. Syringa vulgaris.
t217.................. Pepper tree............ Schinus molle.
t217.................. Red alder.............. Alnus rubra.
t218.................. Virginia live oak...... Quercus virginiana.
t218.................. Bayberry (bayberry/ Myrica gale.
sweet gale).
t219.................. Palo verde............. Cercidium floridum.
t219.................. Red cedar.............. Juniperus virginiana.
t220.................. Bet v 4................ Betula verrucosa
(Birch).
t221.................. Bet v 2.0101, Bet v 4.. Betula verrucosa
(Birch).
t222.................. Cypress (Arizona Cupressus arizonica.
cypress).
t223.................. Oil palm............... Elaeis guineensis.
t224.................. Ole e 1................ Olea europaea.
t225.................. Bet v 6................ Betula verrucosa
(Birch).
t226.................. Cup a 1................ Cupressus arizonica.
t227.................. Ole e 7................ Olea Europaea.
t228.................. Aspen, quaking......... Populus tremuloides.
t229.................. Eastern hemlock........ Tsuga canadensis.
t230.................. Redwood (sequoia)...... Sequoia sempervirens.
t232.................. Pussy willow........... Salix discolor.
t240.................. Ole e 9.0101........... Olea Europaea.
t241.................. Pla a 1.0101........... Platanus acerifolia.
t242.................. Pla a 2................ Platanus acerifolia.
t243.................. Pla a 3.0101........... Platanus acerifolia.
t244.................. Cor a 1.0103........... Corylus avellana.
t245.................. Aln g 1.0101........... Alnus glutinosa.
t246.................. Cry j 1................ Cryptomeria japonica.
t280.................. Locust tree............ Robinia pseudoacacia.
t401.................. Brazilian peppertree... Schinus
terebinthifolius.
t402.................. Mastic tree............ Pistacia lentiscus.
[[Page 31994]]
t404.................. Tree of heaven......... Ailanthus altissima.
t406.................. Date palm.............. Phoenix dactylifera.
a482.................. Ole e 1................ Olea europaea (Olive
Oil).
------------------------------------------------------------------------
Mites
------------------------------------------------------------------------
d207.................. Blo t 5.0101........... Blomia tropicalis.
d208.................. Lep d 2.0101........... Lepidoglyphus
destructor.
------------------------------------------------------------------------
Microorganisms, Molds, Yeast
------------------------------------------------------------------------
m1.................... Penicillium chrysogenum Penicillium chrysogenum
(Penicillium notatum).. (Penicillium notatum).
m2.................... Cladosporium herbarum Cladosporium herbarum
(Hormodendrum). (Hormodendrum).
m3.................... Aspergillus fumigatus.. Aspergillus fumigatus.
m4.................... Mucor racemosus........ Mucor racemosus.
m5.................... Candida albicans....... Candida albicans.
m7.................... Botrytis cinerea....... Botrytis cinerea.
m8.................... Drechslera halodes Drechslera halodes
(Setomelanomma (Setomelanomma
rostrata, rostrata,
Helminthosporium Helminthosporium
halodes, halodes).
Helminthosporium
interseminatum).
m9.................... Fusarium moniliforme Fusarium moniliforme
(Fusarium (Fusarium
proliferatum). proliferatum).
m10................... Stemphylium botryosum.. Stemphylium herbarum
(Stemphylium
botryosum).
m11................... Rhizopus nigricans..... Rhizopus nigricans.
m12................... Aureobasidium pullulans Aureobasidium
pullulans.
m13................... Phoma betae............ Phoma betae.
m14................... Epicoccum purpurascens. Epicoccum purpurascens
(Epicoccum nigrum).
m15................... Trichoderma viride..... Trichoderma viride.
m16................... Curvularia lunata...... Curvularia lunata
Curvularia specifera
(K923044).
m17................... Cladosporium fulvum.... Cladosporium fulvum.
m18................... Fusarium culmorum...... Fusarium culmorum.
m19................... Aspergillus versicolor. Aspergillus versicolor.
m20................... Mucor mucedo........... Mucor mucedo.
m21................... Aspergillus clavatus... Aspergillus clavatus.
m22................... Micropolyspora faeni... Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m23................... Thermoactinomyces Thermoactinomyces
vulgaris. vulgaris.
m24................... Stachybotrys atra...... Stachybotrys chartarum
(Stachybotrys atra).
m24................... Paecilomyces spp....... Paecilomyces spp.
m25................... Aspergillus versicolor. Aspergillus versicolor.
m25................... Penicillium Penicillium
brevicompactum. brevicompactum.
m26................... Cladosporium Cladosporium
cladosporioides. cladosporioides.
m26................... Penicillium citrinum... Penicillium citrinum.
m27................... Penicillium spp........ Penicillium spp.
m29................... Aspergillus repens..... Aspergillus repens.
m30................... Penicillium roqueforti. Penicillium roqueforti.
m32................... Cladosporium Cladosporium
cladosporioides. cladosporioides.
m34................... Serpula lacrymans...... Serpula lacrymans.
m36................... Aspergillus terreus.... Aspergillus terreus.
m37................... Trichophyton Trichophyton
mentagrophytes. mentagrophytes.
m40................... Aspergillus amstelodami Aspergillus
amstelodami.
m43................... Saccharomyces carlsberg Saccharomyces
carlsbergensis.
m44................... Saccharomyces Saccharomyces
cerevisiae. cerevisiae.
m45................... Hormodendrum hordei.... Hormodendrum hordei.
m46................... Bipolaris spicifera.... Bipolaris spicifera.
m47................... Aspergillus nidulans... Aspergillus nidulans.
m48................... Aspergillus oryzae..... Aspergillus oryzae.
m49................... Fusarium oxysporum..... Fusarium oxysporum.
m50................... Micropolyspora faeni... Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m51................... Thermoactinomyces Thermoactinomyces
vulgaris. vulgaris.
m53................... Microspora canis....... Microsporum canis
(Microspora canis).
m54................... Aspergillus flavus..... Aspergillus flavus.
m63................... Helminthosporium Helminthosporium
intersemin. intersemin.
m66................... Mucor plumbeus......... Mucor plumbeus.
m67................... Mycogone............... Mycogone perniciosa.
m68................... Nigrospora oryzae...... Nigrospora oryzae.
[[Page 31995]]
m69................... Rhodotorula............ Rhodotorula rubra
(Rhodotorula
mucilaginosa).
m70................... Malassezia furfur Malassezia furfur
(Pityrosporum (Pityrosporum
orbiculare). orbiculare).
m71................... Spondylocladium........ Spondylocladium spp.
m72................... Epidermophyton......... Epidermophyton
floccosum.
m73................... Epicoccum nigrum....... Epicoccum purpurascens
(Epicoccum nigrum).
m80................... Staphylococcal Staphylococcus aureus.
enterotoxin A (Sta a
SEA).
m80................... Helminthosporium spp... Helminthosporium spp.
m81................... Staphylococcal Staphylococcus aureus.
enterotoxin B (Sta a
SEB).
m88................... Stemphylium solani..... Stemphylium solani.
m93................... Gliocladium fimbriatum. Gliocladium fimbriatum.
m94................... Phycomyces Phycomyces
blakesleeanus. blakesleeanus.
m201.................. Tilletia tritici Tilletia tritici
(Ustilago nuda, (Ustilago nuda,
Ustilago tritici) Ustilago tritici).
(Barley smut).
m202.................. Acremonium kiliense Acremonium kiliense
(Cephalosporium (Cephalosporium
acremonium). acremonium).
m203.................. Trichosporon pullulans. Trichosporon pullulans.
m204.................. Ulocladium chartarum... Ulocladium chartarum.
m205.................. Trichophyton rubrum.... Trichophyton rubrum.
m207.................. Aspergillus niger...... Aspergillus niger.
m208.................. Chaetomium globosum.... Chaetomium globosum.
m209.................. Penicillium frequentans Penicillium glabrum
(Penicillium
frequentans).
m209.................. Stachybotrys chartarum. Stachybotrys chartarum
(Stachybotrys atra).
m210.................. Trichophyton Trichophyton
mentagrophytes var. mentagrophytes var.
goetzii. goetzii.
m211.................. Trichophyton Trichophyton
mentagrophytes var. mentagrophytes var.
interdigitale. interdigitale.
m211.................. Oat smut............... Ustilago avenae.
m212.................. Micropolyspora faeni... Saccharopolyspora
rectivirgula
(Micropolyspora
faeni).
m212.................. Geotrichum candidum.... Geotrichum candidum.
m213.................. Bermuda grass smut..... Ustilago cynodontis.
m214.................. Johnson grass smut..... Sphacelotheca cruenta.
m215.................. Corn smut.............. Ustilago maydis.
m218.................. Asp f 1.0101........... Aspergillus fumigatus.
a3050................. Asp r 1................ Aspergillus restrictus.
m219.................. Asp f 2................ Aspergillus fumigatus.
m220.................. Asp f 3.0101........... Aspergillus fumigatus.
m221.................. Asp f 4................ Aspergillus fumigatus.
m222.................. Asp f 6.0101........... Aspergillus fumigatus.
m223.................. Staphylococal Staphylococus aureus.
enterotoxin C (Sta a
SEC).
m224.................. Staphylococcal Staphylococcus aureus.
enterotoxin D (Sta a
SED).
m226.................. Staphylococcal Staphylococcus aureus.
enterotoxin TSST (Sta
a TSST).
m227.................. Malassezia spp. Malassezia spp.
(Pityrosporum spp.). (Pityrosporum spp.).
m228.................. Aspergillus flavus.....
m229.................. Alt a 1.0101........... Alternaria alternata
(Alternaria tenuis).
m230.................. Alt a 6.0101........... Alternaria alternata
(Alternaria tenuis).
m231.................. Cla h 8.0101........... Cladosporium herbarum
(Hormodendrum).
m300.................. Eurotium spp........... Eurotium spp.
m304.................. Aspergillus oryzae..... Aspergillus oryzae.
m305.................. Penicillium Penicillium
brevicompactum. brevicompactum.
m309.................. Aspergillus terreus.... Aspergillus terreus.
m310.................. Aspergillus nidulans... Aspergillus nidulans.
m311.................. Aspergillus flavus..... Aspergillus flavus.
m312.................. Aspergillus clavatus... Aspergillus clavatus.
------------------------------------------------------------------------
Epidermal & Animal
------------------------------------------------------------------------
e6.................... Guinea pig epithelium.. Cavia porcellus.
e7.................... Pigeon droppings....... Columba palumbus
Columba livia.
e25................... Chicken serum.......... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e26................... Parrot serum........... Psittacoidea spp.
e62................... Camel.................. Camelus dromedaries.
e70................... Goose feathers......... Anser anser.
e71................... Mouse epithelium....... Mus musculus
(Mus spp.).
e73................... Rat epithelium......... Rattus norvegicus.
e74................... Rat urine proteins..... Rattus norvegicus
Rattus rattus.
[[Page 31996]]
e75................... Rat serum proteins..... Rattus norvegicus
Rattus rattus.
e76................... Mouse serum proteins... Mus musculus
(Mus spp.).
e77................... Budgerigar droppings... Melopsittacus
undulatus.
e78................... Budgerigar feathers.... Melopsittacus
undulatus.
e79................... Budgerigar serum Melopsittacus
proteins. undulatus.
e80................... Goat epithelium........ Capra hircus.
e81................... Sheep epithelium....... Ovis aries
(Ovis spp.).
e82................... Rabbit epithelium...... Oryctolagus cuniculus
(Oryctolagus spp.).
e83................... Swine epithelium....... Sus scrofa
(Sus scrofa domesticus;
Sus spp.).
e84................... Hamster epithelium..... Cricetus cricetus,
Mesocricetus auratus,
and Phodopus sungorus.
e85................... Chicken feathers....... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e86................... Duck feathers.......... Anas platyrhynchos.
e87................... Rat epithelium, serum Rattus norvegicus
proteins, and urine Rattus rattus.
proteins.
e88................... Mouse epithelium, serum Mus musculus (Mus
proteins, and urine spp.).
proteins (mouse).
e89................... Turkey feathers........ Meleagris gallopavo.
e90................... Budgerigar serum Melopsittacus
proteins, feathers, undulatus.
and droppings.
e91................... Pigeon serum proteins, Streptopelia
feathers, and roseogrisea
droppings. Psittacidae spp.
e92................... Parrot serum proteins, Ara spp.
feathers, and
droppings.
e93................... Pigeon serum proteins.. Streptopelia
roseogrisea.
e94................... Fel d 1.0101........... Felis domesticus.
a345.................. Fel d 1................ Felis domesticus.
e98................... Parrot droppings....... Psittacoidea spp.
e101.................. Can f 1.0101........... Canis familiaris (Canis
domesticus).
a174.................. Can f 1................ Canis familiaris (Canis
domesticus).
e102.................. Can f 2.0101........... Canis familiaris (Canis
domesticus).
e196.................. Parakeet feathers...... Nymphicus hollandicus.
e197.................. Parakeet droppings..... Nymphicus hollandicus.
e198.................. Parakeet serum......... Nymphicus hollandicus.
e199.................. Canary bird serum...... Serinus canarius.
e200.................. Canary bird droppings.. Serinus canarius.
e201.................. Canary bird feathers Serinus canarius.
(Canary feathers).
e202.................. Reindeer epithelium.... Rangifer tarandus.
e203.................. Mink epithelium........ Mustela spp.
e204.................. Bos d 6................ Bos domesticus (Bos
taurus; Bos spp.).
e205.................. Horse, serum proteins.. Equus caballus (Equus
spp.).
e206.................. Rabbit, serum proteins. Oryctolagus cuniculus
(Oryctolagus spp.).
e208.................. Chinchilla epithelium.. Chinchilla laniger.
e209.................. Gerbil epithelium...... Meriones unguiculatus.
e210.................. Fox epithelium......... Vulpes vulpes.
e211.................. Rabbit, urine proteins. Oryctolagus cuniculus
(Oryctolagus spp.).
e212.................. Swine, urine proteins.. Sus scrofa
(Sus scrofa domesticus;
Sus spp.).
e213.................. Parrot feathers........ Ara spp.
e214.................. Finch feathers......... Lonchura domestica.
e215.................. Pigeon feathers........ Streptopelia
roseogrisea
(Streptopelia spp.)
Columbia spp.
e216.................. Deer epithelium........ Dama dama.
e217.................. Ferret epithelium...... Mustela putorius.
e218.................. Chicken droppings...... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e219.................. Chicken, serum proteins Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
e220.................. Fel d 2, Cat serum Felis domesticus.
albumin.
e221.................. Can f 3................ Canis familiaris (Canis
domesticus)
(Dog serum albumin).
e222.................. Swine serum albumin Sus scrofa (Sus scrofa
(Sus s PSA). domesticus; Sus spp.).
e225.................. Lovebird feathers...... Psittacoidea agapomis.
e226.................. Can f 5.0101........... Canis familiaris.
e227.................. Equ c 1.0101........... Equus caballus.
e228.................. Fel d 4.0101........... Felis domesticus.
e230.................. Equ c 3................ Equus caballus.
[[Page 31997]]
e231.................. Mus m 1................ Mus musculus.
------------------------------------------------------------------------
Food
------------------------------------------------------------------------
f9.................... Rice................... Oryza sativa.
f12................... Pea (green pea)........ Pisum sativum.
f15................... White bean............. Phaseolus vulgaris.
f19................... Cayenne pepper......... Capsicum frutescens
(Capsicum annum).
f21................... Sugar cane............. Saccharum officinarum.
f22................... Raspberry.............. Rubus idaeus.
f26................... Pork................... Sus scrofa (Sus scrofa
domesticus; Sus spp.).
f29................... Watermelon............. Citrullus lanatus
(Citrullus vulgaris).
f31................... Carrot................. Daucus carota.
f32................... Oyster mushroom........ Pleurotus ostreatus.
f33................... Orange................. Citrus sinensis.
f35................... Potato................. Solanum tuberosum.
f43................... Mother's milk.......... Homo sapiens.
f44................... Strawberry............. Fragaria vesca
(Fragaria spp.).
f45................... Yeast, baker's......... Saccharomyces
cerevisiae.
f46................... Pepper, Red............ Capsicum annuum.
f47................... Garlic................. Allium sativum.
f48................... Onion.................. Allium cepa.
f49................... Apple.................. Malus x domestica
(Malus spp.).
f51................... Bamboo shoot........... Phyllostachys
pubescens.
f52................... Cacao/chocolate........ Theobroma cacao.
f54................... Sweet potato........... Ipomoea batatas.
f55................... Common millet.......... Panicum miliaceum.
f56................... Foxtail millet......... Setaria italica.
f57................... Japanese millet........ Echinochloa crus-galli.
f58................... Pacific squid.......... Todarodes pacificus.
f59................... Octopus................ Octopus vulgaris
(Octopus spp.).
f63................... Kefir.................. NA.
f67................... Parmesan cheese........ NA.
f81................... Cheese, cheddar type... NA.
f82................... Cheese, mold type...... NA.
f83................... Chicken................ Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
f86................... Parsley................ Petroselinum crispum.
f87................... Melon.................. Cucumis melo Cucumis
melo + Citrullus
lanatus.
f88................... Mutton (lamb).......... Ovis aries (Ovis spp.).
f90................... Malt................... Hordeum vulgare.
f92................... Banana................. Musa spp.
f93................... Cacao.................. Theobroma cacao.
f94................... Pear................... Pyrus communis (Pyrus
spp.).
f97................... Yam.................... Dioscorea spp.
Dioscorea opposita.
f97................... Chamomile tea.......... Matricaria chamomilla.
f98................... Gliadin................ Triticum aestivum
(Triticum spp.).
f102.................. Cantaloupe............. Cucumis melo var.
cantalupensis.
f105.................. Chocolate.............. Theobroma cacao.
f109.................. Cottonseed............. Gossypium hirsutum.
f110.................. Giant radish........... Raphanus sativus.
f118.................. Zucchini............... Cucurbita pepo.
f119.................. Radish................. Raphanus sativus.
f120.................. Venison................ Capreolus capeolus.
f121.................. Pinto bean............. Phaseolus vulgaris.
f122.................. Cheese, American....... NA.
f127.................. Black-eyed pea......... Vigna unguiculata.
f131.................. Black Olive............ Olea europaea.
f136.................. Red beet............... Beta vulgaris var.
conditiva.
f139.................. Goat's Cheese.......... Capra aegagrus.
f140.................. Bran................... NA.
f141.................. Corn (vegetables)...... Zea mays.
f152.................. Green bell pepper...... Capsicum annuum.
f155.................. Brewer's yeast......... Saccharomyces
carlsbergensis.
f157.................. Duck................... Anas domesticus.
f158.................. Goose.................. Anser anser.
f160.................. Camembert cheese....... NA.
[[Page 31998]]
f162.................. Nectarine.............. Prunus persica var.
nucipersica.
f163.................. Kohlrabi............... Brassica oleracea var.
gongylodes.
f65................... Perch..................
f166.................. Leek................... Allium porrum.
f170.................. Cheese (Switzerland) NA.
(Swiss cheese).
f174.................. Fig.................... Ficus carica.
f177.................. Cranberry.............. Vaccinium macrocarpon.
f179.................. Raisin................. Vitis spp.
f182.................. Lima bean.............. Phaseolus lunatus.
f198.................. Flaxseed (bruised Linum usitatissimum.
grain).
f199.................. Untreated native milk.. Bos domesticus (Bos
taurus; Bos spp.).
f208.................. Lemon.................. Citrus limon.
f209.................. Grapefruit............. Citrus paradisi.
f210.................. Pineapple.............. Ananas comosus.
f211.................. Blackberry............. Rubus fruticosus.
f212.................. Mushroom (champignon).. Agaricus hortensis
(Agaricus spp.).
f213.................. Rabbit................. Oryctolagus cuniculus
(Oryctolagus spp.).
f214.................. Spinach................ Spinacia oleracea.
f215.................. Lettuce................ Lactuca sativa.
f216.................. Cabbage................ Brassica oleracea var.
capitata.
f217.................. Brussels sprouts....... Brassica oleracea var.
gem.
f218.................. Paprika, sweet pepper.. Capsicum annuum.
f219.................. Fennel seed............ Foeniculum vulgare.
f219.................. Sage................... Salvia officinalis.
f220.................. Cinnamon............... Cinnamomum spp.
f221.................. Coffee................. Coffea spp.
f222.................. Tea.................... Camellia sinensis.
f223.................. Green olive............ Olea europaea.
f225.................. Summer squash, pumpkin. Cucurbita pepo.
f225.................. Pumpkin................ Cucurbita maxima.
f226.................. Pumpkin seed........... Cucurbita pepo.
f227.................. Sugar-beet seed........ Beta vulgaris.
f229.................. Safflower Seed......... Carthamus tinctorius.
f231.................. Milk, boiled........... Bos domesticus
(Bos taurus; Bos spp.).
f234.................. Vanilla................ Vanilla planifolia.
f237.................. Apricot................ Prunus armeniaca.
f241.................. Gouda cheese........... NA.
f242.................. Cherry................. Prunus avium.
f244.................. Cucumber............... Cucumis sativus.
f246.................. Guar, guar gum......... Cyamopsis
tetragonoloba.
f247.................. Honey.................. NA.
f248.................. Rosemary............... Rosmarinus officinalis.
f254.................. Plaice................. Pleuronectes platessa.
f255.................. Plum................... Prunus domestica
Prunus americana.
f258.................. Squid.................. Loligo spp.
f259.................. Grape.................. Vitis vinifera
(Vitis spp.).
f260.................. Broccoli............... Brassica oleracea var.
italica (Brassica
oleracea var.
cultivar).
f261.................. Asparagus.............. Asparagus officinalis.
f262.................. Aubergine, eggplant.... Solanum melongena.
f263.................. Green pepper........... Piper nigrum
Capsicum annuum.
f264.................. Eel.................... Anguilla anguilla.
f265.................. Caraway................ Carum carvi.
f265.................. Cumin.................. Cuminum cyminum.
f266.................. Mace................... Myristica fragrans.
f267.................. Cardamon............... Elettaria cardamomum.
f268.................. Clove.................. Syzygium aromaticum.
f269.................. Basil.................. Ocimum basilicum.
f270.................. Ginger................. Zingiber officinale.
f271.................. Anise.................. Pimpinella anisum.
f272.................. Tarragon............... Artemisia dracunculus.
f273.................. Thyme.................. Thymus vulgaris.
f274.................. Marjoram............... Origanum majorana.
f275.................. Lovage................. Levisticum officinale.
f276.................. Fennel, fresh.......... Foeniculum vulgare.
[[Page 31999]]
f277.................. Dill................... Anethum graveolens.
f278.................. Bay leaf............... Laurus nobilis.
f279.................. Chili pepper........... Capsicum frutescens.
f280.................. Black pepper........... Piper nigrum.
f281.................. Curry (Santa Maria).... NA.
f282.................. Nutmeg................. Myristica fragrans.
f283.................. Oregano................ Origanum vulgare.
f284.................. Turkey meat............ Meleagris gallopavo.
f285.................. Elk/moose meat......... Alces spp.
f286.................. Mare's milk............ Equus caballus (Equus
spp.).
f287.................. Red kidney bean........ Phaseolus vulgaris.
f288.................. Blueberry.............. Vaccinium myrtillus
(Vaccinium spp.).
f289.................. Date................... Phoenix dactylifera.
f291.................. Cauliflower............ Brassica oleracea var.
botrytis.
f292.................. Guava.................. Psidium guajava.
f293.................. Papaya................. Carica papaya.
f294.................. Passion fruit, Maracuja Passiflora edulis
(Passiflora spp.).
f295.................. Carambola.............. Averrhoa carambola.
f296.................. Carob.................. Ceratonia siliqua.
f297.................. Gum arabic............. Acacia senegal (Acacia
spp.).
f298.................. Tragacanth............. Astragalus spp.
f299.................. Sweet chestnut Castanea sativa.
(chestnut).
f300.................. Pinto bean............. Phaseolus spp.
f301.................. Persimmon (kaki fruit, Diospyros kaki.
sharon).
f302.................. Mandarin (tangerine, Citrus reticulata.
clementine, satsumas).
f305.................. Fenugreek.............. Trigonella foenum-
graecum.
f306.................. Lime................... Citrus aurantifolia.
f307.................. Hake................... Merluccius merluccius.
f308.................. Sardine (pilchard)..... Sardina pilchardus.
f310.................. Blue vetch............. Lathyrus sativus.
f311.................. Megrim................. Lepidorhombus
whiffiagonis.
f315.................. Green bean............. Phaseolus vulgaris.
f316.................. Rape seed.............. Brassica napus.
f317.................. Coriander.............. Coriandrum sativum.
f318.................. Jack fruit............. Artocarpus
heterophyllus.
f319.................. Beetroot............... Beta vulgaris.
f320.................. Crayfish............... Astacus astacus.
f321.................. Horse meat............. Equus caballus (Equus
spp.).
f322.................. Red currant............ Ribes sylvestre.
f324.................. Hop (fruit cone)....... Humulus lupulus.
f325.................. Saffron................ Colchicum autumnale.
f328.................. Fig.................... Ficus carica.
f329.................. Watermelon............. Citrullus lanatus.
f330.................. Rose hip............... Rosa spp.
f331.................. Saffron................ Crocus sativus.
f332.................. Mint................... Mentha piperita.
f333.................. Linseed................ Linum usitatissimum.
f336.................. Jujube................. Ziziphus jujuba.
f336.................. Wine vinegar........... Vitis vinifera (Vitis
spp.).
f337.................. Sole................... Solea solea.
f337.................. English sole........... Parophrys vetulus.
f338.................. Wine, white............ Vitis vinifera (Vitis
spp.).
f339.................. Allspice............... Pimenta dioica.
f339.................. Wine, red.............. Vitis vinifera (Vitis
spp.).
f341.................. Cranberry.............. Vaccinium oxycoccus
Vaccinium macrocarpon.
f342.................. Olive (black, fresh)... Olea europaea.
f343.................. Raspberry.............. Rubus idaeus.
f344.................. Sage................... Salvia officinalis.
f346.................. Chives................. Allium schoenoprasum.
f347.................. Quinoa................. Chenopodium quinoa.
f348.................. Litchi................. Litchi chinensis.
f349.................. Chum salmon roe........ Oncorhynchus keta.
f358.................. Artichoke.............. Cynara scolymus.
f360.................. Yogurt................. NA.
f368.................. Black bass............. Micropterus dolomieu
(Micropterus
dolomieui).
f374.................. Karaya gum............. Sterculia urens.
f375.................. Horseradish............ Armoracia rusticana.
f377.................. Maple syrup............ NA.
f379.................. Okra................... Abelmoschus esculentus.
[[Page 32000]]
f382.................. Beet, sugar............ Beta vulgaris var.
altissima.
f401.................. Loquat................. Eriobotrya japonica.
f402.................. Fig.................... Ficus carica.
f403.................. Brewer's yeast......... Saccharomyces
cerevisiae.
f405.................. Mint................... Mentha spp.
f406.................. Arugula................ Eruca vesicaria.
------------------------------------------------------------------------
House Dust
------------------------------------------------------------------------
h1.................... Greer Labs., Inc....... NA.
h2.................... Hollister-Stier Labs... NA.
h6.................... Japan.................. NA.
------------------------------------------------------------------------
Venoms & Insects
------------------------------------------------------------------------
i7.................... Midge.................. Chironomus yoshimatsui.
i8.................... Moth................... Bombyx mori
Heterocera spp.
i47................... Water flea............. Daphnia spp.
i49................... Deer fly............... Chrysops spp.
i51................... Black ant.............. Camponotus
pennsylvanicus.
i54................... Flea mix (dog/cat), Ctenocephalides spp.
common flea.
i71................... Mosquito............... Aedes communis
Aedes spp. and Culex
spp.
i72................... Green nimitti.......... Cladotanytarsus lewisi.
i73................... Blood worm............. Chironomus thummi
Chironomusri parius
Chironomus spp.
i75................... European hornet........ Vespa crabro.
i76................... Berlin beetle.......... Trogoderma angustum.
i77................... European paper wasp.... Polistes dominulus.
i78................... Fly.................... Musca domestica.
i80................... Bumblebee.............. Bombus pennsylvanicus.
i201.................. Horse bot fly.......... Gasterophilus
intestinalis.
i202.................. Grain weevil........... Sitophilus granarius.
i203.................. Mediterranean flour Ephestia kuehniella
moth. (Anagasta kuehniella).
i204.................. Horse fly.............. Tabanus spp.
i205.................. Bumblebee.............. Bombus terrestris.
i208.................. Api m 1.0101........... Apis mellifera.
a45................... Api m 1................ Apis mellifera.
i209.................. Ves v 5.0101........... Vespula vulgaris.
a670.................. Ves v 5................ Vespula vulgaris.
i210.................. Pol d 5.0101........... Polistes dominulus.
i211.................. Ves v 1.0101........... Vespula vulgaris.
i213.................. Api m 4................ Apis mellifera.
i214.................. Api m 2................ Apis mellifera.
i215.................. Api m 3................ Apis mellifera.
i216.................. Api m 5................ Apis mellifera.
i217.................. Api m 10............... Apis mellifera.
i220.................. Bla g 1.0101........... Blattella germanica.
i221.................. Bla g 2.0101........... Blattella germanica.
i222.................. Bla g 5.0101........... Blattella germanica.
i223.................. Bla g 7................ Blattella germanica
a46................... Api m 2................ Apis mellifera.
------------------------------------------------------------------------
Miscellaneous
------------------------------------------------------------------------
o1.................... Cotton, crude fibers... Gossypium spp.
o3.................... Cotton (treated)....... Gossypium spp.
o70................... Seminal fluid.......... Homo sapiens.
o71................... Staphylococcus aureus.. Staphylococcus aureus.
o72................... Pichia pastoris crude Pichia pastoris.
extract customer
specific.
o72................... Sperm-sediment......... Homo sapiens.
o73................... Pichia pastoris crude Pichia pastoris.
extr. vector customer
specific.
o74................... Pichia pastoris with Pichia pastoris.
vector customer
specific.
o201.................. Tobacco leaf, tobacco Nicotiana tabacum.
dust.
o202.................. Artemia salina, fish Artemia salina.
feed.
o203.................. Tetramin, fish feed.... NA.
o207.................. Daphnia, fish feed..... Daphnia spp.
o211.................. Mealworm............... Tenebrio molitor.
[[Page 32001]]
o212.................. Streptavidin........... Streptomyces avidini.
o213.................. MBP (maltose binding Escherichia coli.
protein).
o214.................. CCD; MUXF3 from Ananas comosus.
bromelain.
o72................... Enterotoxin A (Sta a Staphylococcus aureus.
SEA).
o73................... Enterotoxin B (Sta a Staphylococcus aureus.
SEB).
------------------------------------------------------------------------
Parasites
------------------------------------------------------------------------
p1.................... Ascaris................ Ascaris suum.
p2.................... Echinococcus........... Echinococcus
granulosus.
p3.................... Schistosoma............ Schistosoma mansoni.
p4.................... Anisakis (Herring Worm) Anisakis simplex
(Anisakis spp.).
p5.................... Toxocara canis......... Toxocara canis.
p10................... Ani s 3.0101........... Anisakis simplex
(Anisakis spp.).
p11................... Ani s 1................ Anisakis simplex
(Anisakis spp.).
------------------------------------------------------------------------
Occupational
------------------------------------------------------------------------
k4.................... Threshing dust......... NA.
k5.................... Flax................... NA.
k7.................... Hay Dust............... NA.
k8.................... Hop (hops)............. Humulus lupulus.
k12................... Grain mill dust........ NA.
k14................... Kapok.................. NA.
k20................... Sheep's wool (treated) Ovis aries (Ovis spp.).
(wool).
k21................... Sheep's wool Ovis aries (Ovis spp.).
(Untreated).
k23................... Straw Dust............. NA.
k33................... Oak.................... NA.
k70................... Green coffee bean...... Coffea spp.
k71................... Castor bean............ Ricinus communis.
k72................... Ispaghula.............. Plantago psyllium/
Plantago ovata.
k73................... Silk waste............. NA.
k74................... Silk................... Bombyx mori.
k75................... Isocyanate TDI (Toluene NA.
diisocyanate).
k76................... Isocyanate MDI NA.
(Diphenylmethane
diisocyanate).
k77................... Isocyanate HDI NA.
(Hexamethylen
diisocyanate).
k78................... Ethylene oxide......... NA.
k79................... Phthalic anhydride..... NA.
k80................... Formaldehyde/Formalin.. NA.
k81................... Ficus.................. Ficus benjamina (Ficus
spp.).
k83................... Cotton seed............ Gossypium hirsutum.
k84................... Sunflower seed......... Helianthus annuus.
k85................... Chloramin T............ NA.
k86................... Trimellitic anhydride, NA.
TMA.
k87................... Asp o 21, alpha-amylase Aspergillus oryzae.
k89................... Orris root............. Iris florentina.
k99................... HSA (Human Serum Homo sapiens.
Albumin) (Hom s HSA).
k201.................. Car p 1, Papain........ Carica papaya.
k202.................. Ana c 2, Bromelain..... Ananas comosus.
k204.................. Maxatase............... Bacillus licheniformis.
k205.................. Alcalase............... Bacillus spp.
k206.................. Savinase, Protease 1 Bacillus spp.
(Bac l Subtilisin).
k208.................. Gal d 4, Lysozyme...... Gallus domesticus
(Gallus gallus
domesticus; Gallus
spp.).
k209.................. Hexahydrophtalic NA.
anhydrid.
k210.................. Maleic anhydride....... NA.
k211.................. Methyltetrahydrophtalic NA.
anhydrid.
k212.................. Abachi wood dust....... Triplochiton
scleroxylon.
k213.................. Pepsin (Sus s Pepsin).. Sus scrofa (Sus scrofa
domesticus; Sus spp.).
k213.................. TCPA................... NA.
k214.................. Bougainvillea.......... Bougainvillea spp.
k225.................. Horse radish peroxidase Armoracia rusticana.
(Arm r HRP).
k226.................. Ascorbate oxidase (Cuc Cucurbita pepo.
p ascorbate oxidase).
k301.................. Flour dust............. Triticum spp.
k501.................. Savinase customer Proprietary knowledge
specific. of customer.
k502.................. Lipolase customer Proprietary knowledge
specific. of customer.
k503.................. Termamyl customer Proprietary knowledge
specific. of customer.
k504.................. Clazinase customer Proprietary knowledge
specific. of customer.
------------------------------------------------------------------------
[[Page 32002]]
V. Reference
The following reference is on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
1. FDA Guidance, ``Procedures for Class II Device Exemptions From
Premarket Notification, Guidance for Industry and CDRH Staff,''
February 19, 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf.
Dated: July 5, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-14453 Filed 7-10-17; 8:45 am]
BILLING CODE 4164-01-P