[Federal Register Volume 61, Number 131 (Monday, July 8, 1996)]
[Notices]
[Pages 35771-35772]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-17235]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96M-0218]
Adeza Biomedical Corp.; Premarket Approval of Fetal Fibronectin
Enzyme Immunoassay Kit
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing its
approval of the application by Adeza Biomedical Corp., Sunnyvale, CA,
for premarket approval, under the Federal Food, Drug, and Cosmetic Act
(the act), of Fetal Fibronectin Enzyme Immunoassay Kit. After reviewing
the recommendation of the Clinical Chemistry and Clinical Toxicology
Devices Panel, FDA's Center for Devices and Radiological Health (CDRH)
notified the applicant, by letter of September 29, 1995, of the
approval of the application.
DATES: Petitions for administrative review by August 7, 1996.
ADDRESSES: Written requests for copies of the summary of safety and
effectiveness data and petitions for administrative review to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Cornelia B. Rooks, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-1243.
SUPPLEMENTARY INFORMATION: On October 31, 1994, Adeza Biomedical Corp.,
Sunnyvale, CA 94089, submitted to CDRH an application for premarket
approval of Fetal Fibronectin Enzyme Immunoassay Kit. The device is to
be used as an aid in assessing the risk of preterm delivery in
ls-thn-eq 7 days or ls-thn-eq 14 days from the time of sample
collection in pregnant women with signs and symptoms of early preterm
labor, intact amniotic membranes, and minimal cervical dilatation (< 3
centimeters), sampled between 24 weeks, 0 days and 34 weeks, 6 days
gestation.
The negative predictive values of 99.5 percent and 99.2 percent,
for delivery in ls-thn-eq 7 and ls-thn-eq 14 days
respectively, make it highly likely that delivery will not occur in
these timeframes. In addition, although the positive predictive values
were found to be 12.7 percent and 16.7 percent for delivery in
ls-thn-eq 7 and ls-thn-eq 14 days, respectively, this
represents an approximate 4-fold increase over the reliability of
predicting delivery given no test information.
On April 6, 1995, the Clinical Chemistry and Clinical Toxicology
Devices Panel of the Medical Devices Advisory Committee, an FDA
advisory committee, reviewed and recommended approval of the
application.
On September 29, 1995, CDRH approved the application by a letter to
[[Page 35772]]
the applicant from the Director of the office of Device Evaluation,
CDRH.
A summary of the safety and effectiveness data on which CDRH based
its approval is on file in the Dockets Management Branch (address
above) and is available from that office upon written request. Requests
should be identified with the name of the device and the docket number
found in brackets in the heading of this document.
Opportunity for Administrative Review
Section 515(d)(3) of the act (21 U.S.C. 360e(d)(3)) authorizes any
interested person to petition, under section 515(g) of the act, for
administrative review of CDRH's decision to approve this application. A
petitioner may request either a formal hearing under part 12 (21 CFR
part 12) of FDA's administrative practices and regulations or a review
of the application and CDRH's action by an independent advisory
committee of experts. A petition is to be in the form of a petition for
reconsideration under Sec. 10.33(b) (21 CFR 10.33(b)). A petitioner
shall identify the form of review requested (hearing or independent
advisory committee) and shall submit with the petition supporting data
and information showing that there is a genuine and substantial issue
of material fact for resolution through administrative review. After
reviewing the petition, FDA will decide whether to grant or deny the
petition and will publish a notice of its decision in the Federal
Register. If FDA grants the petition, the notice will state the issue
to be reviewed, the form of the review to be used, the persons who may
participate in the review, the time and place where the review will
occur, and other details.
Petitioners may, at any time on or before August 7, 1996, file with
the Dockets Management Branch (address above) two copies of each
petition and supporting data and information, identified with the name
of the device and the docket number found in brackets in the heading of
this document. Received petitions may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (secs. 515(d), 520(h) (21 U.S.C. 360e(d), 360j(h))) and under
authority delegated to the Commissioner of Food and Drugs (21 CFR 5.10)
and redelegated to the Director, Center for Devices and Radiological
Health (21 CFR 5.53).
Dated: June 21, 1996.
Joesph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 96-17235 Filed 7-5-96; 8:45 am]
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