(a) Identification. An automated blood cell separator is a device that automatically removes whole blood from a donor, separates the blood into components (red blood cells, white blood cells, plasma, and platelets), retains one or more of the components, and returns the remainder of the blood to the donor. The components obtained are transfused or used to prepare blood products for administration. These devices operate on either a centrifugal separation principle or a filtration principle. The separation bowls of centrifugal blood cell separators may be reusable or disposable.

(b) Classification. Class III (premarket approval).

(c) Date PMA or notice of completion of a PDP is required. No effective date has been established of the requirement for premarket approval. See § 864.3.