# K030555: GPS Platelet Separation Kit with Anticoagulant Acd-a

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 11, 2003 after 49 days
- Product code: JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003286 (2001). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021927: Platelet Concentrate Separation Kit for Celsep Centrifuge System, Biomet, Inc. (2002)
- K021071: PCCS Graft Delivery System, Biomet, Inc. (2002)

## Indications for use
The GPSm Platelet Separation kit is designed for use in the clinical laboratory or intra-operatively at point of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60 ml) of whole blood. The plasma and concentrated platelets can be used for diagnostic tests.

Source page: https://510kreport.com/device/K030555
Methodology: https://510kreport.com/methodology