# K022290: Protein S AC

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Aug 27, 2002 after 43 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913424 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913424: Staclot (R) Protein S Test Kit, American Bioproducts Co. (1991) Summary page 1.

## Indications for use
Reagent for the quantitative determination of the functional activity of protein S in human plasma.

Source page: https://510kreport.com/device/K022290
Methodology: https://510kreport.com/methodology