# K062530: Triage Protein C Test

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jan 29, 2007 after 153 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 K854016 (1986). 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)
- K854016: Asserachrom Protein C Kit, American Bioproducts Co. (1986) Summary page 1.

## Indications for use
The Triage Protein C Test is a rapid, point-of-care fluorescence immunoassay to be used with the Triage Meters for the rapid, quantitative determination of Protein C in citrated whole blood or plasma specimens in patients with signs and symptoms of sepsis. The test is not intended for use in patients with vitamin K deficiency, DIC, cancers, HIV and liver and renal diseases as these disease conditions have not been evaluated.

Source page: https://510kreport.com/device/K062530
Methodology: https://510kreport.com/methodology