# K062840: Triage Protein C Controls and Calibration Verification Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Mar 1, 2007 after 160 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000121 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000230: Triage B-Type Natriuretic Peptide (BNP) Controls, Biosite Incorporated (2000) Summary page 1.
- K050029: Cardiompo Test, Prognostix, Inc. (2005) Summary page 1.

## Indications for use
The Triage Protein C Controls are assayed materials to be used with the Triage Protein C Test to assist the laboratory in monitoring test performance. The Triage Protein C Calibration Verification Controls may be used by the laboratory to validate the performance of the Triage Protein C Test throughout the measurable range of the assay.

Source page: https://510kreport.com/device/K062840
Methodology: https://510kreport.com/methodology