# K062430: Hemosil Protein C

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory CO
- Decided: Sep 1, 2006 after 11 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: 2 generations back to K922201 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980875: IL Test Protein C, Instrumentation Laboratory CO (1998) Summary page 1.

## Indications for use
HemosIL Protein C is an in vitro diagnostic test for the quantitative determination of Protein C in human citrated plasma based on a synthetic chromogenic substrate. Protein C deficiency is associated with recurrent venous thrombosis, especially in young adults. Acquired deficiencies of Protein C are associated with hepatic disorders, oral anticoagulant therapy and disseminated intravascular coagulation.

Source page: https://510kreport.com/device/K062430
Methodology: https://510kreport.com/methodology