# K980875: IL Test Protein C

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Apr 21, 1998 after 46 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 K922201 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922201: Coamate Protein C Chromogenic Assay, Chromogenix AB (1992) Summary page 1.

## Most influential descendants
- K062430: Hemosil Protein C (2006), 0 descendants of its own

## Indications for use
IL Test™ 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/K980875
Methodology: https://510kreport.com/methodology