# K260551: HemosIL Factor V Leiden (APC Resistance V)

- Pathway: 510(k) (Special)
- Applicant: Instrumentation Laboratory (IL) Co.
- Decided: Mar 20, 2026 after 30 days
- Product code: GGW (Test, Time, Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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 K945940 (1995). 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)
- K963111: Coatest Apc (TM) Resistance V/Coatest Apc (TM) Resistance V S, Chromogenix AB (1996) Summary page 5.

## Indications for use
For determination of resistance to activated Protein C, caused by the Factor V:Q506 (Factor V Leiden) mutation, in plasma from untreated individuals and from patients on oral anti-coagulant (OAT) or heparin therapy.

Source page: https://510kreport.com/device/K260551
Methodology: https://510kreport.com/methodology