# K042760: Pefakit Apc-R Factor V Leiden Controls

- Pathway: 510(k) (Abbreviated)
- Applicant: Pentapharm, Ltd.
- Decided: Dec 22, 2004 after 78 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: 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 1.

## Indications for use
The device is a box containing lyophilized pooled plasmas from donors genotyped for the factor V Leiden mutation (FV: Q506) to be reconstituted with water by the user. Controls contain pooled plasmas of either donors with heterozygous FV:Q506 mutation or normal wild-type pattern. These controls are intended to be used for quality assurance in connection with the IVD device 'Pefakit® APC-R Factor V Leiden'.

Source page: https://510kreport.com/device/K042760
Methodology: https://510kreport.com/methodology