# K060284: Cryocheck Clot Apcr

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologic, Inc.
- Decided: May 10, 2006 after 96 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: 1 generation back to K992456 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992456: Gradileiden V Test, Gradipore, Ltd. (1999) Summary page 1.

## Indications for use
CRYocheck Clot APCR is a clotting assay intended to screen for resistance to activated protein C in citrated human plasma from individuals with the factor VLeiden mutation.

Source page: https://510kreport.com/device/K060284
Methodology: https://510kreport.com/methodology