# K971222: Cryo Check Apc Resistant Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologicals, Inc.
- Decided: Aug 19, 1997 after 139 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Activated protein C (APC) is a serine protease with potent anticoagulant properties. During normal hemostasis, APC hinders clot formation through a mechanism of proteolytic inactivation of factors Va and Villa. Recently, a genetic single point mutation in the APC binding domain of the factor V gene, replacing Arg506 with Gln, was demonstrated to be both inherited and associated with familial thrombophilia. The resulting resistance of factor Va to activated protein C (APCR), often referred to as the factor V4., mutation, is now recognized as a commonly inherited risk factor for venous thrombosis. CryoCheck APC Resistant Plasma is indicated for use as a positive control in the clot based assessment of activated protein C resistance in citrated human plasma.

Source page: https://510kreport.com/device/K971222
Methodology: https://510kreport.com/methodology