# K971226: Cryo Check Factor IX Deficient Plasma

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologicals, Inc.
- Decided: Jul 18, 1997 after 107 days
- Product code: GJT (Plasma, Coagulation Factor Deficient)
- 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
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
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor IX is a single chain protein with a molecular weight of 54,000 and is necessary for intrinsic coagulation. Factor IX deficiency (hemophilia B) is commonly diagnosed in vitro through the used of a modified activated partial thromboplastin time (APTT) assay. When a patient sample is mixed with factor IX deficient plasma, the degree of correction of the APTT is proportional to the level of Factor IX in the patient plasma. CryoCheck Factor IX Deficient Plasma is human plasma deficient in the factor IX coagulation protein while having all other coagulation factors within normal limits. it is indicated for use to assess factor IX deficiencies in in vitro clot-based factor IX assays using the activated partial thromboplastin time.

Source page: https://510kreport.com/device/K971226
Methodology: https://510kreport.com/methodology