# K981173: Cryo Check Factor XI Deficient Plasma, Model FDP11-10 (1.Oml) and FDP11-15 (1.5ML)

- Pathway: 510(k) (Traditional)
- Applicant: Precision Biologicals, Inc.
- Decided: Jan 13, 1999 after 287 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
Longest line of descent: 1 generation back to K900411 (1990). 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)
- K900411: Factor XI Deficient Plasma, Sigma Chemical Co. (1990) Summary page 2.

## Indications for use
Deficiencies in coagulation factors may have congenital or acquired etiologies and can compromise in vivo hemostasis. Factor XII (also known as Hageman factor) is a serine protease located in the “intrinsic coagulation pathway”. Patients with Factor XII deficiency generally do not have significant bleeding tendencies. Factor XII deficiency is commonly diagnosed in vitro through the use of the activated partial thromboplastin time (APTT). Cryov'Check™ Factor XII Deficient Plasma is human plasma deficient in the Factor XII coagulation protein while having all other coagulation factors greater than 50%. It is recommended for use as a substrate in clot-based Factor XII assays using the activated partial thromboplastin time (APTT).

Source page: https://510kreport.com/device/K981173
Methodology: https://510kreport.com/methodology