# K972627: Pacific Hemostasis Immunodepleted Factor V Deficient Plasma (Thrombosdreen Brand) (100056)

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Aug 13, 1997 after 30 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 K912679 (1991). 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)
- K912679: Dade (R) Immunoadsorbed Fact V Def Plasma (Human), Baxter Healthcare Corp (1991) Summary page 1.

## Indications for use
Pacific Hemostasis Immunodepleted Factor V Deficient Plasma is intended for use in the quantitative determination of Factor V activity in patient plasma. Factor V activity in plasma is assayed by the amount of Prothrombin Time correction produced by the test plasma when mixed with factor deficient plasma. The correction of the unknown is compared to that produced by a reference plasma of known normal activity.

Source page: https://510kreport.com/device/K972627
Methodology: https://510kreport.com/methodology