# K972286: Factor Deficient Plasmas - Factor XI (11)

- Pathway: 510(k) (Traditional)
- Applicant: Universal Reagents, Inc.
- Decided: Jul 14, 1997 after 25 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. The FDA summary names its predicate without a number.
- (no number) Pacific Hemostasis Factor XI: named in the summary without a submission number

## Indications for use
Indicated use - This product is intended for use in the quantitative determination of factor levels in patients suspected of congenital or acquired deficiency of this coagulation protein or factor, XI. Factor immunodeficient plasma XI is made from human plasma that has been artificially depleted. This plasma has normal levels of all.other factors. Claims - Negative per FDA ap’éroved tsst for HIV 1/2, HBsSAG, HCV, HIV-1ag - Packaging - Frozen Freeze dried - Lyophilized

Source page: https://510kreport.com/device/K972286
Methodology: https://510kreport.com/methodology