# K972288: Factor Deficient Plasmas - Factor IX (9)

- Pathway: 510(k) (Traditional)
- Applicant: Universal Reagents, Inc.
- Decided: Jul 14, 1997 after 25 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- 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
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, IX. Factor immunodeficient-plasma IX is made from human plasma that has been artificially depleted. This plasma has normal levels of all other factors. Claims - Negative per FDA approved test for HIV 1/2, HBSAG, HCV, HIV-1ag Packaging - Frozen Freeze dried - Lyophilized

Source page: https://510kreport.com/device/K972288
Methodology: https://510kreport.com/methodology