# K102908: Nofact IX

- Pathway: 510(k) (Traditional)
- Applicant: R2 Diagnostics, Inc.
- Decided: Dec 19, 2011 after 444 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 K933432 (1993). 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)
- K933432: Stago Factor IX-Deficient Plasma, American Bioproducts Co. (1993) Summary page 1.

## Indications for use
NoFact IXDeficient Plasma is a human plasma immunodepleted of Factor IXand intended for the quantitative determination of Factor IX activity in citrated plasma from patients suspected of FIX deficiency. FIX activity is based on the activated partial thromboplastin time. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K102908
Methodology: https://510kreport.com/methodology