# K102851: Nofact Viii

- Pathway: 510(k) (Traditional)
- Applicant: R2 Diagnostics, Inc.
- Decided: Dec 19, 2011 after 446 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 K892859 (1989). 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)
- K892859: The Stago Viii Deficient Plasma Kit, American Bioproducts Co. (1989) Summary page 1.

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

Source page: https://510kreport.com/device/K102851
Methodology: https://510kreport.com/methodology