# K052825: Visulize Factor Viii Antigen Kit, Model Fviii-AG

- Pathway: 510(k) (Traditional)
- Applicant: Affinity Biologicals, Inc.
- Decided: Jan 20, 2006 after 107 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
Longest line of descent: 2 generations back to K833892 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981038: Coamatic Factor Viii, Instrumentation Laboratory CO (1998) Summary page 1.

## Indications for use
The VisuLize TM Factor VIII Antigen Kit is intended for use as an in vitro diagnostic assay for the quantitative determination of Factor VIII antigen in human plasma samples and Factor VIII concentrates using the double antibody enzyme linked immuno-sorbent assay (ELISA).

Source page: https://510kreport.com/device/K052825
Methodology: https://510kreport.com/methodology