# K051054: Visulize Factor IX Antigen Kit

- Pathway: 510(k) (Traditional)
- Applicant: Affinity Biologicals, Inc.
- Decided: Jun 29, 2005 after 64 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: 1 generation back to K854312 (1986). 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)
- K854312: Asserachrom IX:AG, American Bioproducts Co. (1986) Summary page 1.

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

Source page: https://510kreport.com/device/K051054
Methodology: https://510kreport.com/methodology