# K082205: Factor Viii Antibody Screen

- Pathway: 510(k) (Traditional)
- Applicant: Genetic Testing Institute
- Decided: Nov 20, 2008 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: 1 generation back to K993553 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993553: Gti-Fviii Inhibitor Assay, Genetic Testing Institute (2000) Summary page 1.

## Most influential descendants
- K183440: CRYOcheck FVIII Inhibitor Kit (2019), 0 descendants of its own

## Indications for use
The Factor VIII Antibody Screen is designed as a solid phase enzyme-linked immunosorbent assay (ELISA) with a colorimetric endpoint. This product is intended to be used as an in vitro diagnostic kit by hemostasis and other laboratories to screen patient samples for the presence of IgG antibodies reactive with human Factor VIII.

Source page: https://510kreport.com/device/K082205
Methodology: https://510kreport.com/methodology