# K993553: Gti-Fviii Inhibitor Assay

- Pathway: 510(k) (Traditional)
- Applicant: Genetic Testing Institute
- Decided: Feb 1, 2000 after 104 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Gti-PF4 Elisa: named in the summary without a submission number

## Most influential descendants
- K082205: Factor Viii Antibody Screen (2008), 1 descendant of its own
- K183440: CRYOcheck FVIII Inhibitor Kit (2019), 0 descendants of its own

## Indications for use
GTI-FVII Inhibitor Assay is designed as a solid phase Enzyme-Linked Immunosorbent Assay (ELISA). The product is intended to be used as an in vitro diagnostic kit by hemostasis and other laboratories providing factor VIII inhibitor assay to assist in screening samples for the presence of alloantibodies to epitopes on FVIII molecule.

Source page: https://510kreport.com/device/K993553
Methodology: https://510kreport.com/methodology