# K040466: Bindazyme Human Anti Tissue Transglutaminase Iga and Igg Eia Diagnostic Test Kits

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site
- Decided: Jul 16, 2004 after 144 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This assay is designed for the in-vitro measurement of specific IgG autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease. This assay is designed for the in-vitro measurement of specific IgA autoantibodies against tissue transglutaminase (tTG) present in human serum, as an aid in the diagnosis of Coeliac disease.

Source page: https://510kreport.com/device/K040466
Methodology: https://510kreport.com/methodology