# K981929: Bindazyme Antigliadin Igg/Iga Combi Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Sep 3, 1998 after 118 days
- Product code: MST (Antibodies, Gliadin)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K041002: Fidis Celiac (2004), 0 descendants of its own

## Indications for use
This assay is designed for the in-vitro measurement of specific IgA antibodies present in human serum against gliadin, as an 2id in the diagnosis of celiac disease. When sold in combination these assays are designed for the in-vitro measurement of specific Ig9G and IgA antibodies present in human serum against gliadin, as an aid in the diagnosis of celiac disease.

Source page: https://510kreport.com/device/K981929
Methodology: https://510kreport.com/methodology