# K083052: Euroimmun Anti-Gliadin (Gaf-3X) Elisa (Iga)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Jul 28, 2009 after 287 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.
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
The Anti-Gliadin (GAF-3X) ELISA (IgA) test kit is intended for the qualitative or semi-quantitative determination of IgA class antibodies against gliadin in human serum. It is used as an aid in the diagnosis of gluten-sensitive enteropathy (celiac disease) and dermatitis herpetiformis Duhring, in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K083052
Methodology: https://510kreport.com/methodology