# K973910: Gliadin Antibodies Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Diagnostics, Ltd.
- Decided: Feb 17, 1999 after 491 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 gliadin antibodies enzyme immunoassay system is used for the detection and semi-quantitative measurement of (IgG and IgA) antibodies to wheat gliadin in human serum. The test results obtained with the test kit are used as an aid in the diagnosis of gluten sensitive enteropathies such as celiac disease and dermatitis herpetiformis in children and adult patients.

Source page: https://510kreport.com/device/K973910
Methodology: https://510kreport.com/methodology