# K990207: Gliadin Iga Elisa Test System

- Pathway: 510(k) (Traditional)
- Applicant: Zeus Scientific, Inc.
- Decided: Mar 26, 1999 after 64 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 Zeus Scientific, Inc. Gliadin IgA ELISA test system is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. The test system is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Coeliac Disease. This test is for in vitro diagnostic use.

Source page: https://510kreport.com/device/K990207
Methodology: https://510kreport.com/methodology