# K012797: Diamedix IS-Anti-Gliadin Iga Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Sep 28, 2001 after 38 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. The FDA summary names its predicate without a number.
- (no number) Inova QUANTA Lite Gliadin IgA ELISA: named in the summary without a submission number

## Indications for use
The Diamedix Is anti-Gliadin IgA Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgA antibodies to gliadin in human serum as an aid in the diagnosis of celiac disease. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.

Source page: https://510kreport.com/device/K012797
Methodology: https://510kreport.com/methodology