# K012795: Diamedix IS-Anti-Gliadin Igg 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: 1 (0 Class I)
- 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 IgG ELISA: named in the summary without a submission number

## Recalls of this device
- Mar 21, 2008 · Not classified · Z-1684-2008: Standards and controls in the Is-anti-Gliadin IgG Test Kits are exhibiting low activity. A drop in the O.D.s the Positive Control could potentially recover low out of range (which would invalidate the

## Indications for use
The Diamedix Is anti-Gliadin IgG Test Kit is an indirect enzyme immunoassay (EIA) for the semi-quantitative measurement of IgG 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/K012795
Methodology: https://510kreport.com/methodology