# K091522: Immulisa Celiac G+ (Gliadin) Iga and Igg Antibody Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Feb 4, 2010 after 258 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
Enzyme linked immunosorbent assay (ELISA) for the qualitative and semi-quantitative detection of IgA or IgG antibodies to gliadin in human serum to aid in the diagnosis of celiac disease in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K091522
Methodology: https://510kreport.com/methodology