# K163177: ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISA

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Jul 28, 2017 after 256 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) IMMCO Gliadin (AGA) IgA ELISA: named in the summary without a submission number
- (no number) IMMCO Gliadin (AGA) IgG ELISA: named in the summary without a submission number

## Indications for use
Enzyme linked immunosorbent assays (ELISA) for the qualitative or semi-quantitative detection of IgA anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings Enzyme linked immunosorbent assays (ELISA) for the qualitative or semi-quantitative detection of IgG anti-gliadin antibodies in human serum to aid in the diagnosis of patients with celiac disease or dermatitis herpetiformis in conjunction with other laboratory and clinical findings

Source page: https://510kreport.com/device/K163177
Methodology: https://510kreport.com/methodology