# K123713: Immulisa Enhanced Celiac Fusion (TTG/DGP) Iga/Igg Antibody Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Oct 25, 2013 after 325 days
- Product code: MVM (Autoantibodies, Endomysial(Tissue Transglutaminase))
- Device class: 2
- Regulation: 21 CFR 866.5660
- 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 immunoassay (ELISA) for the qualitative or semi-quantitative detection of IgA and IgG antibodies to synthetic human tissue transglutaminase (tTG) and deaniidated gliadin peptide (DOP) in human serum to aid in the diagnosis of celiac disease (CD) in conjunction with other laboratory tests and clinical findings.

Source page: https://510kreport.com/device/K123713
Methodology: https://510kreport.com/methodology