# K040095: Immulisa Anti-Human Tissue Transglutaminase (HU-TTG) Antibody Total Iga/Igg Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Mar 5, 2004 after 45 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
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of anti-human Tissue Transglutaminase IgG antibodies in human serum to aid in the diagnosis of celiac disease (CD) in patients with IgA deficiency. An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgA and IgG antibodies to human tissue transglutaminase, as an aid in diagnosis of Celiac Disease (CD).

Source page: https://510kreport.com/device/K040095
Methodology: https://510kreport.com/methodology