# K032571: Immulisa Anti-Human Tissue Transglutaminase (HU-TTG) Antibody Iga Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: Dec 24, 2003 after 126 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 IgA antibodies to human tissue transglutaminase, as an aid in diagnosing patients with Gluten Sensitive Enteropathy (celiac Disease and Dematitis herpetiform-is)

Source page: https://510kreport.com/device/K032571
Methodology: https://510kreport.com/methodology