# K060157: Immuglo Anti-Endomysial Antibody Ifa

- Pathway: 510(k) (Traditional)
- Applicant: Immco Diagnostics, Inc.
- Decided: May 25, 2006 after 125 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 indirect immunofluorescence assay (IFA) for the detection of and semi-quantitation of endomysial antibodies (EMA) in human serum to aid in the diagnosis of Celiac Disease (CD) and Dermatitis Herpetiformis (DH) in combination with other clinical and other laboratory findings.

Source page: https://510kreport.com/device/K060157
Methodology: https://510kreport.com/methodology