# K092736: Euroimmun Anti-M2-3E Elisa (Igg)

- Pathway: 510(k) (Traditional)
- Applicant: Euroimmun Us, Inc.
- Decided: Sep 2, 2010 after 363 days
- Product code: DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K052262 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052262: Quanta Lite M2 EP (MIT3) Elisa, Inova Diagnostics, Inc. (2005) Summary page 2.

## Indications for use
The EUROIMMUN Anti-M2-3E ELISA (IgG) test kit is intended for the qualitative or semi-quantitative determination of lgG class autoantibodies against the mitochondrial antigens M2 in human serum and plasma. It is used as an aid in the diagnosis of primary biliary cirrhosis (PBC), in conjunction with other laboratory and clinical findings.

Source page: https://510kreport.com/device/K092736
Methodology: https://510kreport.com/methodology