# K181556: EliA M2 Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Phadia AB
- Decided: Jul 13, 2018 after 30 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: 2 generations back to K052262 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141375: Elia M2; Immunoassay, Positive Control 100, Positive Control 250, Phadia US, Inc. (2015) Summary page 6.

## Indications for use
EliA M2 is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to M2 in human serum and plasma (Li-heparin, EDTA) to aid in the clinical diagnosis of primary biliary cirrhosis in conjunction with other laboratory and clinical findings. EliA M2 uses the EliA IgG method on the instrument Phadia 2500/5000.

Source page: https://510kreport.com/device/K181556
Methodology: https://510kreport.com/methodology