# K052262: Quanta Lite M2 EP (MIT3) Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Oct 27, 2005 after 69 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K141375: Elia M2; Immunoassay, Positive Control 100, Positive Control 250 (2015), 1 descendant of its own
- K181556: EliA M2 Immunoassay (2018), 0 descendants of its own
- K163525: QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls (2017), 0 descendants of its own
- K113439: Euroimmun Euroline Profile Autoimmune Liver Disease 8AG (Igg) (2013), 0 descendants of its own
- K092736: Euroimmun Anti-M2-3E Elisa (Igg) (2010), 0 descendants of its own

## Indications for use
The QUANTA LiteTM M2 EP (MIT3) ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of mitochondrial antibodies in human serum. The presence of mitochondrial antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of primary biliary cirrhosis.

Source page: https://510kreport.com/device/K052262
Methodology: https://510kreport.com/methodology