# DBM: Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

- Device class: 2; regulation: 21 CFR 866.5090; FDA's rule: 510(k) required
- FDA decisions: 27
- Recalls: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1995: 1
- 1996: 1
- 1997: 1
- 1998: 1
- 2003: 2
- 2005: 1
- 2010: 1
- 2015: 1
- 2017: 2
- 2018: 1

## Most-cited predicates
- K052262: Quanta Lite M2 EP (MIT3) Elisa (2005), cited by 4
- K141375: Elia M2; Immunoassay, Positive Control 100, Positive Control 250 (2015), cited by 1

Source page: https://510kreport.com/product-code/DBM
Data by year (CSV): https://510kreport.com/product-code/DBM.csv