# MWA: System, Nucleic Acid Amplification, Mycobacterium Tuberculosis Complex

- Device class: 2; regulation: 21 CFR 866.3372; FDA's rule: 510(k) required
- FDA decisions: 2
- 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)
- 1996: 4
- 1998: 2
- 2000: 1
- 2002: 1
- 2004: 4
- 2005: 2
- 2007: 2
- 2008: 3
- 2010: 1
- 2012: 1

## Most-cited predicates

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