# PEU: System, Nucleic Acid-Based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen

- Device class: 2; regulation: 21 CFR 866.3373; FDA's rule: 510(k) required
- FDA decisions: 2
- Recalls: 1 (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)
- 2013: 1
- 2015: 1

## Most-cited predicates
- DEN130032: Xpert MTB/Rif Assay (2013), cited by 1

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