# NIJ: System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species

- Device class: 2; regulation: 21 CFR 866.1640; FDA's rule: 510(k) required
- FDA decisions: 6
- 510(k) review time 2021–2025: median 20 days (middle half 20–20)
- Recalls: 0 (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)
- 2002: 1
- 2006: 1
- 2009: 1
- 2011: 1
- 2013: 1
- 2024: 1

## Most-cited predicates
- K092953: Xpert VanA Assay (2009), cited by 2
- K061686: Idi-Vanr Assay (2006), cited by 1
- K102416: BD Geneohm Vanr Assay (2011), cited by 1

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