# QNJ: Mass Spectrometry, Microorganism Identification, Blood Culture

- Device class: 2; regulation: 21 CFR 866.3378; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 182 days (middle half 182–182)
- 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)
- 2020: 1
- 2024: 1

## Most-cited predicates
- K193419: MBT Sepsityper (2020), cited by 2

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