# QBX: Direct Blood Bacterial Nucleic Acid Detection System

- Device class: 2; regulation: 21 CFR 866.3960; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 133 days (middle half 133–133)
- 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)
- 2018: 1
- 2024: 1

## Most-cited predicates
- K172708: T2Bacteria Panel (2018), cited by 1

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