# QUU: Simple In Vitro Diagnostic Device For The Detection Of Secreted Proteins From Bacillus Spp. In Human Clinical Samples

- Device class: 2; regulation: 21 CFR 866.3046; FDA's rule: 510(k) required
- FDA decisions: 2
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- 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)
- 2023: 2

## Most-cited predicates
- DEN220044: Active Anthrax DetectTM Plus Rapid Test (2023), cited by 1

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