# QWB: Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens

- Device class: 2; regulation: 21 CFR 866.3984; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- 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)
- 2023: 2
- 2026: 1

## Most-cited predicates
- DEN220028: Cue COVID-19 Molecular Test (2023), cited by 3

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