# QWR: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

- Device class: 2; regulation: 21 CFR 866.3982; FDA's rule: 510(k) required
- FDA decisions: 3
- 510(k) review time 2021–2025: median 353 days (middle half 259–379)
- 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
- 2025: 1

## Most-cited predicates
- K221925: ID Now Covid-19 2.0 (2023), cited by 2
- K223783: cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (2023), cited by 1

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