# QVF: Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

- Device class: 2; regulation: 21 CFR 866.3982; FDA's rule: 510(k) required
- FDA decisions: 10
- 510(k) review time 2021–2025: median 181 days (middle half 157–264)
- 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
- 2024: 3
- 2025: 3
- 2026: 2

## Most-cited predicates
- DEN220039: Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set (2023), cited by 5
- K231187: Nano-Check™ COVID-19 Antigen Test (2024), cited by 4

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