# QVP: Sars-Cov-2 Serology Test

- Device class: 2; regulation: 21 CFR 866.3983; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 53 days (middle half 34–71)
- 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: 2
- 2026: 1

## Most-cited predicates
- DEN210040: VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators (2023), cited by 2
- K250768: Elecsys Anti-SARS-CoV-2 (2025), cited by 1

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