# QYT: Over-The-Counter Covid-19 Antigen Test

- Device class: 2; regulation: 21 CFR 866.3984; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 179 days (middle half 117–220)
- 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: 1
- 2024: 5
- 2025: 5
- 2026: 3

## Most-cited predicates
- K230828: Flowflex COVID-19 Antigen Home Test (2023), cited by 7
- K233373: Flowflex® Plus COVID-19 Home Test (2024), cited by 1
- K240728: CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test (2024), cited by 1
- K241313: OHC COVID-19 Antigen Self Test (2025), cited by 1
- K231795: QuickVue COVID-19 Test (2024), cited by 1

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