# QQX: Respiratory Specimen Nucleic Acid Sars-Cov-2 Test

- Device class: 2; regulation: 21 CFR 866.3981; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 203 days (middle half 143–292)
- 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)
- 2021: 1
- 2022: 3
- 2023: 2
- 2024: 2
- 2025: 3

## Most-cited predicates
- K211079: BioFire COVID-19 Test 2 (2021), cited by 7
- K213804: cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (2022), cited by 2
- K231306: cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (2023), cited by 1
- K230440: Xpert® Xpress CoV-2 plus (2023), cited by 1
- K221460: BioFire COVID-19 Test 2 (2022), cited by 1

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