# QOF: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents

- Device class: 2; regulation: 21 CFR 866.3981; FDA's rule: 510(k) required
- FDA decisions: 38
- 510(k) review time 2021–2025: median 178 days (middle half 87–238)
- Recalls: 5 (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
- 2023: 7
- 2024: 9
- 2025: 13
- 2026: 8

## Most-cited predicates
- DEN200031: BioFire Respiratory Panel 2.1 (RP2.1) (2021), cited by 13
- K233100: QIAstat-Dx® Respiratory Panel Plus (2024), cited by 3
- K241240: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (2024), cited by 3
- K220963: Simplexa COVID-19 & Flu A/B Direct (2023), cited by 2
- K213954: BIOFIRE SPOTFIRE Respiratory (R) Panel (2023), cited by 2
- K231481: Xpert Xpress CoV-2/Flu/RSV plus (2023), cited by 2
- K222736: Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay (2023), cited by 2
- K242071: Xpert Xpress CoV-2/Flu/RSV plus (2025), cited by 2
- K230719: BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini (2023), cited by 2
- K223591: cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (2023), cited by 1

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