FDA product code QOF: Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents
QOF is the FDA product code for multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents. It is a Class II device, regulated under 21 CFR 866.3981 and reviewed by the Microbiology panel. FDA has cleared 31 510(k) submissions under QOF, 31 in the last five years, from 17 different applicants. The average 510(k) review took 179 days (median 179); 190 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 8 recalls for QOF devices, 8 initiated in the last five years.
Definition
A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Classification
| Field | Value |
|---|---|
| Device name | Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents |
| Device class | Class II |
| Regulation | 21 CFR 866.3981 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QOF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 7 | 212 |
| 2024 | 9 | 144 |
| 2025 | 13 | 174 |
| 2026 | 2 | 252 |
Compare with all 510(k) review times · Search every QOF clearance
Top QOF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biofire Diagnostics, LLC | 4 | 2025-08-14 |
| Roche Molecular Systems, Inc. | 4 | 2025-07-31 |
| Diasorin Molecular, LLC | 3 | 2025-12-23 |
| QIAGEN GmbH | 3 | 2025-08-27 |
| Cepheid® | 3 | 2025-05-01 |
12 more applicants have QOF clearances. See the full list in Caduvo.
Most recent QOF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252269 | Baebies, Inc. | FINDER Flu A&B/SARS-CoV-2 Test | 2026-03-30 | 252 |
| K251742 | Lex Diagnostics Limited | VELO Respiratory Test | 2026-02-13 | 252 |
| K251978 | Diasorin Molecular, LLC | LIAISON NES FLU A/B, RSV & COVID-19 | 2025-12-23 | 179 |
| K252387 | Diasorin Molecular, LLC | Simplexa COVID-19/ Flu A/B & RSV Direct (MOL4450); Simplexa COVID-19/ Flu A/B & RSV Positive Control Pack (MOL4460) | 2025-10-30 | 91 |
| K250080 | QIAGEN GmbH | QIAstat-Dx Respiratory Panel Plus; QIAstat-Dx Respiratory Panel Mini | 2025-08-27 | 226 |
Recalls for QOF devices
8 product recalls in 8 recall events; 8 initiated in the last five years and 8 still open. Most recent: 2026-04-01.
| Year | Recalls |
|---|---|
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code QOF?
QOF is the FDA product code for multi-target respiratory specimen nucleic acid test including sars-cov-2 and other microbial agents. It is a Class II device, regulated under 21 CFR 866.3981 and reviewed by the Microbiology panel.
What device class is QOF?
Class II, regulation 21 CFR 866.3981. Typical premarket route: 510(k).
How long does a 510(k) take for product code QOF?
Across 31 cleared submissions the average was 179 days from receipt to decision (median 179).
Which companies have the most QOF clearances?
Biofire Diagnostics, LLC (4); Roche Molecular Systems, Inc. (4); Diasorin Molecular, LLC (3); QIAGEN GmbH (3); Cepheid® (3).
Have QOF devices been recalled?
Yes: 8 product recalls across 8 recall events; the most recent began 2026-04-01.
Next steps
- Run an FDA pathway report with predicate devices for product code QOF
- Run a recall and safety report across every QOF manufacturer
- Watch product code QOF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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