FDA product code QQX: Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
QQX is the FDA product code for respiratory specimen nucleic acid sars-cov-2 test. It is a Class II device, regulated under 21 CFR 866.3981 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under QQX, 10 in the last five years, from 7 different applicants. The average 510(k) review took 212 days (median 203); 213 days on average over the last three years.
Definition
A device to detect and identify nucleic acid targets in respiratory specimens from SARS-CoV-2 that cause COVID-19 is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 nucleic acid targets in human clinical respiratory specimens from patients suspected of COVID-19 based on signs and symptoms of respiratory infections by their healthcare providers. The device is intended to aid in the diagnosis of COVID-19 in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.
Classification
| Field | Value |
|---|---|
| Device name | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test |
| 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 QQX
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 1 | 203 |
| 2022 | 3 | 273 |
| 2023 | 2 | 130 |
| 2024 | 2 | 225 |
| 2025 | 3 | 201 |
Compare with all 510(k) review times · Search every QQX clearance
Top QQX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Molecular Systems, Inc. | 3 | 2025-02-11 |
| Cepheid® | 2 | 2025-01-15 |
| Biofire Defense, LLC | 2 | 2022-07-25 |
| Hologic, Inc. | 1 | 2025-02-13 |
| Abbott Molecular | 1 | 2024-12-06 |
2 more applicants have QQX clearances. See the full list in Caduvo.
Most recent QQX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243396 | Hologic, Inc. | Aptima SARS-CoV-2 Assay | 2025-02-13 | 105 |
| K240867 | Roche Molecular Systems, Inc. | cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems | 2025-02-11 | 319 |
| K242109 | Cepheid® | Xpert® Xpress CoV-2 plus (XPRS-COV2-10) | 2025-01-15 | 180 |
| K241580 | Abbott Molecular | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) | 2024-12-06 | 186 |
| K233453 | Life Technologies Corporation | Applied Biosystems TaqPath COVID-19 Diagnostic PCR Kit | 2024-07-10 | 264 |
Recalls for QQX devices
openFDA lists no recalls for product code QQX.
Frequently asked questions
What is FDA product code QQX?
QQX is the FDA product code for respiratory specimen nucleic acid sars-cov-2 test. It is a Class II device, regulated under 21 CFR 866.3981 and reviewed by the Microbiology panel.
What device class is QQX?
Class II, regulation 21 CFR 866.3981. Typical premarket route: 510(k).
How long does a 510(k) take for product code QQX?
Across 11 cleared submissions the average was 212 days from receipt to decision (median 203).
Which companies have the most QQX clearances?
Roche Molecular Systems, Inc. (3); Cepheid® (2); Biofire Defense, LLC (2); Hologic, Inc. (1); Abbott Molecular (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QQX
- Run a recall and safety report across every QQX manufacturer
- Watch product code QQX 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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