FDA product code QWB: Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
QWB is the FDA product code for over-the-counter molecular test to detect sars-cov-2 from clinical specimens. It is a Class II device, regulated under 21 CFR 866.3984 and reviewed by the Microbiology panel. FDA has cleared 2 510(k) submissions under QWB, 2 in the last five years, from 2 different applicants. The average 510(k) review took 198 days (median 198); 305 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for QWB devices, 1 initiated in the last five years.
Definition
An over-the-counter molecular test to detect SARS-CoV-2 is an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without health care provider (HCP) intervention in home settings or similar environments.
Classification
| Field | Value |
|---|---|
| Device name | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens |
| Device class | Class II |
| Regulation | 21 CFR 866.3984 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QWB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 90 |
| 2026 | 1 | 305 |
Compare with all 510(k) review times · Search every QWB clearance
Top QWB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aptitude Medical Systems, Inc. | 1 | 2026-08-07 |
| Cue Health, Inc. | 1 | 2023-11-28 |
Most recent QWB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253453 | Aptitude Medical Systems, Inc. | Metrix COVID Test; Metrix COVID Test Pro | 2026-08-07 | 305 |
| K232643 | Cue Health, Inc. | Cue COVID-19 Molecular Test | 2023-11-28 | 90 |
Recalls for QWB devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-05-24.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code QWB?
QWB is the FDA product code for over-the-counter molecular test to detect sars-cov-2 from clinical specimens. It is a Class II device, regulated under 21 CFR 866.3984 and reviewed by the Microbiology panel.
What device class is QWB?
Class II, regulation 21 CFR 866.3984. Typical premarket route: 510(k).
How long does a 510(k) take for product code QWB?
Across 2 cleared submissions the average was 198 days from receipt to decision (median 198).
Which companies have the most QWB clearances?
Aptitude Medical Systems, Inc. (1); Cue Health, Inc. (1).
Have QWB devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2024-05-24.
Next steps
- Run an FDA pathway report with predicate devices for product code QWB
- Run a recall and safety report across every QWB manufacturer
- Watch product code QWB 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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