FDA product code QWR: Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
QWR is the FDA product code for simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings. It is a Class II device, regulated under 21 CFR 866.3982 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under QWR, 3 in the last five years, from 2 different applicants. The average 510(k) review took 308 days (median 353); 165 days on average over the last three years. FDA has posted 2 recalls for QWR devices, 2 initiated in the last five years.
Definition
A simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.
Classification
| Field | Value |
|---|---|
| Device name | Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings |
| Device class | Class II |
| Regulation | 21 CFR 866.3982 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QWR
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 2 | 379 |
| 2025 | 1 | 165 |
Compare with all 510(k) review times · Search every QWR clearance
Top QWR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Roche Molecular Systems, Inc. | 2 | 2025-04-11 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 2023-08-10 |
Most recent QWR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243346 | Roche Molecular Systems, Inc. | cobas liat SARS-CoV-2 v2 nucleic acid test | 2025-04-11 | 165 |
| K223783 | Roche Molecular Systems, Inc. | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | 2023-12-04 | 353 |
| K221925 | Abbott Diagnostics Scarborough, Inc. | ID NOW COVID-19 2.0 | 2023-08-10 | 405 |
Recalls for QWR devices
2 product recalls in 2 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-03-04.
| Year | Recalls |
|---|---|
| 2025 | 2 |
Frequently asked questions
What is FDA product code QWR?
QWR is the FDA product code for simple point-of-care device to detect sar-cov-2 nucleic acid targets from clinical specimens in near-patient settings. It is a Class II device, regulated under 21 CFR 866.3982 and reviewed by the Microbiology panel.
What device class is QWR?
Class II, regulation 21 CFR 866.3982. Typical premarket route: 510(k).
How long does a 510(k) take for product code QWR?
Across 3 cleared submissions the average was 308 days from receipt to decision (median 353).
Which companies have the most QWR clearances?
Roche Molecular Systems, Inc. (2); Abbott Diagnostics Scarborough, Inc. (1).
Have QWR devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2025-03-04.
Next steps
- Run an FDA pathway report with predicate devices for product code QWR
- Run a recall and safety report across every QWR manufacturer
- Watch product code QWR 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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