FDA product code QVF: Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
QVF is the FDA product code for simple point-of-care device to directly detect sars-cov-2 viral 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 9 510(k) submissions under QVF, 9 in the last five years, from 9 different applicants. The average 510(k) review took 200 days (median 181); 221 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A simple point-of-care device to detect SARS-CoV-2 viral 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 Directly Detect Sars-Cov-2 Viral 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 QVF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 26 |
| 2024 | 3 | 285 |
| 2025 | 3 | 165 |
| 2026 | 2 | 214 |
Compare with all 510(k) review times · Search every QVF clearance
Top QVF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 1 | 2026-09-04 |
| CorDx, Inc. | 1 | 2026-06-01 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 2025-10-22 |
| Becton, Dickinson and Company | 1 | 2025-06-16 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 2025-06-13 |
4 more applicants have QVF clearances. See the full list in Caduvo.
Most recent QVF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254264 | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | 2026-09-04 | 248 |
| K253882 | CorDx, Inc. | CorDx Tyfast COVID-19 Ag Rapid Test Rx | 2026-06-01 | 179 |
| K251289 | Guangzhou Wondfo Biotech Co., Ltd. | WELLlife COVID-19 Antigen Test Rx | 2025-10-22 | 180 |
| K243872 | Becton, Dickinson and Company | BD Veritor System for SARS-CoV-2 | 2025-06-16 | 181 |
| K250273 | Abbott Diagnostics Scarborough, Inc. | BinaxNOW COVID-19 Ag Card | 2025-06-13 | 134 |
Recalls for QVF devices
openFDA lists no recalls for product code QVF.
Frequently asked questions
What is FDA product code QVF?
QVF is the FDA product code for simple point-of-care device to directly detect sars-cov-2 viral 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 QVF?
Class II, regulation 21 CFR 866.3982. Typical premarket route: 510(k).
How long does a 510(k) take for product code QVF?
Across 9 cleared submissions the average was 200 days from receipt to decision (median 181).
Which companies have the most QVF clearances?
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) (1); CorDx, Inc. (1); Guangzhou Wondfo Biotech Co., Ltd. (1); Becton, Dickinson and Company (1); Abbott Diagnostics Scarborough, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QVF
- Run a recall and safety report across every QVF manufacturer
- Watch product code QVF 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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