QWB · Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
Microbiology · 21 CFR 866.3984 · Class 2
Overview
| Product Code | QWB |
|---|---|
| Device Name | Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens |
| Regulation | 21 CFR 866.3984 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253453 | Metrix COVID Test; Metrix COVID Test Pro | Aptitude Medical Systems, Inc. | Aug 7, 2026 | SESE |
| K232643 | Cue COVID-19 Molecular Test | Cue Health, Inc. | Nov 28, 2023 | SESE |
| DEN220028 | Cue COVID-19 Molecular Test | Cue Health, Inc. | Jun 6, 2023 | DENG |
Top Applicants
- Cue Health, Inc. — 2 clearances
- Aptitude Medical Systems, Inc. — 1 clearance
