Metrix COVID Test; Metrix COVID Test Pro
Device Facts
| Record ID | K253453 |
|---|---|
| Device Name | Metrix COVID Test; Metrix COVID Test Pro |
| Applicant | Aptitude Medical Systems, Inc. |
| Product Code | QWB · Microbiology |
| Decision Date | Aug 7, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.3984 |
| Device Class | Class 2 |
Regulatory Classification
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.
