510(k) K253453
K253453 is an FDA 510(k) premarket notification submitted by Aptitude Medical Systems, Inc. for the device "Metrix COVID Test; Metrix COVID Test Pro". The FDA issued a decision of Substantially Equivalent on August 7, 2026. The device falls under product code QWB (Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens), a Class II device regulated under 21 CFR 866.3984.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2026
- Date Received
- October 6, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
- Device Class
- Class II
- Regulation Number
- 866.3984
- Review Panel
- MI
- Submission Type
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.