Clearance Summary
Metrix COVID Test; Metrix COVID Test Pro received FDA 510(k) clearance under submission number K253453, sponsored by Aptitude Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2026-08-07.
- Submission: K253453
- Applicant / Sponsor: Aptitude Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3984
- Decision date: 2026-08-07
Classification & Regulation
This clearance is catalogued under FDA product code QWB and 21 CFR 866.3984, within the Microbiology review panel as a Class II device.