Metrix COVID Test; Metrix COVID Test Pro— 510(k) K253453
Substantially EquivalentAptitude Medical Systems, Inc.
FDA 510(k) clearance K253453 for Metrix COVID Test; Metrix COVID Test Pro, Substantially Equivalent on 2026-08-07. Applicant: Aptitude Medical Systems, Inc.. Device class: 2.
Summary
Aptitude Medical Systems' submission lists the Metrix COVID Test and the Metrix COVID Test Pro. They're filed under product code QWB, over-the-counter molecular tests to detect SARS-CoV-2 from clinical specimens.
Class II, 21 CFR 866.3984. Microbiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Aptitude filed from Goleta, California. The decision came 305 calendar days after FDA received it (October 6, 2025 to August 7, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Aptitude Medical Systems, Inc.
- Product code
- Product code QWB
- Device class
- Class 2
- Regulation
- 21 CFR 866.3984
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Goleta, CA, US
Recent devices under product code QWB
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