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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Molecular Test To Detect Sars-Cov-2 From Clinical Specimens
510(k) Number K253453
Device Name Metrix COVID Test; Metrix COVID Test Pro
Applicant
Aptitude Medical Systems, Inc.
125 Cremona D
Suite 100
Goleta,  CA  93117
Applicant Contact Tyler Chozinski
Correspondent
Aptitude Medical Systems, Inc.
125 Cremona D
Suite 100
Goleta,  CA  93117
Correspondent Contact Tyler Chozinski
Classification Product Code
QWB  
Date Received10/06/2025
Decision Date 08/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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