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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Nontreponemal, All
510(k) Number K250249
Device Name Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System
Applicant
Gold Standard Diagnostics, LLC
2795 2nd St. Suite 300
Davis,  CA  95618
Applicant Contact Douglas McGarvey
Correspondent
Gold Standard Diagnostics, LLC
2795 2nd St. Suite 300
Davis,  CA  95618
Correspondent Contact Gerrit Mueller
Regulation Number866.3820
Classification Product Code
GMQ  
Date Received01/27/2025
Decision Date 10/10/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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