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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K262116
Device Name TRUE METRIX Self Monitoring Blood Glucose System
Applicant
Trividia Health, Inc.
2400 NW 55th Ct.
Fort Lauderdale,  FL  33309
Applicant Contact Jacqueline Davis
Correspondent
Trividia Health, Inc.
2400 NW 55th Ct.
Fort Lauderdale,  FL  33309
Correspondent Contact Jacqueline Davis
Regulation Number862.1345
Classification Product Code
NBW  
Date Received06/23/2026
Decision Date 07/23/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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