510(k) K262116

TRUE METRIX Self Monitoring Blood Glucose System by Trividia Health, Inc. — Product Code NBW

K262116 is an FDA 510(k) premarket notification submitted by Trividia Health, Inc. for the device "TRUE METRIX Self Monitoring Blood Glucose System". The FDA issued a decision of Substantially Equivalent on July 23, 2026. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Trividia Health, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 2026
Date Received
June 23, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Blood Glucose, Over The Counter
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type