TRUE METRIX Self Monitoring Blood Glucose System

FDA 510(k) K262116 · Trividia Health, Inc.

Substantially Equivalent

510(k) numberK262116

Submission

Device name
TRUE METRIX Self Monitoring Blood Glucose System
Applicant
Trividia Health, Inc.
Fort Lauderdale, FL, US
Received
June 23, 2026
Decision date
July 23, 2026
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBW – System, Test, Blood Glucose, Over The Counter
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1345
Specialty
Clinical Chemistry

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Questions and answers

When was TRUE METRIX Self Monitoring Blood Glucose System cleared by the FDA?

TRUE METRIX Self Monitoring Blood Glucose System (K262116) received a 510(k) decision of Substantially Equivalent on July 23, 2026, 30 days after the submission was received.

What is the product code of K262116?

The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.