FDA 510(k)

TRUE METRIX Self Monitoring Blood Glucose System

K-Number: K262116 · 2026-07-23

Decision Date2026-07-23

Product CodeNBW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TRUE METRIX Self Monitoring Blood Glucose System is the device name listed in this FDA 510(k) record. The listed applicant is Trividia Health, Inc.. It received FDA 510(k) clearance on 2026-07-23 under 510(k) number K262116. The device is classified under product code NBW. It was reviewed by the CH advisory panel. Product code NBW falls under the category of OB/GYN, which includes obstetric and gynecological diagnostic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUE METRIX Self Monitoring Blood Glucose System?

TRUE METRIX Self Monitoring Blood Glucose System is a medical device that received FDA 510(k) clearance on 2026-07-23. The listed applicant is Trividia Health, Inc.. The 510(k) number is K262116.

When did TRUE METRIX Self Monitoring Blood Glucose System receive FDA 510(k) clearance?

TRUE METRIX Self Monitoring Blood Glucose System received FDA 510(k) clearance on 2026-07-23, under 510(k) number K262116.

Who is the listed applicant for TRUE METRIX Self Monitoring Blood Glucose System?

The FDA 510(k) record lists Trividia Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUE METRIX Self Monitoring Blood Glucose System?

The FDA product code for TRUE METRIX Self Monitoring Blood Glucose System is NBW. This falls under the OB/GYN category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05947916Real Time Continuous Glucose Monitoring System in T2DM With PregnacyRECRUITING NCT06310356Continuous Glucose Monitoring for Women With Gestational DiabetesRECRUITING NCT06572306Pharmacist-led Continuous Glucose MonitoringRECRUITING NCT06628453CGM for Management of Type 2 Diabetes in PregnancyRECRUITING NCT06704672Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes MellitusRECRUITING NCT07095972Continuous Glucose Monitoring in Metabolic SurgeryNOT_YET_RECRUITING

Other records listing Trividia Health, Inc. as applicant

K221072TRUEdraw Lancing Device, Mini Lancing Device K143548TRUE METRIX GO Self Monitoring Blood Glucose System

Related Devices (Code: NBW)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.