TRUE METRIX Self Monitoring Blood Glucose System— 510(k) K262116
Substantially EquivalentTrividia Health, Inc.
FDA 510(k) clearance K262116 for TRUE METRIX Self Monitoring Blood Glucose System, Substantially Equivalent on 2026-07-23. Applicant: Trividia Health, Inc.. Device class: 2.
Summary
Trividia Health's TRUE METRIX Self Monitoring Blood Glucose System is filed under NBW, over-the-counter blood glucose test systems. The record doesn't list the system's components.
Class II, 21 CFR 862.1345. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Special 510(k).
Trividia Health filed from Fort Lauderdale, Florida. The decision came 30 calendar days after FDA received it (June 23 to July 23, 2026).
Clearance details
- Applicant
- Trividia Health, Inc.
- Product code
- Product code NBW
- Device class
- Class 2
- Regulation
- 21 CFR 862.1345
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fort Lauderdale, FL, US
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More clearances from Trividia Health, Inc.
view allAdverse events under product code NBW
product code NBW- Death
- 18
- Injury
- 4,740
- Malfunction
- 42,679
- Other
- 6
- Total
- 47,443
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.