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TRUEtrack BLOOD GLUCOSE METER

by Trividia Health, Inc. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00021292001261 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-2881-2016 FDA Class II initiated 28 Jun 2016

    Product gives incorrect low blood glucose levels.

    • Terminated Z-0910-2014 FDA Class II initiated 2 Oct 2013

    Manufactured with an incorrect factory set unit of measure.

    • Terminated Z-1140-2013 FDA Class II initiated 25 Feb 2013

    Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TRUEtrack
Generic Name
Glucose monitoring system IVD, home-use
Model / Ref / Catalog
TRUEtrack BLOOD GLUCOSE METER, A4027-81
Primary DI / UDI-DI
00021292001261
510(k) Number
FDA Product Code
NBW, CGA, JJX
GMDN Term
Glucose monitoring system IVD, home-use
Device Class
Class II
Regulation Number
862.1345, 862.1660
GUDID distribution status
Not in Commercial Distribution

From the manufacturer

Manufacturer's product page: Blood Glucose Monitoring System

Related devices

Cleared under the same submission (K032657)

Show all (9)

Other devices from Trividia Health, Inc.

See all devices from Trividia Health, Inc. →

Properties

  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Serial Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Manufacturing Date: No