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Truetrack Smart System Blood Glucose Meter and True Track Smart System Blood Glucose Test Strips

by Home Diagnostics, Inc.

510(k) K030703

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030703 Date11 Jul 2003ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

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

    Product gives incorrect low blood glucose levels.

    • 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  • Withdrawn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 — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NBW
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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