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G5 I HBA1C Test, G5 II HBA1C Test

by Provalis Diagnostics, Ltd.

510(k) K041635

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK041635 Date16 Aug 2004ClearedStatusActive

Recalls

4 recalls · FDA

    • Terminated Z-0109-2011 FDA Unclassified (pre-2012) initiated 7 Sep 2010

    Test Cartridges may leak and have the potential to generate error messages and biased inaccurate results.

    • Terminated Z-0122-2011 FDA Unclassified (pre-2012) initiated 26 Jul 2010

    Inaccurate results with high bias-- Inaccurate results may be read by the machine, creating the risk for untreated hypoglycemia at elevated altitudes.

    • Terminated Z-2460-2008 FDA Unclassified (pre-2012) initiated 3 Aug 2006

    Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.

    • Terminated Z-0171-06 FDA Unclassified (pre-2012) initiated 20 May 2005

    Provalis Diagnostics discovered, following its internal stability testing program (mid-point batch testing), that occasional low values were being found across multiple lots of in2it HbA1C Test Cartridges.

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  • Withdrawn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
LCP
FDA applicant
Provalis Diagnostics , Ltd.
Device Class
Class II
Regulation
21 CFR Part 864.7470
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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