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Verifynow-P2Y12 Assay

by Accumetrics, Inc.

510(k) K051231

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK051231 Date5 Aug 2005ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1853-2012 FDA Class II initiated 6 Feb 2012
    • Terminated Z-1854-2012 FDA Class II initiated 6 Feb 2012

    The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic

    • Terminated Z-0228-2007 FDA Unclassified (pre-2012) initiated 5 Sep 2006

    The VerifyNow P2Y12 assay can report an erroneous result instead of an error message when a sample with low hematocrit is run.

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  • Withdrawn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
JOZ
Device Class
Class II
Regulation
21 CFR Part 864.5700
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

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