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VerifyNow System 85021

by Accriva Diagnostics Holdings, Inc.

VerifyNow System 85021 is a Class II device made by Accriva Diagnostics Holdings, Inc., cleared under FDA 510(k) K992531 on 20 Dec 1999, registered in EUDAMED and listed in FDA GUDID since 6 Apr 2021 (UDI-DI 10711234500095), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K992531

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number10711234500095 UDI-DI Date6 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK992531 Date20 Dec 1999DecidedStatusActive
European UnionCE/IVDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K992531 decided 20 Dec 1999 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI 10711234500095 listed 6 Apr 2021 Listed

Recalls

3 recalls · FDA

    • Terminated Z-1172-2014 FDA Class II initiated 13 Feb 2014

    Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU.

    • Terminated Z-0482-2014 FDA Class II initiated 14 Nov 2013

    Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample. The correct instruction is to perform the test within 15 minutes of collecting the patient sample.

    • Terminated Z-0102-06 FDA Unclassified (pre-2012) initiated 13 Sep 2005

    In 2001, separate reports of mild shock, sparking and smoke from Accumetrics PN 29001 power supply.

Timeline

5 dated events

  1. Cleared FDA 510(k) K992531
  2. Recall initiated FDA recalls Z-0102-06
  3. Recall initiated FDA recalls Z-0482-2014
  4. Recall initiated FDA recalls Z-1172-2014
  5. Listed FDA GUDID 10711234500095

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
VerifyNow System
Generic name
Platelet aggregation analyser IVD
Model / Ref / Catalog
85021
Primary DI / UDI-DI
10711234500095
510(k) Number
FDA product code
JOZ
GMDN term
Platelet aggregation analyser IVD
Device class
Class II
Regulation number
864.5700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Platelet aggregation analyser IVD

Cleared under the same submission (K992531)

and 4 more cleared under K992531

Similar devices in this category

Other devices filed under Platelet aggregation analyser IVD.

Other devices from Accriva Diagnostics Holdings, Inc.

See all devices from Accriva Diagnostics Holdings, Inc. →

Properties

  • Convenience kit
  • Serial number
Other properties (13, all answered No)