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Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)

by Accumetrics, Inc.

510(k) K013596

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK013596 Date16 May 2002ClearedStatusActive

Recalls

2 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.

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  • Withdrawn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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