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Accumetrics, Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow Prutest

by Accumetrics, Inc.

510(k) K141427

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 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK141427 Date24 Jul 2015ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0500-2026 FDA Class III initiated 21 Oct 2025

    Due to an device without a premarket clearance being incorrectly package and distributed.

    • Terminated Z-1121-2022 FDA Class II initiated 30 Mar 2022

    Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition.

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  • Withdrawn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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