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Ultegra System Rapid Platelet Function Assay (RPFA)

by Accumetrics, Inc.

510(k) K011337

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 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK011337 Date16 Oct 2001ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Ultegra System Rapid Platelet Function Assay (RPFA) is an automated system for platelet aggregation testing. It is classified as a Class II medical device under regulation number 864.5700 and has the product code JOZ.

The device is intended for use in point of care or laboratory settings to aid in the detection of platelet dysfunction due to aspirin ingestion in citrated whole blood. It received FDA 510(k) clearance (K011337) on October 16, 2001, and is substantially equivalent to a predicate device.

Other devices from Accumetrics, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Ultegra System Rapid Platelet Function Assay used for?

    The Ultegra System Rapid Platelet Function Assay (RPFA) is intended for use in point of care or laboratory settings to aid in the detection of platelet dysfunction due to aspirin ingestion in citrated whole blood by performing automated platelet aggregation testing.

  • How is the Ultegra System Rapid Platelet Function Assay supplied and is it reusable?

    The device data does not specify supply format or reusability; as an automated system for platelet aggregation testing, it likely includes reusable instrumentation with single-use test components, but exact details are not provided in the authorization records.

  • What regulatory pathway was used for the Ultegra System Rapid Platelet Function Assay?

    The Ultegra System Rapid Platelet Function Assay (RPFA) received FDA 510(k) clearance (K011337) on October 16, 2001, and was determined to be substantially equivalent to a predicate device under the traditional review pathway.