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St Aia-Pack Testosterone Assay

by Tosoh Medics, Inc.

510(k) K023091

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023091 Date17 Dec 2002ClearedStatusActive

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-2746-2026 FDA Class II initiated 12 Jun 2026

    The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could cause falsely elevated or falsely low total testosterone results. Such erroneous test results may lead to additional testing/diagnostic interventions and in limited cases, may lead to a delay in diagnosis and/or initiation of unnecessary or incorrect clinical treatment measures.

    • Terminated Z-0674-2019 FDA Class II initiated 30 Nov 2018
    • Terminated Z-2093-2018 FDA Class II initiated 5 Mar 2018

    Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.

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  • Withdrawn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
CDZ
Device Class
Class I
Regulation
21 CFR Part 862.1680
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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