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Triage Tox Drug Screen, Model 94400

by Biosite Incorporated

510(k) K060791

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

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 NumberK060791 Date22 Jun 2006ClearedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-1214-2014 FDA Class II initiated 5 Feb 2014

    Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results.

    • Terminated Z-2460-2012 FDA Class II initiated 12 Jul 2012 on shared 510(k) K060791

    Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots: AMP, BAR, and PCP, the threshold ranges may not be consistently set correctly in all meters.

    • Terminated Z-2039-2012 FDA Class II initiated 14 May 2012

    A recall was initiated because Alere San Diego has confirmed that the Triage TOX Drug Screen may have significantly decreased precision and accuracy than claimed. An increased frequency of false positive and/or false negative results has been observed for Triage TOX Drug Screen.

    • Terminated Z-1446-2012 FDA Unclassified (pre-2012) initiated 12 Mar 2010

    The recall was initiated because Biosite Inc. received an increase in customer calls regarding unexpected positive THC results when using the Triage TOX Drug Screen.

    • Terminated Z-0029-2013 FDA Class II initiated 28 May 2009

    Biosite is recalling the Triage TOX Drug Screen kits where the box containing test devices because it was mislabeled.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DJR
Device Class
Class II
Regulation
21 CFR Part 862.3620
Advisory Committee
Clinical Toxicology
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 Triage Tox Drug Screen, Model 94400 is an enzyme immunoassay test system for methadone, classified under product code DJR and regulation number 862.3620. It is designed for use in clinical toxicology settings to detect methadone in specimens.

The device was cleared by the FDA through the 510(k) process (K060791) on June 22, 2006, and is classified as a Class II device with special controls. It is manufactured by Biosite Incorporated in San Diego, California.

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