Skip to content

The Triage II

by Biosite Incorporated

510(k) K924476

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK924476 Date22 Jan 1993ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1130-2012 FDA Not yet classified initiated 4 Jan 2012 on shared 510(k) K924476

    Alere San Diego received a rise in customer complaints regarding false positive Barbiturates (BAR) results on the Triage Drugs of Abuse Panel Plus TCA.

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  • Withdrawn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
DKZ
Device Class
Class II
Regulation
21 CFR Part 862.3100
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 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 II is an Enzyme Immunoassay for Amphetamine, classified under device class 2 and product code DKZ. It is a substantially equivalent device cleared through the traditional 510(k) pathway, with decision date January 22, 1993, and K number K924476. The device falls under the medical specialty of Clinical Toxicology and was reviewed by the Clinical Toxicology advisory committee.

Manufactured by Biosite Incorporated located at 11030 Roselle St., San Diego, CA 92121, the Triage II is registered under multiple FEI and registration numbers as listed in the specifications. It is regulated under regulation number 862.3100 and holds FDA 510(k) authorization. No information regarding sterility, single-use or reusable status, MRI safety, sizes, storage, or clinical indications is provided in the data.

Other devices from Biosite Incorporated

See all devices from Biosite Incorporated →

Questions

AI-generated answers, 22 Sep 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 Triage II used for?

    The Triage II is an enzyme immunoassay designed to detect amphetamine in clinical specimens, intended for use in clinical toxicology settings to support drug screening processes based on its cleared indication.

  • How is the Triage II supplied and is it sterile or single-use?

    The device data does not specify whether the Triage II is supplied sterile, single-use, or reusable; no information on sterility, use status, or packaging format is provided in the authorization records.

  • What sizes or models are available for the Triage II?

    The provided data does not include any details about sizes, models, or configurations of the Triage II; only the device name, manufacturer, and regulatory identifiers are specified.

  • How should the Triage II be stored?

    Storage conditions for the Triage II are not described in the device data; no information regarding temperature, humidity, or shelf-life requirements is available in the authorization records.

  • What regulatory pathway was used for the Triage II clearance?

    The Triage II received FDA 510(k) clearance through the traditional pathway as a substantially equivalent device, with decision date January 22, 1993, and K number K924476, based on its classification under product code DKZ and device class 2.