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Biosite Triage Panel For Drugs Of Abuse (50NG/ML)

by Biosite Incorporated

510(k) K931598

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK931598 Date12 May 1993ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
LDJ
Device Class
Class II
Regulation
21 CFR Part 862.3870
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Biosite Triage Panel For Drugs Of Abuse is an enzyme immunoassay device used for the qualitative determination of parent compounds and/or major metabolites of up to nine distinct drug classes in urine samples. This device is classified as a Class II medical device and is intended for clinical toxicology applications. The panel provides a screening method for detecting various drug substances in urine specimens.

The device is supplied as a single-use panel and requires appropriate storage conditions as specified by the manufacturer. It received FDA 510(k) clearance with number K931598 on May 12, 1993, and is manufactured by Biosite Incorporated in San Diego, California. The device is not indicated for MRI safety and should be used according to the manufacturer's instructions for proper handling and interpretation of results.

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