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Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)

by Omega Laboratories, Inc.

510(k) K101973

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 NumberK101973 Date16 Aug 2011ClearedStatusActive

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  • Withdrawn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
LAF
Device Class
Class II
Regulation
21 CFR Part 862.3610
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Omega Laboratories Hair Drug Screening Assay for Methamphetamine and 4-Methylenedioxymethamphetamine (MDMA) is a laboratory developed test intended for the determination of the presence of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. It is classified as a gas chromatography-based device under device class II, with product code LAF and regulation number 862.3610.

The assay received FDA 510(k) clearance (K101973) on August 16, 2011, following a traditional review process and was found substantially equivalent. It is used in clinical toxicology settings and is supplied as a laboratory test system for hair specimen analysis, with no indication of sterility, single-use, or reusable status provided in the data.

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Questions

AI-generated answers, 25 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 Omega Laboratories Hair Drug Screening Assay used for?

    This assay is intended for the determination of the presence of methamphetamine and 3,4-methylenedioxymethamphetamine (MDMA) in human hair from the crown of the head. It is used in clinical toxicology settings to support drug testing and monitoring.

  • How is the Omega Laboratories Hair Drug Screening Assay supplied and what type of specimen does it analyze?

    The assay is supplied as a laboratory test system designed for the analysis of human hair specimens. It requires hair samples collected from the crown of the head and is processed using gas chromatography-based methodology in a laboratory environment.

  • Is the Omega Laboratories Hair Drug Screening Assay sterile, single-use, or reusable?

    The provided data does not indicate whether the assay is sterile, single-use, or reusable. As a laboratory developed test system, it is intended for use in a controlled lab setting where reagents and procedures are managed according to standard laboratory practices.