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Quest Diagnostics HairCheck-DT (THC)

by Quest Diagnostics, Inc.

510(k) K040257

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 NumberK040257 Date14 Jun 2004ClearedStatusActive

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  • Withdrawn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, 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 Quest Diagnostics HairCheck-DT (THC) is an enzyme immunoassay device for the qualitative detection of cannabinoids, specifically THC-COOH, in head hair. It employs an enzyme-linked immunosorbent assay (ELISA) methodology with a cutoff concentration of 1.0 pg/mg of hair for screening purposes.

The device is supplied as a test kit comprising four component packages: microplates, conjugate reagents, common reagents, and calibrator/controls. It is intended for use in clinical laboratory settings and has received FDA 510(k) clearance under product code LDJ and regulation number 862.3870, with a device classification as Class II.

Other devices from Quest Diagnostics, Inc.

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 Quest Diagnostics HairCheck-DT (THC) used for?

    The Quest Diagnostics HairCheck-DT (THC) is used for the qualitative detection of cannabinoids, specifically THC-COOH, in head hair samples. It is designed as a screening tool in clinical laboratory settings to identify the presence of THC metabolites above a cutoff concentration of 1.0 pg/mg of hair using an enzyme-linked immunosorbent assay (ELISA) methodology.

  • How is the Quest Diagnostics HairCheck-DT (THC) supplied and what does the test kit include?

    The device is supplied as a test kit comprising four component packages: microplates, conjugate reagents, common reagents, and calibrator/controls. These components are intended for use together in clinical laboratory settings to perform the enzyme immunoassay for THC-COOH detection in hair specimens.

  • Is the Quest Diagnostics HairCheck-DT (THC) intended for single-use or reuse, and what are the storage requirements?

    The device is intended for use in clinical laboratory settings and is supplied as a test kit with reagents and controls; however, the provided data does not specify whether individual components are single-use or reusable, nor does it detail storage conditions such as temperature or stability requirements. Users should refer to the manufacturer’s labeling for specific handling, storage, and reuse instructions.