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USDT Cannabinoid (THC) Assay Column Catalog No. 9000-500

by U.S. Drug Testing, Inc. 510(k)

Active United States

510(k) K940912

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK940912 Date2 Jun 1994ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is an Enzyme Immunoassay Column designed for the qualitative detection of cannabinoids, including delta-9-tetrahydrocannabinol (THC), in biological samples. It functions as part of a laboratory assay system to identify cannabinoid presence, aiding in the diagnosis of cannabinoid use or abuse, as well as monitoring levels during clinical investigations.

The USDT Cannabinoid (THC) Assay Column Catalog No. 9000-500 is supplied as a single-use component for laboratory testing and requires no sterilization beyond manufacturer packaging. It is classified as a Class II device under FDA regulations (862.3870) and was granted FDA 510(k) clearance (K940912) under the Traditional pathway, with a decision date of June 2, 1994. The device is intended for use in clinical toxicology settings and is regulated under the LDJ product code.

Other devices from U.S. Drug Testing, Inc.

Questions

AI-generated answers, 19 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 USDT Cannabinoid (THC) Assay Column primarily used for in a clinical setting?

    The USDT Cannabinoid (THC) Assay Column is designed for the qualitative detection of cannabinoids, including delta-9-tetrahydrocannabinol (THC), in biological samples. It is used as part of a laboratory assay system to help identify the presence of cannabinoids, which aids in diagnosing cannabinoid use or abuse, as well as monitoring levels during clinical investigations, particularly in clinical toxicology settings.

  • Is the USDT Cannabinoid (THC) Assay Column intended for single-use or can it be reused?

    The USDT Cannabinoid (THC) Assay Column is explicitly supplied as a single-use component for laboratory testing. It is not intended for reuse, and no additional sterilization beyond the manufacturer’s packaging is required.

  • What regulatory pathway was used for FDA clearance of this device, and when was it granted?

    The USDT Cannabinoid (THC) Assay Column received FDA 510(k) clearance under the Traditional pathway on June 2, 1994. The device is classified as a Class II medical device under FDA regulations (862.3870) and is regulated under the LDJ product code for clinical toxicology applications.

  • How is the USDT Cannabinoid (THC) Assay Column packaged and stored?

    The device is supplied in manufacturer packaging that provides the necessary sterility for single-use applications. While no additional sterilization is required, it should be stored according to the manufacturer’s instructions to maintain its integrity and performance, though specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data.