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Target Cannabinoids-R Test

by V-Tech, Inc. 510(k)

Active United States

510(k) K910893

Overview

The Target Cannabinoids-R Test is an enzyme immunoassay designed for the qualitative detection of cannabinoids in biological specimens. It functions as an analytical tool to identify the presence of cannabinoid compounds, aiding in clinical toxicology assessments.

This device is intended for in vitro use and is supplied as a single-use kit. It is classified as a Class II medical device under FDA regulations (862.3870) and has received FDA 510(k) clearance (K910893) for substantial equivalence. The test requires appropriate laboratory handling and storage as per manufacturer instructions, with no specific MRI safety considerations noted.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK910893 Date3 Apr 1991ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Target(Tm) Cannabinoids-R Test
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

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Questions

  • What is the primary purpose of the Target Cannabinoids-R Test in a clinical setting?

    The Target Cannabinoids-R Test is designed as an enzyme immunoassay for the qualitative detection of cannabinoids in biological specimens. It serves as a tool in clinical toxicology to help identify the presence of cannabinoid compounds, aiding in assessing potential exposure or intoxication in patients.

  • Is this test intended for single-use or can it be reused?

    The Target Cannabinoids-R Test is explicitly supplied as a single-use kit. This means each kit is intended for one-time use only, ensuring accuracy and preventing cross-contamination between samples.

  • How should the Target Cannabinoids-R Test be stored, and are there any special handling requirements?

    The test requires appropriate laboratory handling and storage as per the manufacturer’s instructions. While specific storage conditions (e.g., temperature, humidity) are not detailed in the provided data, it is critical to follow V-Tech, Inc.’s guidelines to maintain the test’s integrity and performance.

  • What regulatory pathway was followed for FDA clearance of this device?

    The Target Cannabinoids-R Test received FDA 510(k) clearance under the traditional pathway, demonstrating substantial equivalence to a predicate device. The clearance number is K910893, and it was classified as a Class II medical device under FDA regulation 862.3870, with the advisory committee designation for Clinical Toxicology.

  • Does this test require any special considerations, such as MRI safety, during use?

    No special MRI safety considerations are noted for the Target Cannabinoids-R Test. Since it is an in vitro diagnostic device used in laboratory settings, it does not interact with MRI environments or equipment.