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Target Amphetamine/Methamphetamine-V (Visual Meth)

by V-Tech, Inc. 510(k)

Active United States

510(k) K910738

Overview

The Target Amphetamine/Methamphetamine-V (Visual Meth) is an enzyme immunoassay device designed to measure amphetamine and methamphetamine levels in plasma and urine. This test system aids in the diagnosis and treatment of amphetamine or methamphetamine use and overdose, as well as monitoring drug levels to ensure appropriate therapy.

The device is manufactured by V-Tech, Inc. and is classified as Class II under FDA regulation 862.3100. It is intended for clinical toxicology applications and received FDA 510(k) clearance on March 19, 1991, with the K number K910738. The device is supplied with multiple registration numbers and is designed for professional laboratory use.

AI-generated from registry data, 26 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 NumberK910738 Date19 Mar 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)

510(k) Number
FDA Product Code
DKZ
Device Class
Class II
Regulation
21 CFR Part 862.3100
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Target Amphetamine/Methamphetamine-V (Visual Meth) device used for?

    The Target Amphetamine/Methamphetamine-V (Visual Meth) is an enzyme immunoassay device designed to measure amphetamine and methamphetamine levels in plasma and urine. It aids in the diagnosis and treatment of amphetamine or methamphetamine use and overdose, as well as monitoring drug levels to ensure appropriate therapy.

  • How is the Target Amphetamine/Methamphetamine-V device supplied?

    The device is supplied with multiple registration numbers and is designed for professional laboratory use. It is manufactured by V-Tech, Inc. and is classified as Class II under FDA regulation 862.3100.

  • Is the Target Amphetamine/Methamphetamine-V device sterile?

    The device description does not specify sterility information. As a laboratory test device, it is typically handled following standard laboratory protocols for handling biological samples and reagents.

  • Is the Target Amphetamine/Methamphetamine-V device single-use or reusable?

    The device description does not explicitly state whether it is single-use or reusable. As an enzyme immunoassay device, it is typically designed for single-use per test procedure to ensure accurate results and prevent cross-contamination.

  • What is the regulatory status of the Target Amphetamine/Methamphetamine-V device?

    The device received FDA 510(k) clearance on March 19, 1991, with the K number K910738. It is classified as Class II under FDA regulation 862.3100 and is intended for clinical toxicology applications.