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QuickPac II One Step Methamphetamine Test

by Drial Consultants, Inc. 510(k)

Active United States

510(k) K970724

Overview

The QuickPac II One Step Methamphetamine Test is an enzyme immunoassay designed for the qualitative detection of methamphetamine in urine samples. As classified under the nomenclature for enzyme immunoassays, this device provides a rapid, preliminary screening result for amphetamine-type substances, aiding in clinical toxicology assessments.

This single-use, non-sterile device is intended for use in clinical or forensic settings to screen urine specimens. It is regulated under FDA 510(k) clearance (K970724) and falls under the device class 2 category, adhering to regulatory standards for diagnostic tests. No MRI safety or reusable specifications are indicated in the data.

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

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970724 Date13 May 1997ClearedStatusActive

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 clinical setting is the QuickPac II One Step Methamphetamine Test designed for, and how does it function?

    The QuickPac II One Step Methamphetamine Test is designed for use in clinical or forensic settings to provide a rapid, preliminary screening of urine samples for methamphetamine. It uses an enzyme immunoassay (EIA) method, which is a biochemical technique to detect the presence of amphetamine-type substances. This test helps toxicology assessments by offering a quick, qualitative result to aid in further diagnostic or forensic evaluation.

  • Is the QuickPac II One Step Methamphetamine Test reusable, and what does that mean for its sterility?

    The QuickPac II One Step Methamphetamine Test is single-use only, meaning each device is intended for one-time use on a single urine sample. Since it is non-sterile, it should not be used in procedures requiring sterile conditions, such as invasive medical testing. Sterility is not applicable here, as the device is designed for non-invasive urine screening.

  • How is the QuickPac II One Step Methamphetamine Test supplied, and what should I consider when storing it?

    The QuickPac II One Step Methamphetamine Test is supplied as a single-use, non-sterile device in individual packaging. Storage requirements are not explicitly detailed in the data, but generally, such immunoassay tests should be stored in a cool, dry place away from direct sunlight and extreme temperatures. Always follow the manufacturer’s instructions for optimal performance.

  • What regulatory pathway was followed for FDA clearance of the QuickPac II One Step Methamphetamine Test?

    The QuickPac II One Step Methamphetamine Test received FDA 510(k) clearance under the classification of Enzyme Immunoassay, Amphetamine (product code: DKZ). The submission was reviewed by the Texas (TX) Advisory Committee and determined to be substantially equivalent to a predicate device, adhering to FDA’s regulatory standards for diagnostic tests in clinical toxicology. The clearance number is K970724, and the device falls under Class II classification.