← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K970724

# QUICKPAC II ONE STEP METHAMPHETAMINE TEST (K970724)

_Drial Consultants, Inc. · DKZ · May 13, 1997 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K970724

## Device Facts

- **Applicant:** Drial Consultants, Inc.
- **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md)
- **Decision Date:** May 13, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Indications for Use

The QuikPac II One Step Methamphetamine Test is intended for medical/forensic screening of urine.

## Device Story

Chromatographic absorbent device for qualitative urine drug screening; utilizes competitive immunoassay principle. Drug/metabolites in urine sample compete with immobilized drug conjugate on porous membrane for limited antibody sites. Labeled antibody-dye conjugate binds to free drug; complex competes with immobilized antigen in positive reaction zone. Absence of magenta band indicates drug presence above 500 ng/ml; presence of magenta band in control zone confirms reagent/device function. Used in clinical/forensic settings; operated by laboratory personnel. Provides visual qualitative result; assists in identifying potential methamphetamine exposure; positive results require confirmation via GC/MS.

## Clinical Evidence

Clinical trial of 305 urine samples. Compared against Syva EMIT® II with GC/MS confirmation for discrepant results. Reported relative sensitivity 100%, relative specificity 97.7%, and overall accuracy 98.68%. In-house testing showed 100% accuracy against Syva EMIT® II.

## Technological Characteristics

Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; competitive immunoassay format. Qualitative visual readout. No electronic components or software.

## Regulatory Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

## Special Controls

*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

## Reference Devices

- Syva EMIT® II

## Submission Summary (Full Text)

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K970724

510k Submission for

MAY 13 1997

QuikPac II One Step Methamphetamine Test

Syntron Bioresearch, Inc.

Revision C 4/11/97 Printed on 4/22/97

Page 58 of 58 Pages

# Summary of Safety and Effectiveness

The sponsor, Syntron Bioresearch, Inc. (2774 Loker Ave. West, Carlsbad, California, 92008), has developed, manufactured and tested under GMP/GLP guidelines a device for the qualitative testing of urine for the presence of Methamphetamine and its metabolites in a screening format.

The trade name of the device is QuikPac II One Step Methamphetamine Test having a designated common name of Methamphetamine Test System and a classification as a class II device per 21 CFR ¶ 862.3610. This device is intended for medical/forensic screening of urine.

Syntron's QuikPac II One Step Methamphetamine Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites. As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level of 500 ng/ml. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly.

In-house testing of Syntron's QuikPac II One Step Methamphetamine Test yielded a relative sensitivity and specificity of 1.00 and an accuracy of 100% when tested against Syva EMIT® II on samples documented to be positive by GC/MS. A clinical trial consisting of 305 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 97.7% with an accuracy of 98.68%.

All positive samples by either screening method were confirmed by GC/MS. The results on the 6 discrepant samples clearly demonstrated the specificity of the QuikPac II One Step Methamphetamine Test. Four of the 6 samples were negative for methamphetamine, but positive for Amphetamine by GC/MS. The other two were negative for methamphetamine but positive for pseudoephedrine and phenyl propanolamine (PPA) respectively.

Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, President, Drial Consultants, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K970724](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K970724)

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