Who is the manufacturer of QUICKPAC II ONE STEP METHAMPHETAMINE TEST?

Drial Consultants, Inc. filed the 510(k) submission for QUICKPAC II ONE STEP METHAMPHETAMINE TEST (K970724).

What is the FDA product code for QUICKPAC II ONE STEP METHAMPHETAMINE TEST?

DKZ. It is classified under 21 CFR 862.3100 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for QUICKPAC II ONE STEP METHAMPHETAMINE TEST?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like QUICKPAC II ONE STEP METHAMPHETAMINE TEST?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

QUICKPAC II ONE STEP METHAMPHETAMINE TEST

K970724 · Drial Consultants, Inc. · DKZ · May 13, 1997 · Clinical Toxicology

Device Facts

Record ID	K970724
Device Name	QUICKPAC II ONE STEP METHAMPHETAMINE TEST
Applicant	Drial Consultants, Inc.
Product Code	DKZ · Clinical Toxicology
Decision Date	May 13, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3100
Device Class	Class 2

Intended 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.

Indications for Use

Indicated for the qualitative screening of human urine for the presence of Methamphetamine and its metabolites at a cutoff concentration of 500 ng/ml. Intended for medical and forensic use.

Regulatory Classification

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

Related Devices

K970265 — ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST · Drial Consultants, Inc. · Apr 8, 1997
K970395 — QUIKSTRIP ONE STEP METHAMPHETAMINE · Drial Consultants, Inc. · Jun 26, 1997
K971109 — QUIKPAC II ONE STEP AMPHETAMINE TEST · Drial Consultants, Inc. · May 14, 1997
K973269 — QUIKSTRIP ONE STEP BENZODIAZEPINE TEST · Drial Consultants, Inc. · Feb 25, 1998
K971218 — QUIKSTRIP ONE STEP AMPHETAMINE TEST · Drial Consultants, Inc. · May 30, 1997

Submission Summary (Full Text)

{0} 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.