← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K971109 # QUIKPAC II ONE STEP AMPHETAMINE TEST (K971109) _Drial Consultants, Inc. · DKZ · May 14, 1997 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K971109 ## Device Facts - **Applicant:** Drial Consultants, Inc. - **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md) - **Decision Date:** May 14, 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 Amphetamine Test is intended for professional medical/forensic screening of urine. ## Device Story Chromatographic absorbent device for qualitative urine drug screening; lateral flow immunoassay principle. Sample flows through membrane; drug/metabolites compete with immobilized drug conjugate for limited antibody sites. Labeled-antibody-dye conjugate binds free drug; complex competes with immobilized antigen in positive reaction zone. Absence of magenta band indicates drug presence >500 ng/ml; presence of magenta band in control zone confirms reagent/device function. Used in professional medical/forensic settings; operated by trained personnel. Visual interpretation of color bands by clinician; results provide preliminary screening data requiring GC/MS confirmation for positive results. ## Clinical Evidence Clinical trial of 308 urine samples compared QuikPac II to Syva EMIT® II. Results: 100% relative sensitivity, 100% relative specificity, 100% accuracy. All positive screening results confirmed by GC/MS. Discrepant analysis identified cross-reactivity with Ephedrine and Phenyl PropanolAmine (PPA). ## Technological Characteristics Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; lateral flow immunoassay. Qualitative visual readout. No external energy source. Standalone test kit. ## 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 510k Submission for QuikPac II One Step Amphetamine Test Syntron Bioresearch, Inc. Revision B 2/17/97 Printed on 3/24/97 K971109 MAY 14 1997 Page 54 of 54 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 Amphetamine and its metabolites in a screening format. The trade name of the device is QuikPac II One Step Amphetamine Test having a designated common name of Amphetamine Test System and a classification as a class II device per 21 CFR ¶ 862.3100. This device is intended for professional medical/forensic screening of urine. Syntron's QuikPac II One Step Amphetamine 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 Amphetamine 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 308 samples was run and the combined data yielded a relative sensitivity of 100%, a relative specificity of 100%, and an accuracy of 100% when compared to Emit® II. All positive samples by either screening method were confirmed by GC/MS. The results on the 13 discrepant samples clearly demonstrate the same errors by both. Thirteen (13) of the samples were positive for Amphetamine by either Emit® II or QuikPac II, but negative for Amphetamine by GC/MS. Of these 13 false positives twelve (12) were positive for Ephedrine by GC/MS and one (1) was positive for Phenyl PropanolAmine (PPA) by GC/MS. Additional information pertaining to 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. --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K971109](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K971109) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com