← Product Code [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ) · K970265 # ONE STEP URINE DRUG OF ABUSE METHAMPHETAMINE TEST (K970265) _Drial Consultants, Inc. · DKZ · Apr 8, 1997 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K970265 ## Device Facts - **Applicant:** Drial Consultants, Inc. - **Product Code:** [DKZ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ.md) - **Decision Date:** Apr 8, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3100 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use This device is intended for professional medical/forensic screening of urine for Methamphetamine. ## Device Story Chromatographic absorbent device for qualitative urine screening; detects Methamphetamine and metabolites. Principle: competitive immunoassay; drug in sample competes with immobilized drug conjugate on porous membrane for limited antibody sites. Sample flow carries labeled antibody-dye conjugate; binds free drug to form antibody-antigen complex. Positive result (drug >500 ng/ml): no magenta band in reaction zone. Negative result: magenta band appears. Control zone: unbound dye conjugate binds reagent to confirm device function. Used in professional medical/forensic settings by clinicians/technicians. Provides rapid screening results to assist in identifying potential drug use; requires confirmatory testing for definitive diagnosis. ## Clinical Evidence Clinical trial of 300 urine samples compared against GC/MS. Results: positive agreement 1.00; negative agreement 0.948; overall concordance 97.24%; accuracy 94.67%. Initial testing against Sigma SIA™ showed 1.00 sensitivity/specificity and 100% concordance. False positives noted with ephedrine and phenylpropanolamine. ## Technological Characteristics Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; competitive immunoassay principle. Qualitative visual readout (magenta color bands). No electronic components, software, or external energy source required. ## 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 - Sigma SIA™ ## 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 One Step™ URINE DRUG OF ABUSE METHAMPHETAMINE TEST Technical Chemicals & Products, Inc. Page 22 of 51 APR - 8 1997 Revision E 3/17/97 Printed on 3/21/97 ## 8. STATEMENT OF SAFETY AND EFFECTIVENESS The sponsor, Technical Chemicals and Products, Inc. (3340 S.W. 15th Street, Pompano Beach, Florida, 33069), 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. This summary was originally written in May of 1995 and has been updated as of January, 1997. The trade name of the device is One Step™ Urine Drug of Abuse 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 professional medical/forensic screening of urine for Methamphetamine. TCPI’s One Step™ Urine Drug of Abuse 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 up 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. Initial testing of the TCPI One Step Methamphetamine Test yielded a relative sensitivity and specificity of 1.00 and a concordance of 100% when tested against Sigma SIA™ on samples documented to be positive by GC/MS. A clinical trial consisting of 300 samples was run and the data yielded agreement within the positive samples of 1.00, and agreement within the negative samples of 0.907 when compared to GC/MS and an accuracy of 94.67%. When all the data was combined, the agreement within the positive samples remained 1.00, while the agreement within the negative samples rose to 0.948 with a concordance of 97.24%. Like all of the screening methods tested TCPI’s will report false positives when ephedrine and phenyl propanolamine are present. Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, Exec Vice President, Technical Chemicals & Products, Inc. at 805-522-6223(Ca) or by fax at 805-522-1526. Proprietary Information Confidential Do Not Copy Proprietary Information Confidential --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K970265](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKZ/K970265) **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. 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