← Product Code [LDJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ) · K951853 # ONE STEP URINE DRUG OF ABUSE CANNABINOID TEST (THC) (K951853) _Tcpi, Inc. · LDJ · Aug 20, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ/K951853 ## Device Facts - **Applicant:** Tcpi, Inc. - **Product Code:** [LDJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ.md) - **Decision Date:** Aug 20, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3870 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use This device is intended for medical/forensic screening of urine. ## Device Story Chromatographic absorbent device for qualitative urine drug screening; detects Cannabinoids/metabolites. Principle: competitive immunoassay; drug/metabolites in sample compete with immobilized drug conjugate for limited antibody sites. Labeled antibody-dye conjugate binds free drug; complex migrates up membrane. Positive result: no magenta band at reaction zone (drug >50 ng/ml). Control zone: unbound dye conjugate produces magenta band confirming device function. Used in clinical/forensic settings; operated by laboratory personnel. Output: visual colorimetric band interpretation. Assists healthcare providers/forensic analysts in identifying potential drug presence for further confirmatory testing. ## Clinical Evidence Bench testing: 249 individual urine samples compared against Sigma SIA, Syva Emit, and GC/MS; sensitivity 1.00, specificity 1.00, accuracy 100%. Clinical trial (NIDA certified lab): sensitivity 1.00, specificity 0.9935, accuracy 99.67% vs GC/MS gold standard. ## Technological Characteristics Chromatographic absorbent device; porous membrane support; antibody-dye conjugate; immobilized antigen conjugate. Qualitative visual readout. No electronic components or software. ## Regulatory Identification A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use. ## Special Controls *Classification.* Class II (special controls). A cannabinoid 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™ THC - Syva Emit - GC/MS ## 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} K951853 510k Submission for 20 00 One Step™ Urine drug of abuse Cannabinoid Test (THC) - K951853 Technical Chemicals & Products, Inc. Revision A- 4/17/95, B-10/3195, C-3/20/96, printed on 3/20/96 ## 9. Summary 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 Cannabinoids and their metabolites in a screening format. This summary was originally written in May of 1995 and has been updated as of March, 1996 The Trade name of the device is One Step™ Urine Drug of Abuse Cannabinoid Test (THC) having a designated common name of Cannabinoid Test System and a classification as a class II device per 21 CFR 862.3870. This device is intended for medical/forensic screening of urine. TCPI's One Step™ Urine Drug of Abuse Cannabinoids 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 50 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. The sponsor subjected the final product to both in house testing of 249 individual urine samples using both the Sigma SIA™ THC, Syva Emit and GC/MS against the new product. The calculated sensitivity and specificity both equal 1.00 with the accuracy of 100%. Subsequently the device was subjected to a broader clinical trial in a NIDA certified laboratory where the calculated sensitivity equaled 1.00, the specificity equaled 0.9935 and the calculated accuracy equaled 99.67% when compared to the gold standard of GC/MS. Statistical comparisons of all possible combinations of reference methods to the experimental new device failed to identify any significant difference. Additional information on this submission may be obtained by contacting Dr. Cleve W. Laird, Exec Vice President, Technical Chemicals & Products Inc. at 954-979-0400 or by fax at 954-979-0009. --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ/K951853](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LDJ/K951853) **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