← Product Code [DIO](/productcode/DIO) · K954496 # FRONTLINE COCAINE (K954496) _Boehringer Mannheim Corp. · DIO · Mar 6, 1996 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K954496 ## Device Facts - **Applicant:** Boehringer Mannheim Corp. - **Product Code:** [DIO](/productcode/DIO.md) - **Decision Date:** Mar 6, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3250 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use For use in the qualitative analysis of cocaine metabolite (benzoylecgonine) in human urine at a cutoff concentration of 300 ng/mL. ## Device Story FRONTLINE® COCAINE is a non-instrumented, immunochromatographic test for qualitative analysis of benzoylecgonine in human urine. Device utilizes Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Input: human urine sample. Mechanism: capillary action draws urine through a compartment containing colloidal gold-labeled monoclonal antibodies; conjugate binds to benzoylecgonine; excess conjugate retained by solid phase; bound complex migrates to detection pad. Output: visual red-colored complex on detection pad. User compares color intensity against provided scale on vial to classify sample as positive (≥300 ng/mL) or negative. Used in clinical or testing settings; no instrumentation or calibration required. ## Clinical Evidence Bench testing and clinical comparison performed. 513 metabolized urine samples evaluated across two sites. Comparison against FPIA and confirmation method showed 58 positive and 450 negative results; 5 false positives reported. ## Technological Characteristics Immunochromatographic assay (GLORIA technology). Components: monoclonal antibodies reactive to benzoylecgonine derivative, colloidal gold conjugate, benzoylecgonine polyhapten, bulking agents, stabilizers, preservatives. Non-instrumented, visual read format. No calibration required. ## Regulatory Identification A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose. ## Special Controls *Classification.* Class II (special controls). A cocaine and cocaine metabolite 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). ## Predicate Devices - TDx® Cocaine Metabolite ## 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} k954496 # 510(k) SUMMARY - FRONTLINE® COCAINE Submitter Name: Boehringer Mannheim GmbH Submitter Address: Sandhofer Str. 116 D-68298 Mannheim, Germany Contact Person: Richard Naples, Director Regulatory and Government Affairs Phone Number: (317) 576-3858 Fax Number: (317) 845-2324 Date Prepared: February 29, 1996 Device Trade Name: FRONTLINE® COCAINE Device Common Name: Immunochromatographic test for cocaine and cocaine metabolite Classification Name: Cocaine and cocaine metabolite test system (per 21 CFR §862.3250) Predicate Device: TDx® Cocaine Metabolite Device Description: FRONTLINE® COCAINE is a homogeneous immunochromatographic assay for use in the qualitative analysis of cocaine metabolite (benzoylecgonine) in human urine. The assay is based on Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Each test strip contains monoclonal antibodies reactive to a benzoylecgonine derivative labeled with colloidal gold (conjugate) and benzoylecgonine polyhapten, bulking agents, stabilizers and preservatives (solid phase). When immersed in urine, the test strip absorbs the volume of fluid necessary for the chromatographic reaction to occur. By capillary action, the urine passes through a compartment containing soluble conjugate which specifically binds to the benzoylecgonine analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with bound-benzoylecgonine analyte passes to the detection pad where a red-colored conjugate-analyte complex is viewed. The color developed on the detection pad is compared visually with a scale provided on the test strip vial. The intensity of the color developed correlates with the concentration of the analyte in the sample and the user may classify the analyte sample as: negative or positive (≥300 ng/mL). Intended Use: For use in the qualitative analysis of cocaine metabolite (benzoylecgonine) in human urine at a cutoff concentration of 300 ng/mL. 2.3 {1} Device Technological Characteristics and Comparison to Predicate Devices: FRONTLINE® is based on Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Each test strip contains monoclonal antibodies reactive to a benzoylecgonine derivative labeled with colloidal gold (conjugate) and benzoylecgonine polyhepten, bulking agents, stabilizers and preservatives (solid phase). When immersed in urine, the test strip absorbs the volume of fluid necessary for the chromatographic reaction to occur. By capillary action, the urine passes through a compartment containing soluble conjugate which specifically binds to the benzoylecgonine analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with bound benzoylecgonine analyte passes to the detection pad where a red-colored conjugate-analyte complex is viewed. The color developed on the detection pad is compared visually with a scale provided on the test strip vial. FRONTLINE® COCAINE is a non-instrumented assay and requires no user calibration. TDx® Cocaine Metabolite is a fluorescence polarization immunoassay (FPIA) in which the change in fluorescence polarization due to antibody binding correlates with the concentration of analyte in the sample. Results are measured with a suitable instrument and compared to those generated by defined calibrators. Performance Data: Comparison to FPIA: A total of 513 metabolized urine samples were evaluated at two sites. 58 samples were FRONTLINE® positive and 450 were FRONTLINE® negative when compared to FPIA and the confirmation method. Five samples were classified as false positive. Conclusion: FRONTLINE® COCAINE is substantially equivalent to other commercially available cocaine metabolite test systems. 2 24 --- **Source:** [https://fda-staging.innolitics.com/device/K954496](https://fda-staging.innolitics.com/device/K954496) **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