Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K163570
    Device Name
    Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)
    Manufacturer
    Carolina Liquid Chemistries Corporation
    Date Cleared
    2017-08-15

    (239 days)

    Product Code
    DIO
    Regulation Number
    862.3250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Carolina Liquid Chemistries Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is for the qualitative determination of benzoylecgonine (cocaine metabolite) in human urine at a cutoff value of 300 ng/mL. The assay is designed for professional use with a clinical chemistry analyzer. For in vitro diagnostic use only. This assay provides a rapid screening procedure for determining the presence of benzoylecgonine in urine. The assay provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
    Device Description
    Carolina Liquid Chemistries Cocaine Metabolite Test System (COCM) is a ready-to-use, liquid reagent, homogenous enzyme immunoassay. The assay uses a specific antibody that can detect benzoylecgonine (cocaine metabolite) in human urine with minimal cross-reactivity to various, common prescription drugs and abused drugs. The assay is based on competition between benzoylecgonine and glucose-6-phosphate dehydrogenase (G6PDH) enzyme, and free drug from the urine sample for a fixed amount of the specific antibody. In the absence of free drug from the urine sample the specific antibody binds to the drug labeled with G6PDH enzyme causing a decrease in enzyme activity. The G6PDH enzyme activity is determined spectrophotometrically and 340nm by measuring its ability to convert nicotinamide adenine dinucleotide (NAD) to NADH.
    Ask a Question

    Page 1 of 1