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    K Number
    K021944
    Device Name
    COZART EIA COTININE URINE KIT
    Manufacturer
    COZART BIOSCIENCE LTD.
    Date Cleared
    2003-05-14

    (335 days)

    Product Code
    MKU
    Regulation Number
    862.3220
    Type
    Traditional
    Panel
    Toxicology
    Reference & Predicate Devices
    K972481
    Why did this record match?
    Device Name :

    COZART EIA COTININE URINE KIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and analytical laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cut-off concentration of 500ng/ml. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine.

    This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.

    Device Description

    The Cozart EIA Cotinine Urine Kit test is a competitive ELISA for the detection of Cotinine in human urine. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 50, 500 and 5000ng/ml Cotinine in human urine).

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the Cozart EIA Cotinine Urine Kit, based on the provided text:

    Acceptance Criteria and Device Performance

    ParameterAcceptance Criteria (Implied by Predicate/Performance Claims)Reported Device Performance (Cozart EIA Cotinine Urine Kit)
    Intended UseQualitative test for Cotinine in human urine with a 500ng/ml cutoff. Recommendation for GC/MS confirmation.Qualitative test for Cotinine in human urine with a 500ng/ml cutoff. Recommendation for GC/MS confirmation.
    Method ComparisonHigh agreement with GC/MS for positive and negative samples.98% agreement for positive results (56/57), 100% agreement for negative results (38/38) with GC/MS (based on 95 samples).
    PrecisionCV (%) for the assay should be acceptable for qualitative ELISA (e.g.,
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