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510(k) Data Aggregation

    K Number
    K033743
    Device Name
    COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT
    Manufacturer
    COZART BIOSCIENCE LTD.
    Date Cleared
    2004-06-03

    (188 days)

    Product Code
    KZD, DKZ
    Regulation Number
    880.5420
    Why did this record match?
    Applicant Name (Manufacturer) :

    COZART BIOSCIENCE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is intended for use in clinical and forensic laboratories when used in conjunction with the Cozart® RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for amphetamines in human oral fluid at a cutoff concentration of 15ng/ml. This is equal to 45ng/ml in neat oral fluid as the collection system involves a 1:3 dilution of the sample. 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 (GCMS) is the preferred confirmatory method.
    Device Description
    The Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a laboratory based test for the detection of amphetamines in human oral fluid using a cutoff equivalent to 45ng/mL. The device detailed above was compared to Gas Chromatography/Mass Spectrometry (GC/MS). As can be seen from the Principle of the Test section in the pack insert, the Cozart® EIA Amphetamines Oral Fluid Microplate Kit is a competitive ELISA for the detection of amphetamines in human oral fluid. The Cozart® EIA Amphetamines Oral Fluid Microplate kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 2, 15 and 50ng/ml amphetamine in oral fluid matrix).
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    COZART BIOSCIENCE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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).
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    K Number
    K030234
    Device Name
    COZART EIA COCAINE ORAL FLIUD KIT
    Manufacturer
    COZART BIOSCIENCE LTD.
    Date Cleared
    2003-04-28

    (95 days)

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

    COZART BIOSCIENCE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cozart EIA Cocaine Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for cocaine and metabolites in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/ml. in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample. 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 Cocaine Oral Fluid Kit is a laboratory based test for the detection of cocaine and metabolites in human oral fluid using a cutoff equivalent to 30ng/mL. The Cozart EIA Cocaine Oral Fluid Kit is a competitive ELISA for the detection of cocaine and its metabolites in human oral fluid. 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, 5, 10 and 50ng/ml benzoylecgonine in oral fluid matrix).
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    K Number
    K024339
    Device Name
    COZART EIA OPIATES ORAL FLUID KIT
    Manufacturer
    COZART BIOSCIENCE LTD.
    Date Cleared
    2003-04-07

    (101 days)

    Product Code
    DIG
    Regulation Number
    862.3240
    Why did this record match?
    Applicant Name (Manufacturer) :

    COZART BIOSCIENCE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cozart EIA Opiates Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for Opiates in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/mL in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample. 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
    Not Found
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    K Number
    K020920
    Device Name
    COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE
    Manufacturer
    COZART BIOSCIENCE LTD.
    Date Cleared
    2002-11-05

    (229 days)

    Product Code
    DJG, DJR
    Regulation Number
    862.3650
    Why did this record match?
    Applicant Name (Manufacturer) :

    COZART BIOSCIENCE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cozart RapiScan Oral Fluid Drug Test System - Opiates and Methadone is intended for Point of Care testing in a number of settings such as prescription workplace, drug dependency clinics, and criminal justice. It provides qualitative screening results for opiates and methadone in human oral fluid at a cut-off concentration equivalent to 40ng/mL and 30ng/mL respectively in neat oral fluid. The cozart collection system involves a 1:3 dilution of the oral fluid sample, this dilution factor is corrected for in the Cozart RapiScan Drug Test and therefore the remainder of this document will refer to the cut-offs as 13ng/mL for opiates and 10ng/ml for methadone. This kit has to be used in conjunction with the Cozart RapiScan instrument. Please refer to the sampling and testing procedures in the instructions for use leaflet. 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. It is the responsibility of those organisations required to follow department of transportation (DOT) or the Substance Abuse and Mental Health Services Administration (SAMHSA) Workplace Drug Testing guidelines to determine that this product satisfies the criteria for workplace testing established under DOT and SAMHSA.
    Device Description
    The Cozart RapiScan opiates and methadone test system is composed of three parts - the oral fluid collection device, the opiates and methadone test cartridge and the Cozart RapiScan instrument. 1. Oral fluid Collection Device: composed of an oral fluid collector pad, a transport tube containing run buffer and a dispense filter tube. 2. Opiate and Methadone Test Cartridge: composed of a white reaction strip with immobilized drug sites for opiates and methadone contained in a blue plastic casing. The cartridge also has a pad containing gold labeled anti-morphine and gold labeled anti-methadone antibodies. In addition, the cartridge has a built in control line of sheep anti-mouse IgG antibody. 3. Cozart RapiScan Instrument: a battery-powered instrument whose function is to automate the analysis of the opiate/methadone test cartridge. It is a hand-held low voltage optical scanner.
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    K Number
    K011131
    Device Name
    METHADONE MICROPLATE EIA URINE APPLICATION
    Manufacturer
    COZART BIOSCIENCE LTD.
    Date Cleared
    2001-07-31

    (109 days)

    Product Code
    DJR
    Regulation Number
    862.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    COZART BIOSCIENCE LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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