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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?
    Product Code :

    KZD

    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
    K974074
    Device Name
    INFUSION DYNAMICS POWER INFUSER
    Manufacturer
    INFUSION DYNAMICS, INC.
    Date Cleared
    1998-02-17

    (111 days)

    Product Code
    KZD
    Regulation Number
    880.5420
    Why did this record match?
    Product Code :

    KZD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ID Power Infuser™ is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock. The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments. The ID Power Infuser™ is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.
    Device Description
    Not Found
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    K Number
    K973843
    Device Name
    MSI PRESSURE INFUSOR
    Manufacturer
    SMITH ASSOC.
    Date Cleared
    1997-10-29

    (21 days)

    Product Code
    KZD
    Regulation Number
    880.5420
    Why did this record match?
    Product Code :

    KZD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medical Solutions, Inc.'s Reusable Pressure Infusor is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.
    Device Description
    a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.
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