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510(k) Data Aggregation

    K Number
    K012943
    Device Name
    THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
    Manufacturer
    QUANTECH LTD.
    Date Cleared
    2002-01-18

    (140 days)

    Product Code
    NAL
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    NAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FasTraQ Automated Analyzer in coniunction with the PrePaQ Total hCG Cartridge is intended for use as an aid in the early detection of pregnancy where rapid, quantitative results in the emergency department or where other rapid diagnostics are required. The assay is to be used with patient whole blood samples. The Quantech PrePaQ Total hCG Test Cartridge is intended for use with the FasTraQ Automated Analyzer to provide rapid, quantitative measurement of human chorionic gonadotropin (hCG) in whole blood for the determination of pregnancy. The Analyzer and hCG Cartridge combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. The FasTraQ System is designed for use by non-laboratory medical professionals in emergency departments, STAT or central laboratories.
    Device Description
    The PrePaQ Cartridge in coniunction with the FasTraQ Automated Analyer is use to quantitate hCG in whole blood using surface plasmon resonance (SPR). The Quantech PrePaQ Total ß-hCG assay is based on the principle of two site, or sandwich immunoassay in combination with SPR surface mass measurement. Each PrePaQ cartridge contains a solid phase ß-hCG monoclonal antibody immobilized onto a gold surface. An anti-alpha hCG polyclonal antibody conjugated to alkaline phosphatase is attached to the antigen to form the sandwich. An enhancing solution is used to further increase the mass on the surface.
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    K Number
    K990258
    Device Name
    QUANTECH TOTAL B-HCG ASSAY
    Manufacturer
    QUANTECH LTD.
    Date Cleared
    1999-12-21

    (328 days)

    Product Code
    NAL
    Regulation Number
    862.1155
    Why did this record match?
    Product Code :

    NAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quantech Total β-hCG Assay is intended to be used, as aid in the early detection of pregnancy. The Quantech Total β-hCG Assay is intended to be used for the quantitative determination of human chorionic gonadotropin in EDTA-stabilized plasma, for the early detection of pregnancy.
    Device Description
    The Quantech Total ß-hCG assay is based on the principle of two site, or sandwich immunoassay in combination with surface plasmon resonance (SPR) surface mass measurement. Each test module contains a solid phase anti-ß-hCG monoclonal antibody immobilized onto a gold surface. An anti-hCG polyclonal antibody, used to enhance the specific detection by SPR is introduced sequentially.
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