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510(k) Data Aggregation

    K Number
    K014024
    Device Name
    MODIFICATION TO ALPHA DX SYSTEM
    Manufacturer
    FIRST MEDICAL, INC.
    Date Cleared
    2001-12-18

    (12 days)

    Product Code
    MMIGKFJHXKHO
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha DX Analyzer. The Alpha DX Cardiac Panel Test Kits are fluorescence Immunoassay Analyzer for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.
    Device Description
    Not Found
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    K Number
    K013118
    Device Name
    MODIFICATION TO ALPHA DX SYSTEM
    Manufacturer
    FIRST MEDICAL, INC.
    Date Cleared
    2001-10-15

    (27 days)

    Product Code
    JHXDDRKHOMMI
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer. The analyzer is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.
    Device Description
    The Alpha Dx Analyzer is a fluorescence Immunoassay Analyzer for use with the Alpha Dx Panel Test Kits.
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    K Number
    K010562
    Device Name
    ALPHA DX SYSTEM
    Manufacturer
    FIRST MEDICAL, INC.
    Date Cleared
    2001-03-13

    (15 days)

    Product Code
    MMIDDRGKFJHXKHO
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K974839
    Device Name
    ALPHA DX ANALYZER 01-0100, ALPHA DX MYO/CK/CK-MB/TNI CARDIAC PANEL TEST KIT 03-0001, ALPHA DX CK/CK-MB PANEL TEST KIT
    Manufacturer
    FIRST MEDICAL, INC.
    Date Cleared
    1998-02-04

    (42 days)

    Product Code
    MMICGXDDRJHXKHO
    Regulation Number
    862.1215
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIRST MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer to provide rapid, quantitative and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The Analyzer and Cardiac Panel Test Kit combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. With factory calibration, built-in bilevel quality controls and closed tube sampling, the system can be used in the central laboratory, STAT lab, emergency department, coronary care unit, chest pain center and other point of care locations.
    Device Description
    The Alpha Dx Cardiac Panel Test Kits, when used with the Alpha Dx Analyzer, are fluorescence immunoassays for the rapid measurement of myoglobin, CK, CK-MB and TnI in human whole blood or serum. The Alpha Dx Cardiac Panel Test Kits are two-site fluorescence immunoassays. Monoclonal and polyclonal antibodies are used in the Alpha Dx Cardiac Panel Test Kits.
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