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510(k) Data Aggregation

    K Number
    K021231
    Device Name
    NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT
    Manufacturer
    MATRITECH, INC.
    Date Cleared
    2002-07-30

    (103 days)

    Product Code
    MMW
    Regulation Number
    866.6010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MATRITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NMP22 BladderChek Test is indicated for professional and prescription home use as an aid in monitoring bladder cancer patients, in conjunction with standard diagnostic procedures.
    Device Description
    The NMP22 BladderChek Test for nuclear matrix protein NMP22 is an immunochromatographic assay utilizing monoclonal antibodies in a lateral flow strip encased in plastic. Two different antibodies are used, one as a capture and one as a reporter antibody. Unprocessed patient urine is added to the sample well of the cartridge and allowed to react with the colloidal gold conjugated reporter antibody. If the antigen is present in urine, it will interact with the reporter conjugate to form an immune complex. The reaction mixture flows through the membrane, which contains zones of immobilized antibodies. In the Test (T) zone, antigen-conjugate complexes are trapped by the capture antibody, forming a visible line if the concentration of antigen in urine is elevated. The procedural Control (C) zone contains an immobilized goat anti-mouse IgG-specific antibody that will capture the conjugated antibody independently of the presence or absence of the antigen, thereby always producing a visible line in the Control window. This procedural control assures the operator that each device is working properly.
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