BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    System, Test, Tumor Marker, For Detection Of Bladder Cancer

    PMA: P940035 · Supplement: S003 · Decision Apr 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    System, Test, Tumor Marker, For Detection Of Bladder Cancer
    Trade Name
    NMP22 BLADDERCHEK TEST KIT
    PMA Number
    P940035
    Supplement Number
    S003
    Device Class
    FDA Class 3
    Product Code
    NAH
    Generic Name
    System, test, tumor marker, for detection of bladder cancer
    Medical Specialty
    Unknown
    Advisory Committee
    Immunology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 25, 2003
    Date Received
    September 16, 2002
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR NEW TEST FORMAT TO BE MANUFACTURED AT MATRITECH, INC., NEWTON, MASSACHUSETTS AND AT A NEW FACILITY, UNOTECH DIAGNOSTICS, INC., SAN LEANDRO, CALIFORNIA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NMP22 BLADDERCHEK KIT AND IS INDICATED FOR THE FOLLOWING: THE MATRITECH NMP22 BLADDERCHEK TEST IS AN IN VITRO IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF NMP22 NUCLEAR MATRIX PROTEIN IN URINE OF PERSONS WITH RISK FACTORS OR SYMPTOMS OF BLADDER CANCER OR WITH A HISTORY OF BLADDER CANCER. THIS TEST IS INDICATED FOR PROFESSIONAL USE AND PRESCRIPTION HOME USE AS AN AID IN DIAGNOSING AND MONITORING BLADDER CANCER PATIENTS, IN CONJUNCTION WITH STANDARD DIAGNOSTIC PROCEDURES.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NAH System, Test, Tumor Marker, For Detection Of Bladder Cancer