BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P940035 · Supplement: S008 · Decision Mar 21, 2012
    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
    ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT
    PMA Number
    P940035
    Supplement Number
    S008
    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
    March 21, 2012
    Date Received
    November 22, 2010
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE INTENT TO MANUFACTURE THE NMP22 BLADDERCHEK TEST AND NMP22 BLADDERCHEK CONTROL KIT UNDER ALERE SCARBOROUGH, INC. BRAND NAME. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAME: ALERE NMP22 BLADDERCHEK TEST, WITH THE FOLLOWING INTENDED USE: THE ALERE NMP22 BLADDERCHEK TEST IS AN IN VITRO IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF THE NUCLEAR MITOTIC APPARATUS PROTEIN (NUMA), WHICH IS AN ABUNDANT COMPONENT OF THE NUCLEAR MATRIX PROTEINS, 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.ALERE NMP22 BLADDERCHEK CONTROL KIT, WITH THE FOLLOWING INTENDED USE: ALERE NMP22 BLADDERCHEK CONTROL KIT IS DESIGNED TO PROVIDE THE USERS OF THE ALERE NMP22 BLADDERCHEK TEST WITH ADDITIONAL, OPTIONAL, QUALITY CONTROLS FOR OPERATING THE TEST.

    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