BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P940035 · Supplement: S007 · Decision Jan 20, 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 URINE COLLECTION KIT
    PMA Number
    P940035
    Supplement Number
    S007
    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
    January 20, 2012
    Date Received
    July 27, 2011
    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 NMP22 TEST KIT AND NMP22 URINE COLLECTION KIT UNDER ALERE SCARBOROUGH, INCS BRAND NAME. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER: TRADE NAME ALERE NMP22 TEST WITH THE FOLLOWING INTENDED USE: ALERE NMP22 TEST IS AN ENZYME IMMUNOASSAY (EIA) FOR THE IN VITRO QUANTITATIVE DETERMINATION OF THE NUCLEAR MITOTIC APPARATUS PROTEIN (NUMA) IN STABILIZED VOIDED URINE. THE ALERE NMP22 TEST KIT IS INDICATED AS AN AID 1) IN THE DIAGNOSIS OF PERSONS WITH SYMPTOMS OR RISK FACTORS FOR TRANSITIONAL CELL CANCER (TCC) OF THE BLADDER (CUT-OFF >= 7.5 U/ML) IN CONJUNCTION WITH, AND NOT IN LIEU OF, CURRENT STANDARD DIAGNOSTIC PROCEDURES, AND 2) IN MANAGEMENT OF PATIENTS OF TRANSITIONAL CELL CARCINOMA OF THE BLADDER, AFTER SURGICAL TREATMENT TO IDENTIFY THOSE PATIENTS WITH OCCULT OR RAPIDLY RECURRING TCC (CUT-OFF > 10 U/ML). TRADE NAME ALERE NMP22 URINE COLLECTION KIT, WITH THE FOLLOWING INTENDED USE: THE ALERE NMP22 URINE COLLECTION KIT IS INTENDED FOR THE COLLECTION, STABILIZATION, AND TRANSPORT OF HUMAN URINE WHICH WILL BE TESTED USING THE ALERE NMP22 TEST KIT.

    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