BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P890064 · Supplement: S015 · Decision Jul 29, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    DIGENE HYBRID CAPTURE 2 HPV DNA TEST
    PMA Number
    P890064
    Supplement Number
    S015
    Device Class
    FDA Class 3
    Product Code
    MAQ
    Generic Name
    KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS
    Medical Specialty
    Unknown
    Advisory Committee
    Microbiology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 29, 2004
    Date Received
    May 28, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR REVISIONS TO THE ASSAY'S LABELING PERFORMANCE CHARACTERISTICS SECTION. THE CHANGE INVOLVES MOVING THE SECTION "RELATIVE FALSE-POSITIVE AND FALSE-NEGATIVE RATE" FROM THE LABELING'S CLINICAL PERFORMANCE SECTION TO THE ANALYTICAL SECTION WITH NARRATIVE REVISIONS. THE NEW SECTION IS ENTITLED "EXTERNAL STUDY USING CLINICAL SPECIMENS." A NEW NOTE HAS BEEN ADDED TO THE CURRENT LABELING'S TABLE 10 REFERENCED TO SNIJDERS, PJF, VAN DE BRULE, AJC, AND MEIJER, CJLM, "THE CLINICAL RELEVANCE OF HUMAN PAPILLOMAVIRUS TESTING: RELATIONSHIP BETWEEN ANALYTICAL AND CLINICAL SENSITIVITY". J PATHOL 2003; 201: 1-6.

    Classifications

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

    Product Code Device Name
    MAQ Kit, Dna Detection, Human Papillomavirus