BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Kit, Dna Detection, Human Papillomavirus

    PMA: P890064 · Supplement: S013 · Decision Nov 7, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Kit, Dna Detection, Human Papillomavirus
    Trade Name
    HYBRID CAPTURE 2 HIGH-RISK HPV DNA TEST AND HYBRID CAPTURE HPV DNA TEST
    PMA Number
    P890064
    Supplement Number
    S013
    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
    November 7, 2003
    Date Received
    October 1, 2003
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR: 1) MODIFICATION OF HYBRIDIZATION PROCEDURAL STEPS AND SEQUENCE; THIS MODIFICATION ENTAILS REVERSING THE ADDITION ORDER OF THE HPV RNA PROBES AND DENATURED SPECIMEN WITH NO CHANGE IN PROBE OR SPECIMEN VOLUME. AN ADDITIONAL 10 MINUTE INCUBATION PERIOD AT ROOM TEMPERATURE (15 DEGREES C TO 30 DEGREES C) WAS ADDED AFTER REMOVAL OF THE SPECIMEN FROM THE 65 += 2 DEGREES C, 60 MINUTES HYBRIDIZATION INCUBATION STEP. 2) ADDITION OF AN EQUIVOCAL RESULT ZONE, WHICH REQUIRES REPEATING SPECIMENS THAT HAVE RESULTS WITHIN THIS RESULT ZONE, FOR SPECIMENS COLLECTED IN PRESERVCYT TRANSPORT MEDIUM. THIS EQUIVOCAL RESULT ZONE HAS BEEN ESTABLISHED TO BE >=1.0 AND <+ 2.5 RLU/CO. 3)_ REMOVAL OF THE EQUIVOCAL RESULT ZONE FROM SPECIMENS COLLECTED IN THE DIGENE SPECIMEN TRANSPORT MEDIUM.

    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