BEUDAMED
    Product Code: QKF FDA class 3 21 CFR 864.1860

    Immunocytochemistry Assay, P16/Ki-67

    Hematology

    The Immunocytochemistry Assay, P16/Ki-67 is a Class 3 in vitro diagnostic device consisting of a qualitative immunocytochemical assay that simultaneously detects the p16INK4a and Ki-67 proteins in clinician-collected cervical specimens, intended to aid in the evaluation of cervical cancer risk. It requires Premarket Approval (PMA) and is regulated under 21 CFR 864.1860 within the Hematology medical specialty, reviewed by the Pathology panel. The product code is QKF. The device is not an implant and is not flagged as life-sustaining.

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    510(k)s
    0
    FEI Numbers
    1
    Registration Numbers
    1
    Unique Applicants
    0
    Years Active
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    Basic Information

    Product Code
    QKF
    Device Class
    FDA class 3
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Review Panel
    PA
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    The p16 and Ki-67 antibody cocktail is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a (E6H4) and Ki-67 (274-11AC3V1) proteins in cervical specimens collected by a clinician.

    FEI Numbers

    This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.