BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Immunocytochemistry Assay, P16/Ki-67

    PMA: P190024 · Decision Mar 10, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1

    Basic Information

    Device Name
    Immunocytochemistry Assay, P16/Ki-67
    Trade Name
    CINtec PLUS Cytology
    PMA Number
    P190024
    Device Class
    FDA Class 3
    Product Code
    QKF
    Generic Name
    Immunocytochemistry assay, p16/Ki-67
    Regulation Number
    864.1860
    Medical Specialty
    Hematology
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 10, 2020
    Date Received
    September 12, 2019
    Expedited Review
    N
    Docket Number
    20M-1083

    Advisory Committee Statement

    Approval for The CINtec® PLUS Cytology test. The device is a qualitative immunocytochemical assay intended for the simultaneous detection of the p16INK4a and Ki-67 proteins in cervical specimens collected by a clinician using an endocervical brush/spatula or broom collection device and placed in the ThinPrep® Pap Test PreservCyt® Solution. The CINtec PLUS Cytology test includes a ready-to-use cocktail of primary antibodies which contains a mouse monoclonal antibody directed against human p16INK4a (p16) protein (clone E6H4), and a recombinant rabbit monoclonal antibody directed against human Ki-67 protein (clone 274-11AC3V1) for use on the BenchMark ULTRA instrument with 3,3-diaminobenzidine tetrahydrochloride (DAB) and Fast Red detection systems.The CINtec PLUS Cytology test is indicated:1) To be used in women 25 - 65 years old with 12 Other High Risk (HR) HPV positive test results using the cobas® 4800 HPV Test in primary HPV screening, to determine the need for referral to colposcopy.To be used in women 25 - 65 years old with HPV16/18 positive test results using the cobas® 4800 HPV Test in primary HPV screening where the CINtec PLUS Cytology test results will be used in conjunction with the physicians assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.2) To be used in women 30 - 65 years old with NILM (Negative for Intraepithelial Lesion or Malignancy) and 12 Other HR HPV positive test results using the cobas 4800 HPV Test in adjunctive cervical cytology and HR HPV screening, to determine the need for referral to colposcopy.To be used in women 30 - 65 years old with NILM (Negative for Intraepithelial Lesion or Malignancy) and HPV16/18 positive test results using the cobas® 4800 HPV Test in adjunctive cervical cytology and HR HPV screening where the CINtec PLUS Cytology test results will be used in conjunction with the physicians assessment of patient screening history, other risk factors, and professional guidelines to guide patient management.Results from the CINtec PLUS Cytology test should be interpreted by a qualified pathologist.

    Classifications

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

    Product Code Device Name
    QKF Immunocytochemistry Assay, P16/Ki-67