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Premarket Approval (PMA)

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DeviceKi-67 IHC pharmDx
Generic NameImmunohistochemistry assay, antibody, Ki-67
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Boulevard
Santa Clara, CA 95051
PMA NumberP210026
Date Received06/30/2021
Decision Date10/12/2021
Product Code QQT 
Advisory Committee Pathology
Clinical TrialsNCT03155997
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of Ki-67 IHC MIB-1 pharmDx (Dako Omnis)For In Vitro Diagnostic Use.Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is a qualitative immunohistochemical (IHC) assay using monoclonal mouse anti-Ki-67, Clone MIB-1, intended for use in the detection of Ki-67 protein in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue using the EnVision FLEX visualization system on Dako Omnis.Ki-67 protein expression in breast carcinoma is determined by using the Ki-67 pharmDx Score, which is the overall percentage of viable tumor cells in the invasive cancer component showing Ki-67 nuclear staining. The specimen should be considered to have Ki-67 expression if Ki-67 pharmDx Score is ? 20.Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is indicated as an aid in identifying patients with early breast cancer at high risk of disease recurrence for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness