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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
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
LabelingLabeling
Supplements:  S001 S002 
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