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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.
 
DevicePD-L1 IHC 22C3 PHARMDX
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd
Santa Clara, CA 95051
PMA NumberP150013
Date Received04/06/2015
Decision Date10/02/2015
Product Code PLS 
Docket Number 15M-3520
Notice Date 11/02/2015
Advisory Committee Pathology
Clinical TrialsNCT01295827
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PD-L1 IHC 22C3 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING: PD-L1 IHC 22C3 PHARMDX IS A QUALITATIVE IMMUNOHISTOCHEMICAL ASSAY USING MONOCLONAL MOUSE ANTI-PD-L1, CLONE 22C3 ANTIBODY INTENDED FOR USE IN THE DETECTION OF PD-L1PROTEIN IN FORMALIN FIXED, PARAFFIN EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48. PD-L1 PROTEIN EXPRESSION IS DETERMINED BY USING TUMOR PROPORTION SCORE (TPS), WHICH IS THE PERCENTAGE OF VIABLE TUMOR CELLS SHOWING PARTIAL OR COMPLETE MEMBRANE STAINING. THE SPECIMEN SHOULD BE CONSIDERED PD-L1 POSITIVE IF TPS >= 50% OF THE VIABLE TUMOR CELLS EXHIBIT MEMBRANE STAINING AT ANY INTENSITY. PD-L1 IHC 22C3 PHARMDX IS INDICATED AS AN AID IN IDENTIFYING NSCLC PATIENTS FOR TREATMENT WITH KEYTRUDA (PEMBROLIZUMAB).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S005 S006 S011 S001  S002 S004 S003 S015 S016 S019 S022 
S020 S024 S027 S007 S008 S009 S010 S013 S014 S018 S017 S021 
S012 S025 S026 S023 S029 S030 
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