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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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
Supplement NumberS001
Date Received12/31/2015
Decision Date10/24/2016
Product Code PLS 
Docket Number 16M-3913
Notice Date 11/28/2016
Advisory Committee Pathology
Clinical TrialsNCT01295827
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination ProductNo
Approval Order Statement  
Approval for PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein 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 at any intensity. The specimen should be considered to have PD-L1 expression if TPS greater than or equal to 1% and high PD-L1 expression if TPS is greater than or equal to 50%. PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with KEYTRUDA® (pembrolizumab). See the KEYTRUDA® product label for expression cutoff values guiding therapy in specific clinical circumstances. This device is for in vitro diagnostic use.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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