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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.
 
DeviceVENTANA PD-L1 (SP263) ASSAY
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantVentana Medical Systems, Inc.
1910 E. Innovation Park Dr.
Tucson, AZ 85755
PMA NumberP160046
Date Received10/20/2016
Decision Date05/01/2017
Product Code PLS 
Docket Number 17M-2768
Notice Date 05/02/2017
Advisory Committee Pathology
Clinical TrialsNCT01693562
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the VENTANA PD-L1 (SP263) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP263 intended for use in the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) urothelial carcinoma tissue stained with OptiView DAB IHC Detection Kit on a VENTANA BenchMark ULTRA instrument.PD-L1 status is determined by the percentage of tumor cells with any membrane staining above background or by the percentage of tumor-associated immune cells with staining (IC+) at any intensity above background. The percent of tumor area occupied by any tumor-associated immune cells (Immune Cells Present, ICP) is used to determine IC+, which is the percent area of ICP exhibiting PD-L1 positive immune cell staining. PD-L1 status is considered High if any of the following are met:1) >= 25% of tumor cells exhibit membrane staining; or,2) ICP > 1% and IC+ ? 25%; or,3) ICP = 1% and IC+ = 100%.PD-L1 High status as determined by VENTANA PD-L1 (SP263) Assay was associated with increased objective response rate (ORR) in a single arm study of IMFINZI (durvalumab).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S019 
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