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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(SP142) CDX ASSAY
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON, AZ 85755
PMA NumberP160002
Date Received01/13/2016
Decision Date05/18/2016
Product Code PLS 
Docket Number 16M-1400
Notice Date 06/03/2016
Advisory Committee Pathology
Clinical TrialsNCT02108652
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the PD-L1(SP142) Assay. The device is indicated for the following: VENTANA PD-L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD-L1 clone SP142 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 and OptiView Amplifcation Kit on a VENTANA BenchMark ULTRA instrument. PD-L1 status is determined by the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity. PD-L1 expression in >= 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is associated with increased objective response rate (ORR) in a non-randomized study of TECENTRIQ (atezolizumab).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S006 S007 S009 S010 S011 S012 S013 S014 
S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 
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