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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
Classification Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
Generic Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
Applicant
VENTANA MEDICAL SYSTEMS, INC.
1910 east innovation park dr.
tucson, AZ 85755
PMA NumberP160002
Date Received01/13/2016
Decision Date05/18/2016
Product Code
PLS[ Registered Establishments with PLS ]
Docket Number 16M-1400
Notice Date 06/03/2016
Advisory Committee Pathology
Clinical Trials NCT02108652
NCT02302807
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 S006 S007 S009 
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