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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.
 
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
Supplement NumberS006
Date Received06/14/2018
Decision Date07/02/2018
Product Code
PLS[ Registered Establishments with PLS ]
Advisory Committee Pathology
Clinical Trials NCT02807636
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifying the intended use of the VENTANA PD-L1(SP142). The 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 and non-small cell lung cancer (NSCLC) tissue stained with OptiView DAB IHC Detection Kit and OptiView Amplification Kit on a VENTANA BenchMark ULTRA instrument. Determination of PD-L1 status is indication-specific, and evaluation is based on either the proportion of tumor area occupied by PD-L1 expressing tumor-infiltrating immune cells (% IC) of any intensity or the percentage of PD-L1 expressing tumor cells (% TC) of any intensity.PD-L1 expression in >= 5% IC determined by VENTANA PD-L1 (SP142) Assay in urothelial carcinoma tissue is indicated as an aid in identifying urothelial carcinoma patients for treatment with TECENTRIQ (atezolizumab).PD-L1 expression in >= 50% TC or >= 10% IC determined by VENTANA PD-L1 (SP142) Assay in NSCLC tissue may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).See the TECENTRIQ® product label for PD-L1 expression cutoff values guiding therapy in specific clinical circumstances.This product is intended for in vitro diagnostic (IVD) use.
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