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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) 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 NumberS009
Date Received09/14/2018
Decision Date03/08/2019
Product Code
PLS[ Registered Establishments with PLS ]
Docket Number 19M-1310
Notice Date 03/20/2019
Advisory Committee Pathology
Clinical Trials NCT02425891
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for VENTANA PD L1 (SP142) Assay is a qualitative immunohistochemical assay using rabbit monoclonal anti-PD L1 clone SP142. The device is intended for use in the assessment of the programmed death-ligand 1 (PD-L1) protein in tumor cells and tumor-infiltrating immune cells in the formalin-fixed, paraffin-embedded (FFPE) tissues indicated below 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.VENTANA PD-L1 (SP142) Assay is indicated as an aid for identifying patients for treatment with the therapies for the respective cutoffs listed in Table 1 in accordance with the approved therapeutic product labeling. Table 1. Companion diagnostic indications for the VENTANA PD-L1 (SP142) Assay Indication for use Therapy Cutoff Urothelial Carcinoma TECENTRIQ >= 5% ICTriple-Negative Breast Carcinoma (TNBC) TECENTRIQ >= 1% ICPD-L1 expression in >= 50% TC or >= 10% IC determined by VENTANA PD-L1 (SP142) Assay in non-small cell lung cancer (NSCLC) patients may be associated with enhanced overall survival from TECENTRIQ (atezolizumab).This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. This product is intended for in vitro diagnostic (IVD) use.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
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