PMA P160002S009
- Device
- VENTANA PD-L1(SP142) Assay.
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S009
- Product code
- PLS
- Decision date
- 2019-03-08
- Classification
- Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf16/P160002S009B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- VENTANA PD-L1(SP142) Assay.
- Applicant
- Ventana Medical Systems, Inc.
- PMA number
- P160002
- Supplement
- S009
- Product code
- PLS
- Generic name
- Immunohistochemistry assay, antibody, programmed death-ligand 1
- Decision date
- 2019-03-08
- Decision code
- APPR
- Date received
- 2018-09-14
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.