VENTANA PD-L1(SP142) CDX ASSAY

Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

FDA Premarket Approval P160002 S006

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.

Pre-market Approval Supplement Details

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.

DeviceVENTANA PD-L1(SP142) CDX ASSAY
Classification NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantVENTANA MEDICAL SYSTEMS, INC.
Date Received2018-06-14
Decision Date2018-07-02
PMAP160002
SupplementS006
Product CodePLS
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address VENTANA MEDICAL SYSTEMS, INC. 1910 East Innovation Park Dr. tucson, AZ 85755

Supplemental Filings

Supplement NumberDateSupplement Type
P160002Original Filing
S019 2022-10-14 30-day Notice
S018 2022-07-12 30-day Notice
S017 2022-02-16 Special (immediate Track)
S016 2022-01-28 135 Review Track For 30-day Notice
S015 2021-09-07 Special (immediate Track)
S014 2021-02-22 Real-time Process
S013 2020-08-26 Real-time Process
S012 2020-01-21 Normal 180 Day Track
S011 2020-01-13 Real-time Process
S010 2019-08-22 Real-time Process
S009 2018-09-14 Panel Track
S008
S007 2018-06-18 Real-time Process
S006 2018-06-14 Normal 180 Day Track
S005
S004
S003 2017-07-17 30-day Notice
S002 2017-03-16 Normal 180 Day Track No User Fee
S001 2016-09-01 Normal 180 Day Track No User Fee

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