PD-L1 IHC 28-8 pharmDx

FDA Premarket Approval P150025 S013

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

For in vitro diagnostic use. Pd-l1 ihc 28-8 pharmdx is a qualitative immunohistochemical assay using monoclonal rabbit anti-pd-l1, clone 28-8 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-small cell lung cancer (nsclc), squamous cell carcinoma of the head and neck (scchn), and urothelial carcinoma (uc) tissues using envision flex visualization system on autostainer link 48. Pd-l1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. Companion diagnostic indication tumor indication pd-l1 expression clinical cut off intended usensclc? 1% tumor cell expression pd-l1 ihc 28-8 pharmdx is indicated as an aid in identifying nsclc patients for treatment with opdivo® (nivolumab) in combination with yervoy® (ipilimumab). Pd-l1 expression (? 1% or? 5% or? 10% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in non-squamous nsclc may be associated with enhanced survival from opdivo®. Pd-l1 expression (? 1% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in scchn may be associated with enhanced survival from opdivo®. Pd-l1 expression (? 1% tumor cell expression), as detected by pd-l1 ihc 28-8 pharmdx in uc may be associated with enhanced response rate from opdivo®. See the opdivo® and yeryov® product labels for specific clinical circumstances guiding pd-l1 testing.

DevicePD-L1 IHC 28-8 pharmDx
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantDAKO NORTH AMERICA, INC.
Date Received2019-12-16
Decision Date2020-05-15
PMAP150025
SupplementS013
Product CodePLS 
Advisory CommitteePathology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013

Supplemental Filings

Supplement NumberDateSupplement Type
P150025Original Filing
S013 2019-12-16 Panel Track
S012
S011 2019-02-15 30-day Notice
S010 2018-12-21 30-day Notice
S009 2018-03-12 30-day Notice
S008 2017-12-26 30-day Notice
S007
S006 2017-04-17 30-day Notice
S005 2016-12-29 Normal 180 Day Track No User Fee
S004 2016-12-27 Real-time Process
S003 2016-12-22 Panel Track
S002 2016-08-19 Real-time Process
S001 2016-07-07 Real-time Process

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