PD-L1 IHC 28-8 pharmDx

Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

FDA Premarket Approval P150025

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the pd-l1 ihc 28-8 pharmdx. This device is indicated for the following:1) pd-l1 ihc 28-8 pharmdx is a qualitative immunohisto-chemical 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-squamous non-small cell lung cancer (nsclc) tissue using envision flex visualization system on autostainer link 48; 2) pd-l1 protein expression is defined as the percentage of tumor cells exhibiting positive membrane staining at any intensity; and3) pd-l1 expression as detected by pd-l1 ihc 28-8 pharmdx in non-squamous nsclc may be associated with enhanced survival from opdivo (nivolumab).

DevicePD-L1 IHC 28-8 pharmDx
Classification NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantDAKO NORTH AMERICA, INC.
Date Received2015-07-09
Decision Date2015-10-09
Notice Date2015-11-02
PMAP150025
SupplementS
Product CodePLS
Docket Number15M-4016
Advisory CommitteePathology
Expedited ReviewNo
Combination Product No
Applicant Address DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P150025Original Filing
S015 2022-06-17 30-day Notice
S014 2021-07-12 Normal 180 Day Track
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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