PD-L1 IHC 22C3 PHARMDX

Immunohistochemistry Assay, Antibody, Programmed Death-ligand 1

FDA Premarket Approval P150013 S001

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 pd-l1 ihc 22c3 pharmdx is a qualitative immunohistochemical assay using monoclonal mouse anti-pd-l1, clone 22c3 intended for use in the detection of pd-l1 protein in formalin-fixed, paraffin-embedded (ffpe) non-small cell lung cancer (nsclc) tissue using envision flex visualization system on autostainer link 48. Pd-l1 protein expression is determined by using tumor proportion score (tps), which is the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The specimen should be considered to have pd-l1 expression if tps greater than or equal to 1% and high pd-l1 expression if tps is greater than or equal to 50%. Pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying nsclc patients for treatment with keytruda® (pembrolizumab). See the keytruda® product label for expression cutoff values guiding therapy in specific clinical circumstances. This device is for in vitro diagnostic use.

DevicePD-L1 IHC 22C3 PHARMDX
Classification NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantDAKO NORTH AMERICA, INC.
Date Received2015-12-31
Decision Date2016-10-24
Notice Date2016-11-28
PMAP150013
SupplementS001
Product CodePLS
Docket Number16M-3913
Advisory CommitteePathology
Supplement TypePanel Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewYes
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
P150013Original Filing
S025 2022-08-08 Real-time Process
S024 2022-01-31 Special (immediate Track)
S023 2021-11-17 Special (immediate Track)
S022
S021 2020-08-31 Normal 180 Day Track
S020 2020-06-29 Panel Track
S019 2020-02-06 Normal 180 Day Track No User Fee
S018 2019-09-05 Normal 180 Day Track No User Fee
S017 2019-06-14 Normal 180 Day Track
S016 2019-02-25 Panel Track
S015 2019-02-15 30-day Notice
S014
S013 2018-12-21 30-day Notice
S012
S011 2018-06-25 Panel Track
S010 2018-03-12 30-day Notice
S009 2018-01-29 Panel Track
S008 2017-12-26 30-day Notice
S007 2017-09-21 Normal 180 Day Track No User Fee
S006 2017-04-19 Panel Track
S005 2017-04-17 30-day Notice
S004 2016-12-27 Real-time Process
S003 2016-08-19 Real-time Process
S002 2016-06-28 Real-time Process
S001 2015-12-31 Panel Track

NIH GUDID Devices

Device IDPMASupp
05700571107300 P150013 000
05700573003563 P150013 000
05700571112755 P150013 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.