PD-L1 IHC 22C3 pharmDx

FDA Premarket Approval P150013 S021

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 the pd-l1 ihc 22c3 pharmdx as a companion diagnostic device to detect pd-l1 protein (tumor proportion score? 50%) in patients with non-small cell lung cancer (nsclc) for treatment with libtayo.

DevicePD-L1 IHC 22C3 pharmDx
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantAgilent Technologies, Inc.
Date Received2020-08-31
Decision Date2021-02-22
PMAP150013
SupplementS021
Product CodePLS 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Agilent Technologies, Inc. 5301 Stevens Creek Blvd santa Clara, CA 95051

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

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