PD-L1 IHC 22C3 PharmDx

FDA Premarket Approval P150013 S018

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 labeling changes to include results from additional non-clinical studies that were conducted as specified in the june 12, 2018 approval letter for p150013/s009. The device will be marketed under the trade name pd-l1 ihc 22c3 pharmdx and is indicated for the following: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), gastric or gastroesophageal junction (gej) adenocarcinoma, esophageal squamous cell carcinoma (escc), cervical cancer, urothelial carcinoma and head and neck squamous cell carcinoma (hnscc) tissues using envision flex visualization system on autostainer link 48. Pd-l1 protein expression in nsclc 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. Pd-l1 protein expression in gastric or gej adenocarcinoma, escc, cervical cancer, urothelial carcinoma and hnscc is determined by using combined positive score (cps), which is the number of pd-l1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100. Tumor indication pd-l1 expression level intended usensclc tps? 1% pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying nsclc patients for treatment with keytruda® (pembrolizumab). **gastric or gej adenocarcinoma cps? 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying gastric or gej adenocarcinoma patients for treatment with keytruda® (pembrolizumab). Escc cps? 10 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying escc patients for treatment with keytruda® (pembrolizumab). Cervical cancer cps? 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying cervical cancer patients for treatment with keytruda® (pembrolizumab). Urothelial carcinoma cps? 10 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying urothelial carcinoma patients for treatment with keytruda® (pembrolizumab). **hnscc cps? 1 pd-l1 ihc 22c3 pharmdx is indicated as an aid in identifying hnscc patients for treatment with keytruda® (pembrolizumab). **for in vitro diagnostic use. 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), gastric or gastroesophageal junction (gej) adenocarcinoma, esophageal squamous cell carcinoma (escc), cervical cancer, urothelial carcinoma and head and neck squamous cell carcinoma (hnscc) tissues using envision flex visualization system on autostainer link 48. Pd-l1 protein expression in nsclc 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. Pd-l1 protein expression in gastric or gej adenocarcinoma, escc, cervical cancer, urothelial carcinoma and hnscc is determined by using combined positive score (cps), which is the number of pd-l1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.

DevicePD-L1 IHC 22C3 PharmDx
Generic NameImmunohistochemistry Assay, Antibody, Programmed Death-ligand 1
ApplicantDAKO NORTH AMERICA, INC.
Date Received2019-09-05
Decision Date2020-02-27
PMAP150013
SupplementS018
Product CodePLS 
Advisory CommitteePathology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLabeling Change - Pas
Expedited ReviewNo
Combination Product No
Applicant Address DAKO NORTH AMERICA, INC. 6392 Via Real carpinteria, CA 93013

Supplemental Filings

Supplement NumberDateSupplement Type
P150013Original Filing
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

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