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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DevicePD-L1 IHC 22C3 pharmDx
Classification Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
Generic Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
Applicant
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria, CA 93013
PMA NumberP150013
Supplement NumberS006
Date Received04/19/2017
Decision Date09/22/2017
Product Code
PLS[ Registered Establishments with PLS ]
Docket Number 17M-5929
Notice Date 10/23/2017
Advisory Committee Pathology
Clinical Trials NCT02335411
Supplement Typepanel track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for the PD-L1 IHC 22C3 pharmDx for expanding the indications to include gastric cancer patients. This device is indicated for the followingPD-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) and gastric or gastroesophageal junction (GEJ) adenocarcinoma tissues using EnVision FLEX visualization system on Autostainer Link 48. Non-Small Cell Lung Cancer (NSCLC)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. The specimen should be considered to have PD-L1 expression if TPS ?1% and high PD-L1 expression if TPS ?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.Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma PD-L1 protein expression in gastric or GEJ adenocarcinoma 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 . The specimen should be considered to have PD-L1 expression if CPS ? 1.PD-L1 IHC 22C3 pharmDx is indicated as an aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA® (pembrolizumab).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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