• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 NumberS014
Date Received01/18/2019
Decision Date06/10/2019
Product Code
PLS[ Registered Establishments with PLS ]
Docket Number 19M-3309
Notice Date 07/09/2019
Advisory Committee Pathology
Clinical Trials NCT02358031
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the PD-L1 IHC 22C3 pharmDx. This 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, 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, cervical cancer, urothelial carcinoma and HNSCC is determined by using Combined Positive Score (CPS), which is the number of PDL1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.Companion Diagnostic Indications 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).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 head and neck squamous cell carcinoma patients for treatment with KEYTRUDA® (pembrolizumab). * **See the KEYTRUDA® product label for specific clinical circumstances guiding PD-L1 testing.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
-
-