• 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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
DevicePD-L1 IHC NIVOLUMAB PHARMDX
Classification Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
Generic Nameimmunohistochemistry assay, antibody, programmed death-ligand 1
Regulation Number864.1860
Applicant
DAKO NORTH AMERICA, INC.
6392 via real
carpinteria, CA 93013
PMA NumberP150027
Date Received08/04/2015
Decision Date01/23/2016
APCB Date 03/13/2017
Product Code
PLS[ Registered Establishments with PLS ]
Docket Number 16M-0803
Notice Date 03/03/2016
Advisory Committee Pathology
Clinical Trials NCT01844505
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE PD-L1 IHC 28-8 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING:PD-L1 IHC 28-8 PHARMDX IS A QUALITATIVE IMMUNOHISTOCHEMICAL ASSAY USING MONOCLONAL RABBIT ANTI-PD-L1, CLONE 28-8 INTENDED FOR USE IN THE DETECTION OF PD-L1 PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SQUAMOUS NON SMALL CELL LUNG CANCER (NSCLC) AND MELANOMA TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48. PD-L1 PROTEIN EXPRESSION IS DEFINED AS THE PERCENTAGE OF TUMOR CELLS EXHIBITING POSITIVE MEMBRANE STAINING AT ANY INTENSITY. PD-L1 EXPRESSION AS DETECTED BY PD-L1 IHC PHARMDX IN NONSQUAMOUS NSCLC MAY BE ASSOCIATED WITH ENHANCED SURVIVAL FROM OPDIVO® (NIVOLUMAB).POSITIVE PD-L1 STATUS AS DETERMINED BY PD-L1 IHC 28-8 PHARMDX IN MELANOMA IS CORRELATED WITH THE MAGNITUDE OF THE TREATMENT EFFECT ON PROGRESSION-FREE SURVIVAL FROM OPDIVO®.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S002 S003 
-
-