Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 28-8 pharmDx
Generic NameImmunohistochemistry assay, antibody, programmed death-ligand 1
ApplicantAgilent Technologies, Inc.
5301 Stevens Creek Blvd
Santa Clara, CA 95051
PMA NumberP150025
Supplement NumberS013
Date Received12/16/2019
Decision Date05/15/2020
Product Code PLS 
Docket Number 20M-1410
Notice Date 05/20/2020
Advisory Committee Pathology
Clinical TrialsNCT02477826
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval application (PMA) supplement submitted to expand the indication for the PD-L1 IHC 28-8 pharmDx to include detection of PD-L1 protein in NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab). The device, as modified, will be marketed under the trade name PD-L1 IHC 28-8 pharmDx and is indicated for in vitro diagnostic use.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-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), and urothelial carcinoma (UC) tissues using EnVision FLEX visualization system on Autostainer Link 48. PD-L1 protein expression is defined as the percentage of evaluable tumor cells exhibiting partial or complete membrane staining at any intensity. Companion Diagnostic Indication Tumor Indication PD-L1 Expression Clinical Cut Off Intended UseNSCLC >=1% tumor cell expression PD-L1 IHC 28-8 pharmDx is indicated as an aid in identifying NSCLC patients for treatment with OPDIVO® (nivolumab) in combination with YERVOY® (ipilimumab).PD-L1 expression (>=1% or ?5% or >=10% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC may be associated with enhanced survival from OPDIVO®.PD-L1 expression (>=1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in SCCHN may be associated with enhanced survival from OPDIVO®. PD-L1 expression (>=1% tumor cell expression), as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO®. See the OPDIVO® and YERYOV® product labels for specific clinical circumstances guiding PD-L1 testing.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
-
-