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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 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 NumberS003
Date Received12/22/2016
Decision Date09/15/2017
Product Code PLS 
Docket Number 17M-5813
Notice Date 09/29/2017
Advisory Committee Pathology
Clinical TrialsNCT02105636
Supplement TypePanel Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the PD-L1 IHC 28-8 pharmDx for expanding the indications to squamous cell carcinoma of the head and neck, and urothelial cancer patients. This device is indicated for the following: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-squamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), and melanoma 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. Tumor PD-L1 status is defined by indication specific staining interpretation. Tumor Indication* Intended Use PD-L1 Expression Clinical Cut off nsNSCLC PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous NSCLC and SCCHN may be associated with enhanced survival from OPDIVO® (nivolumab). >=1%, >=5%, >=10% SCCHN >=1% UC PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in UC may be associated with enhanced response rate from OPDIVO®. >=1% Melanoma 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®. >=1% *For details on staining interpretation, refer to section 13 of the product insert and indication specific PD-L1 IHC 28-8 pharmDx Interpretation Manuals.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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