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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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
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
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