| 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. |
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| Device | PD-L1 IHC 28-8 pharmDx |
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| Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
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| Applicant | Agilent Technologies, Inc.
5301 Stevens Creek Blvd
Santa Clara, CA 95051 |
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| PMA Number | P150025 |
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| Supplement Number | S005 |
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| Date Received | 12/29/2016 |
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| Decision Date | 05/03/2017 |
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| Product Code |
PLS |
| Advisory Committee |
Pathology |
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| Supplement Type | Normal 180 Day Track No User Fee |
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| Supplement Reason | Labeling Change - PAS |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
Approval for the device which will be marketed under the trade name PD-L1 IHC 28 - 8 pharmDx and is indicated for 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 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. PD-L1 expression as detected by PD-L1 IHC 28-8 pharmDx in non-squamous 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®. |
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