| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | PD-L1 IHC 28-8 pharmDx |
|---|
| Generic Name | Immunohistochemistry assay, antibody, programmed death-ligand 1 |
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| Applicant | DAKO NORTH AMERICA, INC.
6392 VIA REAL
CARPINTERIA, CA 93013 |
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| PMA Number | P150027 |
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| Date Received | 08/04/2015 |
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| Decision Date | 01/23/2016 |
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|
APCB Date
|
03/13/2017 |
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| Product Code |
PLS |
| Docket Number | 16M-0803 |
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| Notice Date | 03/03/2016 |
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| Advisory Committee |
Pathology |
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| Clinical Trials | NCT01844505
|
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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 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 |
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| Labeling | Labeling
|
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| Supplements: |
S001 S002 S003 S004 |
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