| 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 22C3 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 | P150013 |
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| Date Received | 04/06/2015 |
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| Decision Date | 10/02/2015 |
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| Product Code |
PLS
|
| Docket Number | 15M-3520 |
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| Notice Date | 11/02/2015 |
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| Advisory Committee |
Pathology |
|---|
| Clinical Trials |
NCT01295827
|
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| Expedited Review Granted? | Yes |
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| Combination Product |
No
|
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Approval Order Statement
APPROVAL FOR THE PD-L1 IHC 22C3 PHARMDX. THIS DEVICE IS INDICATED FOR THE FOLLOWING: PD-L1 IHC 22C3 PHARMDX IS A QUALITATIVE IMMUNOHISTOCHEMICAL ASSAY USING MONOCLONAL MOUSE ANTI-PD-L1, CLONE 22C3 ANTIBODY INTENDED FOR USE IN THE DETECTION OF PD-L1PROTEIN IN FORMALIN FIXED, PARAFFIN EMBEDDED (FFPE) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE USING ENVISION FLEX VISUALIZATION SYSTEM ON AUTOSTAINER LINK 48. PD-L1 PROTEIN EXPRESSION IS DETERMINED BY USING TUMOR PROPORTION SCORE (TPS), WHICH IS THE PERCENTAGE OF VIABLE TUMOR CELLS SHOWING PARTIAL OR COMPLETE MEMBRANE STAINING. THE SPECIMEN SHOULD BE CONSIDERED PD-L1 POSITIVE IF TPS >= 50% OF THE VIABLE TUMOR CELLS EXHIBIT MEMBRANE STAINING AT ANY INTENSITY. PD-L1 IHC 22C3 PHARMDX IS INDICATED AS AN AID IN IDENTIFYING NSCLC PATIENTS FOR TREATMENT WITH KEYTRUDA (PEMBROLIZUMAB). |
| Approval Order |
Approval Order
|
| Summary |
Summary of Safety and Effectiveness |
| Labeling |
Labeling
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| Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008
S009 S010 S011 S012 S013 S014 S015 S016 |
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