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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceVENTANA ALK (D5F3) CDX ASSAY
Generic NameImmunohistochemistry assay, antibody, anaplastic lymphoma kinase
ApplicantVENTANA MEDICAL SYSTEMS, INC.
1910 EAST INNOVATION PARK DR.
TUCSON, AZ 85755
PMA NumberP140025
Date Received11/14/2014
Decision Date06/12/2015
Product Code PKW 
Docket Number 15M-2219
Notice Date 07/10/2015
Advisory Committee Pathology
Clinical TrialsNCT00585195
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE VENTANA ALK (D5F3) CDX ASSAY. THIS DEVICE IS INDICATED FOR THE FOLLOWING:VENTANA ALK (D5F3) CDX ASSAY IS INTENDED FOR THE QUALITATIVE DETECTION OF THE ANAPLASTIC LYMPHOMA KINASE (ALK) PROTEIN IN FORMALIN-FIXED, PARAFFIN-EMBEDDED (FFPE) NON-SMALL CELL LUNG CARCINOMA (NSCLC) TISSUE STAINED WITH A BENCHMARK XT AUTOMATED STAINING INSTRUMENT. IT IS INDICATED AS AN AID IN IDENTIFYING PATIENTS ELIGIBLE FOR TREATMENT WITH XALKORI® (CRIZOTINIB).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S005 S002 S001 S003 S006 S007 S004 S011 S013 S009 S010 
S012 S020 S016 S017 S015 S018 S014 S021 S022 S023 
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