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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceVENTANA ALK (D5F3) CDx Assay
Generic NameImmunohistochemistry assay, antibody, anaplastic lymphoma kinase
ApplicantVentana Medical Systems, Inc.
1910 E Innovation Park Dr.
Tucso, AZ 85755
PMA NumberP140025
Supplement NumberS006
Date Received06/07/2017
Decision Date11/06/2017
Product Code PKW 
Advisory Committee Pathology
Clinical TrialsNCT02075840
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the VENTANA ALK (D5F3) CDx Assay. The device 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 or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) or ZYKADIA® (ceritinib) or ALECENSA® (alectinib).
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