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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
TUCSON, AZ 85755
PMA NumberP140025
Supplement NumberS014
Date Received11/16/2020
Decision Date03/03/2021
Product Code PKW 
Advisory Committee Pathology
Clinical TrialsNCT03052608
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for inclusion of an indication for LORBRENA ((lorlatinib). The device will be marketed under the trade name VENTANA ALK (D5F3) CDx Assay and is indicated for: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 or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib), or ALECENSA® (alectinib) or LORBRENA® (lorlatinib).This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.This product is intended for in vitro diagnostic (IVD) use.