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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.
DeviceVysis ALK Break Apart Fish Probe Kit
Generic NameFluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
PMA NumberP110012
Supplement NumberS020
Date Received12/23/2019
Decision Date05/22/2020
Product Code OWE 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of the expansion of the Indications for Use for the Vysis ALK Break Apart FISH Probe Kit to include an indication for ALUNBRIG® (brigatinib). The device, as modified, will be marketed under the trade name Vysis ALK Break Apart FISH Probe Kit and is indicated for:INTENDED USE The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) tissue specimens from non-small cell lung cancer (NSCLC) patients.INDICATION FOR USEThe Vysis ALK Break Apart FISH Probe Kit is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) and ALUNBRIG® (brigatinib) in accordance with the approved therapeutic product labeling.