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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.
 
DeviceVYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK
Generic NameFluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
ApplicantABBOTT MOLECULAR, INC.
1300 EAST TOUHY AVENUE
DES PLAINES, IL 60018
PMA NumberP110012
Date Received04/01/2011
Decision Date08/26/2011
Product Code OWE 
Docket Number 11M-0630
Notice Date 09/06/2011
Advisory Committee Pathology
Clinical TrialsNCT00585195
Expedited Review Granted? Yes
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE VYSIS ALK BREAK APART FISH PROBE KIT; VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT; PROBECHEK ALK NEGATIVE CONTROL SLIDES; AND PROBECHEK ALK POSITIVE CONTROL SLIDES. THIS DEVICE IS INDICATED FOR: 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) NON-SMALL CELL LUNG CANCER (NSCLC) TISSUE SPECIMENS TO AID IN IDENTIFYING THOSE PATIENTS ELIGIBLE FOR TREATMENT WITH XALKORI CRIZOTINIB). THE TEST IS FOR PRESCRIPTION USE ONLY. THE VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT IS USED TO PREPARE PARAFFIN-EMBEDDED LUNG CANCER TISSUE SECTIONS FIXED ON POSITIVELY CHARGED SLIDES FOR USE IN FLUORESCENCE IN SITU HYBRIDIZATION (FISH) WITH VYSIS DNA FISH PROBES.THE PROBECHEK ALK NEGATIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK NEGATIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK POSITIVE CONTROL SLIDES ARE INTENDED FOR USE AS AN ASSAY CONTROL FOR APPROPRIATE HYBRIDIZATION CONDITIONS DURING ROUTINE USE OF THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020). THE PROBECHEK ALK POSITIVE CONTROL SLIDES SHOULD BE ASSAYED IN CONJUNCTION WITH THE USER'S SPECIMEN SLIDES ACCORDING THE PACKAGE INSERT FOR THE VYSIS ALK BREAK APART FISH PROBE KIT (LIST NO. 06N38-020).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 
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