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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameVYSIS ALK BREAK APART FISH PROBE KIT, VYSIS PARAFFIN PRETREATMENT IV & POST HYBRIDIZATION WASH BUFFER KIT PROBECHEK ALK
Classification Namefluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP110012
Date Received04/01/2011
Decision Date08/26/2011
Product Code
OWE[ Registered Establishments with OWE ]
Docket Number 11M-0630
Notice Date 09/06/2011
Advisory Committee Pathology
Clinical Trials NCT00585195
NCT00932451
NCT00932893
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Supplements: S001 S002 S003 S004 S005 
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