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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.
Generic Namefluorescence in situ hybridization, chromosome 17p deletion (tp53)
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP150041
Date Received10/30/2015
Decision Date04/11/2016
Product Code PNK 
Docket Number 16M-1167
Notice Date 05/11/2016
Advisory Committee Pathology
Clinical TrialsNCT01889186
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The Vysis CLL FISH Probe Kit is a test to detect deletion of the LSI TP53 probe target via fluorescence in situ hybridization (FISH) in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).The test is indicated for detecting deletion of the LSI TP53 probe target (17p-) as an aid in identifying those patients with CLL for whom treatment with VENCLEXTA® (venetoclax) is indicated. Vysis CLL FISH Probe Kit is not intended for monitoring of residual disease.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 S004 S005 S006