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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.
 
DeviceDAKO TOP2A FISH PHARMDX KIT
Generic NameFluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
ApplicantDAKO DENMARK A/S
42 PRODUKTIONSVEJ
2600 GLOSTRUP DK-26-2600
PMA NumberP050045
Date Received11/30/2005
Decision Date01/11/2008
Withdrawal Date 01/24/2018
Product Code NXG 
Docket Number 08M-0182
Notice Date 03/20/2008
Advisory Committee Pathology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TOP2A FISH PHARMDX KIT. THE DEVICE IS INDICATED FOR: TOP2A FISH PHARMDX KIT IS DESIGNED TO DETECT AMPLIFICATIONS AND DELETIONS (COPY NUMBER CHANGES) OF THE TOP2A GENE USING FLUORESCENCE IN SITU HYBRIDIZATION (FISH) TECHNIQUE ON FORMALIN-FIXED, PARAFFIN-EMBEDDED HUMAN BREAST CANCER TISSUE SPECIMENS. DELETIONS AND AMPLIFICATIONS OF THE TOP2A GENE SERVE AS A MARKER FOR POOR PROGNOSIS IN HIGH-RISK BREAST CANCER PATIENTS. RESULTS FROM THE TOP2A FISH PHARMDX KIT ARE INTENDED FOR USE AS AN ADJUNCT TO EXISTING CLINICAL AND PATHOLOGICAL INFORMATION.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S003  S001 S002 S004 
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