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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.
Classification Namesystem, test, tumor marker, monitoring, bladder
Generic Namefluorescence in situ hybridization(fish) reagents
Regulation Number866.6010
PMA NumberP030052
Date Received12/10/2003
Decision Date01/24/2005
Product Code
MMW[ Registered Establishments with MMW ]
Docket Number 05M-0130
Notice Date 04/12/2005
Advisory Committee Pathology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the urovysion bladder cancer kit. The device is indicated for: the urovysion bladder cancer kit (urovysion kit) is designed to detect aneuploidy for chromosomes 3, 7, 17 and loss of the 9p21 locus via fluorescence in situ hybridization (fish) in urine specimens from persons with hematuria suspected of having bladder cancer. Results from the urovysion kit are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014