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.
| Device | UROVYSION BLADDER CANCER KIT |
| Applicant | ABBOTT MOLECULAR |
| Date Received | 2003-12-10 |
| Decision Date | 2005-01-24 |
| Notice Date | 2005-04-12 |
| PMA | P030052 |
| Supplement | S |
| Docket Number | 05M-0130 |
| Advisory Committee | Pathology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR 1300 E. Touhy Avenue des Plaines, IL 60018 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P030052 | | Original Filing |
| S028 |
2022-02-18 |
30-day Notice |
| S027 |
2020-11-16 |
30-day Notice |
| S026 |
2019-07-31 |
30-day Notice |
| S025 |
2019-04-10 |
30-day Notice |
| S024 |
2018-08-10 |
30-day Notice |
| S023 |
2018-06-15 |
30-day Notice |
| S022 |
2018-02-16 |
30-day Notice |
| S021 |
2017-11-08 |
30-day Notice |
| S020 |
2016-11-22 |
Real-time Process |
| S019 |
2016-09-12 |
30-day Notice |
| S018 |
2016-09-02 |
30-day Notice |
| S017 |
2015-11-12 |
135 Review Track For 30-day Notice |
| S016 |
2014-07-24 |
30-day Notice |
| S015 |
2014-06-16 |
30-day Notice |
| S014 |
2013-11-25 |
30-day Notice |
| S013 |
2013-11-05 |
30-day Notice |
| S012 |
2013-08-29 |
Normal 180 Day Track No User Fee |
| S011 |
2013-01-16 |
30-day Notice |
| S010 |
2012-10-25 |
Special (immediate Track) |
| S009 |
2012-07-13 |
30-day Notice |
| S008 |
2011-06-23 |
30-day Notice |
| S007 |
2011-05-06 |
30-day Notice |
| S006 |
2011-04-28 |
Special (immediate Track) |
| S005 |
2011-03-18 |
30-day Notice |
| S004 |
2011-02-25 |
Special (immediate Track) |
| S003 |
2009-01-26 |
30-day Notice |
| S002 |
2007-01-08 |
Real-time Process |
| S001 |
2005-06-20 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices