Eliminate a second clone identity testing procedure at the fermentation stage for lsi 9p21, qualify the geneprep instrument, qualify the overheadmixing system and validation of mixing process in the manufacture of hybridization buffer,implement the optical density reading as an additional in process quality control, validate anexisting mixing process for the urovysion bulk solution, and transfer an existing in-process testing of labeled dna.
| Device | UROVYSION BLADDER CANCER KIT ASSAY |
| Classification Name | Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Generic Name | Test, Fluorescence In Situ Hybridization (fish), For Bladder Cancer Detection And Monitoring For Recurrence |
| Applicant | ABBOTT MOLECULAR |
| Date Received | 2012-07-13 |
| Decision Date | 2012-08-10 |
| PMA | P030052 |
| Supplement | S009 |
| Product Code | NSD |
| Advisory Committee | Pathology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT MOLECULAR 1300 E. Touhy Avenue des Plaines, IL 60018 |
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