Transfer the following manufacturing steps to a new building: purification of antibodies and proteins and manufacturing of antibodies and proteins labelled with biotin or ruthenium complex. In addition, lyophilization of bulk raw materials necessary for production of elecsys assays will be moved to another new building.
| Device | ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET |
| Classification Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2016-02-18 |
| Decision Date | 2016-03-16 |
| PMA | P990056 |
| Supplement | S023 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990056 | | Original Filing |
| S038 |
2021-10-18 |
30-day Notice |
| S037 |
2019-11-14 |
Normal 180 Day Track |
| S036 |
2019-01-29 |
Real-time Process |
| S035 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S034 |
2018-10-01 |
30-day Notice |
| S033 |
2018-04-17 |
Real-time Process |
| S032 |
2018-04-03 |
30-day Notice |
| S031 |
2018-03-01 |
Real-time Process |
| S030 | | |
| S029 |
2017-10-11 |
Real-time Process |
| S028 |
2017-07-31 |
Normal 180 Day Track |
| S027 |
2017-08-03 |
30-day Notice |
| S026 |
2017-05-24 |
30-day Notice |
| S025 |
2016-10-26 |
30-day Notice |
| S024 |
2016-09-07 |
Normal 180 Day Track No User Fee |
| S023 |
2016-02-18 |
30-day Notice |
| S022 |
2015-10-07 |
30-day Notice |
| S021 |
2014-04-04 |
Real-time Process |
| S020 |
2013-04-09 |
Real-time Process |
| S019 |
2012-11-30 |
30-day Notice |
| S018 | | |
| S017 |
2012-02-29 |
30-day Notice |
| S016 |
2012-01-31 |
135 Review Track For 30-day Notice |
| S015 |
2011-11-22 |
30-day Notice |
| S014 |
2011-08-01 |
Normal 180 Day Track |
| S013 |
2011-05-03 |
Normal 180 Day Track No User Fee |
| S012 |
2011-04-25 |
30-day Notice |
| S011 |
2011-04-11 |
135 Review Track For 30-day Notice |
| S010 |
2009-10-07 |
135 Review Track For 30-day Notice |
| S009 |
2008-09-02 |
30-day Notice |
| S008 |
2008-03-28 |
Normal 180 Day Track |
| S007 |
2007-08-22 |
Normal 180 Day Track |
| S006 |
2006-12-28 |
30-day Notice |
| S005 | | |
| S004 |
2006-10-05 |
Real-time Process |
| S003 |
2006-02-13 |
Normal 180 Day Track |
| S002 |
2006-01-23 |
Special (immediate Track) |
| S001 |
2001-10-09 |
Normal 180 Day Track |
NIH GUDID Devices