Approval for the elecsys(r) total psa immunoassay and elecsys(r) total psa calset. The device, a quantitative in vitro diagnostic test for total prostate-specific antigen (tpsa) in human serum and plasma is indicated for the measurement of total psa in conjunction with dogota; rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of prostate cancer. The test id further indicated for serial measurement of tpsa to aid in the management of prostate cancer patients. The electochemiluminescence immunoassay "eclia" is intended for use on the roche elecsys(r) 1010 and 2010 immunoassay analyzers.
| 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 | 1999-10-04 |
| Decision Date | 2000-11-22 |
| Notice Date | 2000-12-12 |
| PMA | P990056 |
| Supplement | S |
| Product Code | MTF |
| Docket Number | 00M-1660 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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