Approval for the bayer immuno 1(tm) complexed psa assay. The in vitro device is intended to quantitatively measure complexed prostate-specific antigen (cpsa) in human serum on the bayer immuno 1(tm) system. This device is indicated for the measurement of serum complexed psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Biopsy of the prostate is required for the diagnosis of prostate cancer. This device is further indicated as an aid in the management (monitoring) of prostate cancer patients. This diagnostic method is not intended for use on any other system.
| Device | BAYER IMMUNO 1 COMPLEXED PSA ASSAY |
| Classification Name | Antigen(complexed),prostate Specific,(cpsa) |
| Generic Name | Antigen(complexed),prostate Specific,(cpsa) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 1999-10-01 |
| Decision Date | 2000-09-08 |
| Notice Date | 2000-09-26 |
| PMA | P990055 |
| Supplement | S |
| Product Code | NAF |
| Docket Number | 00M-1524 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P990055 | | Original Filing |
| S024 |
2022-03-22 |
30-day Notice |
| S023 |
2021-04-01 |
30-day Notice |
| S022 |
2020-07-31 |
30-day Notice |
| S021 |
2020-03-09 |
30-day Notice |
| S020 |
2020-02-21 |
30-day Notice |
| S019 | | |
| S018 |
2019-02-01 |
30-day Notice |
| S017 |
2018-07-27 |
Real-time Process |
| S016 |
2017-09-29 |
Normal 180 Day Track |
| S015 |
2015-05-07 |
Normal 180 Day Track |
| S014 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S013 |
2010-08-06 |
30-day Notice |
| S012 |
2009-04-10 |
Normal 180 Day Track No User Fee |
| S011 |
2009-02-06 |
30-day Notice |
| S010 |
2009-03-06 |
Real-time Process |
| S009 |
2006-05-17 |
Normal 180 Day Track No User Fee |
| S008 |
2005-07-22 |
Real-time Process |
| S007 |
2003-07-16 |
Real-time Process |
| S006 |
2003-04-21 |
Real-time Process |
| S005 |
2002-03-28 |
Normal 180 Day Track |
| S004 |
2002-03-06 |
Normal 180 Day Track |
| S003 |
2001-09-20 |
Normal 180 Day Track |
| S002 |
2001-09-20 |
Normal 180 Day Track |
| S001 |
2001-03-27 |
Normal 180 Day Track |
NIH GUDID Devices