Approval of the acs:180 and the centaur complexed psa (cpsa) assays on the advia centaur cp system. The device, as modified, will be marketed under the trade name advia centaur cp cpsa and is indicated: the in vitro diagnostic assay is intended to quantitatively measure complexed prostate-specific antigen (cpsa) in human serum using the advia centaur system. The assay 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. The assay is further indicated as an aid in the management (monitoring) of prostate cancer patients.
| Device | BAYER ADVIA IMS COMPLEXED PSA ASSAY |
| Classification Name | Antigen(complexed),prostate Specific,(cpsa) |
| Generic Name | Antigen(complexed),prostate Specific,(cpsa) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2005-07-22 |
| Decision Date | 2005-10-07 |
| PMA | P990055 |
| Supplement | S008 |
| Product Code | NAF |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 333 Coney Street walpole, MA 02032-1516 |
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