Approval for the addition of the assay to the bayer acs:180 and advia centaur analyzers. The device, as modified, will be marketed under the trade names bayer acs:180 or advia centaur complexed psa assay and are indicated as follows: this in vitro device is intended to quantitatively measure complexed prostate-specific antigen (cpsa) in human serum using the bayer diagnostics immuno 1, the acs:180 system, or the advia centaur 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.
| Device | BAYER ACS:180 OR ADVIA CENTAUR COMPLEX PSA ASSAYS |
| Classification Name | Antigen(complexed),prostate Specific,(cpsa) |
| Generic Name | Antigen(complexed),prostate Specific,(cpsa) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2001-03-27 |
| Decision Date | 2001-12-07 |
| PMA | P990055 |
| Supplement | S001 |
| Product Code | NAF |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| 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