Approval for the acs:180 and advia centaur immunoassay analyzers. The device, as modified, will be marketed under the trade names acs:180 psa immunoassay and advia centaur psa immunoassay and is indicated for the following: the bayer acs:180(tm) and advia centaur(tm) psa assays are in vitro devices intended foro the quantitative measurement of prostate-specific antigen (psa) in human serum. These devices are indicated for the measurement of serum psa in conjunction with digital rectal exam (dre) as an aid in the detection prostate cancer in men aged 50 years and older. Prostate biopsy is required for the diagnosis of prostate cancer. These devices are further indicated as an aid in the management (monitoring) of prostate cancer patients.
| Device | ACS:180(TM)/ADVIA CENTAUR(TM) PSA ASSAY |
| Classification Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2000-07-31 |
| Decision Date | 2000-12-22 |
| Notice Date | 2001-02-07 |
| PMA | P950021 |
| Supplement | S002 |
| Product Code | LTJ |
| Docket Number | 01M-0038 |
| Advisory Committee | Immunology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |
|---|
| P950021 | | Original Filing |
| S025 |
2022-03-22 |
30-day Notice |
| S024 |
2021-04-01 |
30-day Notice |
| S023 |
2020-09-29 |
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 |
2019-07-03 |
Special (immediate Track) |
| S017 |
2019-02-01 |
30-day Notice |
| S016 |
2018-07-27 |
Real-time Process |
| S015 |
2017-08-01 |
Normal 180 Day Track |
| S014 |
2015-05-07 |
Normal 180 Day Track |
| S013 |
2012-03-26 |
Normal 180 Day Track No User Fee |
| S012 |
2010-08-06 |
30-day Notice |
| S011 |
2009-04-10 |
Normal 180 Day Track No User Fee |
| S010 |
2009-02-06 |
30-day Notice |
| S009 |
2009-03-06 |
Real-time Process |
| S008 |
2006-05-17 |
Normal 180 Day Track No User Fee |
| S007 |
2005-07-22 |
Real-time Process |
| S006 |
2003-07-16 |
Real-time Process |
| S005 |
2001-09-20 |
Normal 180 Day Track |
| S004 |
2001-09-20 |
Normal 180 Day Track |
| S003 |
2000-09-28 |
Normal 180 Day Track |
| S002 |
2000-07-31 |
Panel Track |
| S001 |
1998-12-22 |
Panel Track |
NIH GUDID Devices