Approval for the addition of the advia centaur xp instrument (with version 5. 0software) to the instrument(s) using the advia centaur cpsa assay. The device, as modified, will be marketed under the trade name advia centaur and advia centaur xp cpsa assay and isindicated 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 and older. Prostate biopsy is required for the diagnosis of prostate cancer. This assay is further indicated as an aid in the management (monitoring) of patients with prostate cancer.
| Device | ADVIA CENTAUR XP CPSA ASSAY ON THE ADVIA CENTAUR XP (WITH VERSION 5.0 SOFTWARE) |
| Classification Name | Antigen(complexed),prostate Specific,(cpsa) |
| Generic Name | Antigen(complexed),prostate Specific,(cpsa) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2009-04-10 |
| Decision Date | 2009-06-10 |
| PMA | P990055 |
| Supplement | S012 |
| Product Code | NAF |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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 |
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