Approval of the immuno 1 prostate specific antigen (psa) on the advia integrated modular system (ims). The device, as modified, will be marketed under the trade name advia ims prostate specific antigen (psa) and is indicated for: the advia ims prostate specific antigen (psa) method is for in vitro diagnostic use to quantitatively measure prostate specific antigen (psa) in human serum. This assay is indicated for the measurement of the serum psa in conjunction with digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 year and older. This assay 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 ADVIA IMS PSA ASSAY |
| Classification Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2003-07-16 |
| Decision Date | 2003-09-02 |
| PMA | P950021 |
| Supplement | S006 |
| Product Code | MTF |
| 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 |
|---|
| 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