Approval to add a microtiter plate capture system to the current device. The device, as modified, will be marketed under the trade name oncogene science total psa microtiter elisa and is indicated for the following: the oncogene science total psa microtiter elisa is an in vitro diagnostic assay intended to quantitatively measure total psa in human serum. The assay detects psa both as a free molecule, and when complexed by other molecules, principally alpha-1-antichymotrypsin (act). This device is indicated for the measurement of serum 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. The oncogene science total psa microtiter elisa is further indicated for follow-up and monitoring of patients with prostate cancer. Psa levels measured by this device should be used in conjunction with information available from clinical and other diagnostic procedures in the management of prostate cancer patients.
| Device | TOTAL PSA MICROTITER ELISA |
| 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 | 2001-09-20 |
| Decision Date | 2002-03-19 |
| PMA | P950021 |
| Supplement | S004 |
| Product Code | LTJ |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day 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 |
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