Approval for the dimension(r) rxl psa flex(r) reagent cartridge. The device is indicated for the following: the psa method for the dimension(r) clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure prostate specific antigen (psa) in human serum: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. 2) as an aid in the management (monitoring) of prostate cancer patients.
| Device | DIMENSION(R) RXL PSA FLEX(R) REAGENT CARTRIDGE |
| 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 | 2000-06-05 |
| Decision Date | 2001-07-05 |
| Notice Date | 2001-07-23 |
| PMA | P000021 |
| Supplement | S |
| Product Code | LTJ |
| Docket Number | 01M-0310 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 500 Gbc Drive po Box 6101 newark, DE 19714-6101 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000021 | | Original Filing |
| S044 |
2021-11-18 |
30-day Notice |
| S043 |
2020-09-14 |
30-day Notice |
| S042 | | |
| S041 |
2019-06-19 |
30-day Notice |
| S040 |
2019-05-13 |
30-day Notice |
| S039 |
2018-09-28 |
Real-time Process |
| S038 |
2018-06-18 |
30-day Notice |
| S037 |
2018-04-17 |
30-day Notice |
| S036 | | |
| S035 |
2017-11-20 |
30-day Notice |
| S034 |
2017-10-16 |
30-day Notice |
| S033 |
2017-09-25 |
Normal 180 Day Track No User Fee |
| S032 |
2017-06-20 |
30-day Notice |
| S031 |
2017-04-26 |
30-day Notice |
| S030 |
2017-02-17 |
30-day Notice |
| S029 |
2016-08-03 |
30-day Notice |
| S028 |
2015-12-07 |
Normal 180 Day Track |
| S027 |
2015-06-04 |
135 Review Track For 30-day Notice |
| S026 |
2014-08-27 |
30-day Notice |
| S025 |
2013-05-03 |
30-day Notice |
| S024 |
2012-10-31 |
30-day Notice |
| S023 |
2012-03-20 |
Real-time Process |
| S022 |
2012-03-08 |
30-day Notice |
| S021 |
2011-11-22 |
30-day Notice |
| S020 |
2011-06-30 |
Normal 180 Day Track |
| S019 |
2010-10-18 |
Real-time Process |
| S018 |
2010-08-19 |
Normal 180 Day Track |
| S017 |
2010-07-06 |
Real-time Process |
| S016 |
2010-03-25 |
30-day Notice |
| S015 |
2009-05-19 |
Normal 180 Day Track |
| S014 |
2009-04-06 |
Real-time Process |
| S013 |
2008-12-02 |
Normal 180 Day Track |
| S012 |
2008-03-03 |
Special (immediate Track) |
| S011 |
2008-02-26 |
30-day Notice |
| S010 |
2007-08-14 |
Real-time Process |
| S009 |
2006-12-06 |
30-day Notice |
| S008 |
2005-06-24 |
30-day Notice |
| S007 | | |
| S006 |
2005-04-01 |
Special (immediate Track) |
| S005 |
2005-01-31 |
30-day Notice |
| S004 |
2004-11-15 |
Real-time Process |
| S003 |
2003-12-17 |
Real-time Process |
| S002 |
2002-03-26 |
Normal 180 Day Track |
| S001 |
2001-07-12 |
Real-time Process |
NIH GUDID Devices