Approval for the dimension fpsa flex reagent cartridge and dimension t/f psa calibrator for dimension rxl and xpand systems. The dimension fpsa flex reagent cartridge is indicated for: the fpsa method for the dimension clinical chemistry system with the heterogenous immunoassay module is an in vitro diagnostic test intended to quantitatively measure free prostate specific antigen (fpsa) in human serum. Measurement of fpsa are used in conjunction with total psa (tpsa) method on dimension system to calculate fpsa to tpsa ratio expressed as a percent fpsa. The percent fpsa is used as an aid in distinguishing prostate cancer from benign prostate conditions in men 50 years or older with tpsa of 4. 0 to 10. 0 ng/ml [ug/l] and digital rectal examination (dre) findings not suspicious for cancer. Prostate biopsy is required for diagnosis of cancer. The dimension t/f psa calibrator is indicated for: the t/f psa calibrator is an in vitro diagnostic product intended to be used to calibrate the total (tpsa) and free (fpsa) prostate specific antigen methods for the dimension clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of these methods.
| Device | DIMENSION FPSA FLEX REAGENT CARTRIDGE AND DIMENSION T/F PSA CALIBRATOR FOR DIMENSION RXL AND XPAND SYSTEMS |
| Classification Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS |
| Date Received | 2002-07-05 |
| Decision Date | 2003-01-24 |
| Notice Date | 2003-02-05 |
| PMA | P020027 |
| Supplement | S |
| Product Code | MTG |
| Docket Number | 03M-0046 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 500 Gbc Drive, P O Box 6101 m/s 514 newark, DE 19714-6101 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020027 | | Original Filing |
| S039 |
2021-11-18 |
30-day Notice |
| S038 |
2020-09-14 |
30-day Notice |
| S037 | | |
| S036 |
2019-06-19 |
30-day Notice |
| S035 |
2019-05-13 |
30-day Notice |
| S034 |
2018-09-28 |
Real-time Process |
| S033 |
2018-06-18 |
30-day Notice |
| S032 |
2018-04-17 |
30-day Notice |
| S031 | | |
| S030 |
2017-11-20 |
30-day Notice |
| S029 |
2017-10-16 |
30-day Notice |
| S028 |
2017-09-25 |
Normal 180 Day Track No User Fee |
| S027 |
2017-06-20 |
30-day Notice |
| S026 |
2017-04-26 |
30-day Notice |
| S025 |
2017-02-17 |
30-day Notice |
| S024 |
2016-08-03 |
30-day Notice |
| S023 |
2015-12-07 |
Normal 180 Day Track |
| S022 |
2015-06-04 |
135 Review Track For 30-day Notice |
| S021 |
2014-08-27 |
30-day Notice |
| S020 |
2013-05-03 |
30-day Notice |
| S019 |
2012-10-31 |
30-day Notice |
| S018 |
2012-03-08 |
30-day Notice |
| S017 |
2012-02-01 |
Real-time Process |
| S016 |
2011-11-22 |
30-day Notice |
| S015 |
2011-06-30 |
Normal 180 Day Track |
| S014 |
2010-10-18 |
Real-time Process |
| S013 |
2010-08-19 |
Normal 180 Day Track |
| S012 |
2010-07-06 |
Real-time Process |
| S011 |
2010-03-25 |
30-day Notice |
| S010 |
2009-05-26 |
Normal 180 Day Track |
| S009 |
2008-12-02 |
Normal 180 Day Track |
| S008 |
2008-03-03 |
Special (immediate Track) |
| S007 |
2008-02-26 |
30-day Notice |
| S006 |
2007-08-14 |
Real-time Process |
| S005 |
2006-12-06 |
30-day Notice |
| S004 |
2005-06-29 |
30-day Notice |
| S003 |
2005-04-01 |
Special (immediate Track) |
| S002 |
2005-01-31 |
30-day Notice |
| S001 |
2003-09-29 |
Real-time Process |
NIH GUDID Devices