Approval of the following modifications to the dimension fpsa flex reagent cartridge: 1) addition of lithium heparin plasma as a sample type in the intended use and the package labeling. 2) addition of the disclaimer "results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings" to the results section of the package labeling. 3) correction of the units for igg in the package labeling from 6 g/ml to 6 g/dl. The device, as modified, will be marketed under the same trade name, dimension fpsa flex reagent cartridge and is indicated as follows: 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 and plasma. Measurements of fpsa are used in conjunction with total psa (tpsa) on the dimension system to calculate fpsa to tpsa ratio expressed as 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 prostate cancer.
| Device | DIMENSION FPSA FLEX REAGENT CARTRIDGE |
| 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 | 2003-09-29 |
| Decision Date | 2003-10-10 |
| PMA | P020027 |
| Supplement | S001 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |
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