Approval for the following changes:1) detection technology from spectrophotometry to chemiluminesence2) appropriate reagent process changes to accommodate chemiluminesence detection3) usage on the dimension vista 1500 system4) usage on the dimension vista 3000t system which consists of two dimension vista1500 systems connected by a sample track transport mechanism5) usage on the dimension vista 1500 system connected to the streamlab analyticalworkcell laboratory automation system6) the new dimension vista psa calibrator for use with the dimension vista tpsa and fpsa methods. The device, as modified, will be marketed under the trade name dimension vista tpsa flexreagent cartridge and is indicated for the following uses:the tpsa method is an in vitro diagnostic test for the quantitative measurement of total prostatespecific antigen (psa) in human serum and plasma on the dimension vista system: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) as an aid in themanagement (monitoring) of prostate cancer patients. The dimension vista psa calibrator will be marketed separately for use with the dimensionvista tpsa flex reagent and is indicated for the calibration of total (tpsa) and free (fpsa) prostate specific antigen methods on the dimension vista systems.
| Device | DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE |
| 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 | 2008-12-02 |
| Decision Date | 2010-05-19 |
| PMA | P000021 |
| Supplement | S013 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS 500 Gbc Drive po Box 6101 newark, DE 19714-6101 |
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