Approval for the introduction of the immulite 2500 psa and immuite 2500 third generation psa tests for use on the immulite 2500 automated immunoassay analyzer. The devices, as modified, will be marketed under the trade name immulite 2500 psa and immulite 2500 third generation psa assays for the following indication: "the immulite 2500 psa and immuite 2500 third generation psa assays are for in vitro diagnostic use with the immulite 2500 analyzer for the quantitative measurement of prostate-specific antigen (psa) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (dre) in men aged 50 years or older. Each assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients. "
| Device | IMMULITE 2500 PSA, IMMULITE 2500 THIRD GENERATION PSA |
| 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 INC. |
| Date Received | 2003-11-28 |
| Decision Date | 2003-12-31 |
| PMA | P930027 |
| Supplement | S006 |
| Product Code | LTJ |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS HEALTHCARE DIAGNOSTICS INC. glyn Rhonwy, Llanberis gwynedd Ll55 4el LL554 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P930027 | | Original Filing |
| S028 |
2022-09-15 |
30-day Notice |
| S027 | | |
| S026 |
2022-02-28 |
30-day Notice |
| S025 |
2021-04-14 |
30-day Notice |
| S024 |
2020-08-12 |
30-day Notice |
| S023 |
2020-07-23 |
30-day Notice |
| S022 |
2019-11-25 |
30-day Notice |
| S021 |
2019-06-19 |
Special (immediate Track) |
| S020 |
2018-09-28 |
Real-time Process |
| S019 |
2018-03-19 |
Special (immediate Track) |
| S018 |
2017-09-15 |
Special (immediate Track) |
| S017 |
2016-08-17 |
135 Review Track For 30-day Notice |
| S016 |
2014-07-23 |
135 Review Track For 30-day Notice |
| S015 |
2012-05-30 |
135 Review Track For 30-day Notice |
| S014 |
2011-12-19 |
135 Review Track For 30-day Notice |
| S013 |
2011-08-16 |
30-day Notice |
| S012 |
2011-08-08 |
30-day Notice |
| S011 |
2011-02-18 |
Real-time Process |
| S010 |
2009-11-02 |
Normal 180 Day Track No User Fee |
| S009 | | |
| S008 |
2008-12-16 |
Normal 180 Day Track |
| S007 |
2008-11-10 |
Normal 180 Day Track No User Fee |
| S006 |
2003-11-28 |
Real-time Process |
| S005 |
2003-01-21 |
Real-time Process |
| S004 |
2001-01-02 |
Panel Track |
| S003 |
1998-02-20 |
Normal 180 Day Track |
| S002 | | |
| S001 |
1995-10-18 |
Normal 180 Day Track |
NIH GUDID Devices