Approval for an update to the instructions for use (ifu) high-dose hook effect claim on immulite / immulite 1000 and immulite 2000 platforms with values obtained for complex psa (psa-act) high dose effect.
| Device | Immulite/Immulite 1000 PSA/Immulite 2000 PSA |
| 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 INC. |
| Date Received | 2018-03-19 |
| Decision Date | 2018-04-16 |
| PMA | P930027 |
| Supplement | S019 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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