Approval for eliminating the test redundancy by using only the bioradlyphocheck immunoassay plus controls in in-process component testing, post-fill testing and final kit combination testing for the assessment of immulite afp, free psa, and psa/3rd generation psa assay performance.
Device | IMMULITE PSA ASSAY |
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 | 2012-05-30 |
Decision Date | 2012-11-08 |
PMA | P930027 |
Supplement | S015 |
Product Code | MTF |
Advisory Committee | Immunology |
Supplement Type | 135 Review Track For 30-day Notice |
Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
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