This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for addition of the architect free psa to the i2000sr platform, a member of the architect i2000 instrument family. The device, as modified, will be marketed under the trade name architect free psa and is indicated for the quantitative determination of free prostate specific antigen (psa) in human serum. The architect free psa is intended to be used in conjunction with the architect total psa assay in men aged 50 years or older with total psa values between 4 and 10 ng/ml and dre non-suspicious for cancer to determine the % free psa value. The architect % free psa value can be used as an aid in discriminating between prostate cancer and benign disease.
| Device | ABBOTT ARCHITECT FREE PSA |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | Abbott Laboratories |
| Date Received | 2004-04-01 |
| Decision Date | 2004-05-07 |
| PMA | P980007 |
| Supplement | S004 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Laboratories 100 Abbott Park Rd. ap5n-2 Dept 09vb abbott Park, IL 60064-6070 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P980007 | Original Filing | |
| S048 | 2023-01-06 | 30-day Notice |
| S047 | 2022-09-14 | 30-day Notice |
| S046 | 2021-11-18 | 30-day Notice |
| S045 | 2021-11-09 | 30-day Notice |
| S044 | 2021-02-09 | Real-time Process |
| S043 | 2020-10-16 | 30-day Notice |
| S042 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S041 | ||
| S040 | 2015-07-16 | 30-day Notice |
| S039 | 2015-02-24 | 30-day Notice |
| S038 | 2014-11-14 | 30-day Notice |
| S037 | 2014-11-13 | 30-day Notice |
| S036 | 2014-06-02 | 30-day Notice |
| S035 | 2014-04-18 | 30-day Notice |
| S034 | 2014-04-16 | 30-day Notice |
| S033 | 2014-01-08 | 30-day Notice |
| S032 | 2013-10-30 | 30-day Notice |
| S031 | 2013-10-28 | 30-day Notice |
| S030 | 2013-02-11 | 30-day Notice |
| S029 | 2012-11-19 | 30-day Notice |
| S028 | 2012-11-15 | 30-day Notice |
| S027 | 2012-11-13 | 30-day Notice |
| S026 | 2012-07-03 | 30-day Notice |
| S025 | 2012-03-06 | 30-day Notice |
| S024 | 2011-11-23 | Special (immediate Track) |
| S023 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S022 | 2011-09-07 | Special (immediate Track) |
| S021 | 2011-05-25 | 30-day Notice |
| S020 | 2011-05-04 | Normal 180 Day Track No User Fee |
| S019 | 2011-04-18 | 30-day Notice |
| S018 | 2011-02-18 | 30-day Notice |
| S017 | 2011-02-17 | Normal 180 Day Track No User Fee |
| S016 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S015 | 2010-12-22 | Special (immediate Track) |
| S014 | ||
| S013 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S012 | 2010-09-27 | 30-day Notice |
| S011 | 2010-08-09 | Normal 180 Day Track No User Fee |
| S010 | 2010-04-02 | Real-time Process |
| S009 | 2008-05-21 | Normal 180 Day Track |
| S008 | 2007-01-17 | 30-day Notice |
| S007 | ||
| S006 | 2004-08-30 | 30-day Notice |
| S005 | 2004-08-05 | Real-time Process |
| S004 | 2004-04-01 | Real-time Process |
| S003 | 2003-01-31 | Normal 180 Day Track |
| S002 | 2002-02-01 | Normal 180 Day Track |
| S001 | 2001-06-15 | Normal 180 Day Track |