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 modification of the abbott architect free psa reagents to be used with the imx free psa and is indicated for: the imx free psa assay is a microparticle enzyme immunoassay (meia) for the quantitative measurement of free prostate specific antigen (psa) in human serum. The imx free psa assay is intended to be used in conjunction with the imx total psa assay in men aged 50 years or older with total psa values between 4 and 10 ng/ml and non-suspicious dre to determine the % free psa value. The imx % free psa value can be used as an aid in discriminating between prostate cancer and benign disease.
| Device | ABBOTT IMX FREE PSA |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | Abbott Laboratories |
| Date Received | 2003-01-31 |
| Decision Date | 2004-02-05 |
| PMA | P980007 |
| Supplement | S003 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| 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 |