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 of the following modifications to the abbott axsym total psa assay: 1) change the functional sensitivity claim to 0. 06 ng/ml 2) addition of flomax to the analytical specificity section of the package insert 3) minor labeling changes to the package insert for the purpose of clarification, updates and conformation to requirements of the european community directives. The axsym total psa assay is a microparticle enzyme immunoassay (meia) for the quantitative measurement of total psa (both free psa and psa complexed to alpha-1-antichymotrypsin) in human serum: 1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (dre) in men 50 years or older. Prostatic biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients.
| Device | ABBOTT AXSYM TOTAL PSA ASSAY |
| Generic Name | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | Abbott Laboratories |
| Date Received | 2004-07-29 |
| Decision Date | 2004-09-27 |
| PMA | P910007 |
| Supplement | S011 |
| Product Code | JJE |
| Advisory Committee | Immunology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Laboratories 100 Abbott Park Rd. abbott Park, IL 60064-3500 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P910007 | Original Filing | |
| S059 | 2023-01-06 | 30-day Notice |
| S058 | 2022-09-14 | 30-day Notice |
| S057 | 2021-11-18 | 30-day Notice |
| S056 | 2021-11-09 | 30-day Notice |
| S055 | 2021-02-09 | Real-time Process |
| S054 | 2020-10-16 | 30-day Notice |
| S053 | 2020-03-16 | Normal 180 Day Track No User Fee |
| S052 | 2019-01-22 | Real-time Process |
| S051 | ||
| S050 | 2017-03-01 | 30-day Notice |
| S049 | 2015-07-16 | 30-day Notice |
| S048 | 2015-02-24 | 30-day Notice |
| S047 | 2014-11-14 | 30-day Notice |
| S046 | 2014-11-13 | 30-day Notice |
| S045 | 2014-06-02 | 30-day Notice |
| S044 | 2014-05-01 | 30-day Notice |
| S043 | 2014-04-16 | 30-day Notice |
| S042 | 2014-01-08 | 30-day Notice |
| S041 | 2013-10-30 | 30-day Notice |
| S040 | 2013-10-28 | 30-day Notice |
| S039 | 2013-02-11 | 30-day Notice |
| S038 | 2012-11-19 | 30-day Notice |
| S037 | 2012-11-15 | 30-day Notice |
| S036 | 2012-11-13 | 30-day Notice |
| S035 | 2012-08-03 | 30-day Notice |
| S034 | 2012-03-06 | 30-day Notice |
| S033 | 2011-11-23 | Special (immediate Track) |
| S032 | 2011-11-02 | 135 Review Track For 30-day Notice |
| S031 | 2011-09-07 | Special (immediate Track) |
| S030 | 2011-05-25 | 30-day Notice |
| S029 | 2011-05-04 | Normal 180 Day Track No User Fee |
| S028 | 2011-04-18 | 30-day Notice |
| S027 | 2011-02-18 | 30-day Notice |
| S026 | 2011-02-17 | Normal 180 Day Track No User Fee |
| S025 | 2011-01-31 | Normal 180 Day Track No User Fee |
| S024 | 2010-12-22 | Special (immediate Track) |
| S023 | 2010-11-22 | Normal 180 Day Track No User Fee |
| S022 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S021 | 2010-11-01 | Normal 180 Day Track No User Fee |
| S020 | 2010-09-27 | 30-day Notice |
| S019 | 2010-07-26 | Normal 180 Day Track No User Fee |
| S018 | 2010-04-02 | Real-time Process |
| S017 | 2008-05-21 | Normal 180 Day Track |
| S016 | 2007-01-17 | 30-day Notice |
| S015 | 2005-08-12 | Special (immediate Track) |
| S014 | ||
| S013 | 2005-05-05 | Real-time Process |
| S012 | 2004-08-30 | 30-day Notice |
| S011 | 2004-07-29 | Real-time Process |
| S010 | 2004-04-01 | Real-time Process |
| S009 | 2003-01-31 | Normal 180 Day Track |
| S008 | 2002-03-18 | Special (immediate Track) |
| S007 | 2001-12-05 | Normal 180 Day Track |
| S006 | 2001-06-15 | Normal 180 Day Track |
| S005 | 1997-09-25 | Real-time Process |
| S004 | 1994-11-02 | Panel Track |
| S003 | 1994-08-29 | Special (immediate Track) |
| S002 | 1994-04-04 | Normal 180 Day Track |
| S001 | 1992-08-26 | Normal 180 Day Track |