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.
Manufacturing process change to use psa reference calibrators instead of commercial calibrators to establish a valid calibration curve during the in-process qualification of the coated psa paramagnetic particles.
| Device | ACCESS PSA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER |
| 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 | BECKMAN COULTER, INC. |
| Date Received | 2016-07-28 |
| Decision Date | 2016-08-26 |
| PMA | P850048 |
| Supplement | S042 |
| Product Code | MTF |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BECKMAN COULTER, INC. 250 South Kraemer Blvd M/s w-110 brea, CA 92822 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850048 | Original Filing | |
| S058 | 2022-02-04 | 30-day Notice |
| S057 | ||
| S056 | 2020-09-30 | Real-time Process |
| S055 | 2020-07-22 | Real-time Process |
| S054 | 2020-06-23 | Real-time Process |
| S053 | 2019-12-18 | Real-time Process |
| S052 | 2019-05-13 | Real-time Process |
| S051 | 2019-05-02 | Real-time Process |
| S050 | ||
| S049 | 2018-09-25 | Real-time Process |
| S048 | 2017-09-28 | 30-day Notice |
| S047 | ||
| S046 | 2017-06-09 | 30-day Notice |
| S045 | 2017-03-22 | Real-time Process |
| S044 | 2017-01-17 | 30-day Notice |
| S043 | 2016-10-11 | 30-day Notice |
| S042 | 2016-07-28 | 30-day Notice |
| S041 | 2015-05-07 | Real-time Process |
| S040 | 2014-11-04 | 135 Review Track For 30-day Notice |
| S039 | 2014-08-25 | Real-time Process |
| S038 | 2014-08-25 | 135 Review Track For 30-day Notice |
| S037 | 2013-12-17 | Real-time Process |
| S036 | 2013-09-26 | Special (immediate Track) |
| S035 | 2013-06-13 | Special (immediate Track) |
| S034 | 2013-04-12 | Special (immediate Track) |
| S033 | 2013-03-29 | Real-time Process |
| S032 | 2013-01-23 | Real-time Process |
| S031 | 2013-01-03 | 30-day Notice |
| S030 | ||
| S029 | ||
| S028 | 2012-10-25 | Special (immediate Track) |
| S027 | 2012-03-15 | Special (immediate Track) |
| S026 | 2011-12-23 | Real-time Process |
| S025 | 2011-01-12 | Special (immediate Track) |
| S024 | 2011-01-10 | Special (immediate Track) |
| S023 | 2007-12-19 | Real-time Process |
| S022 | 2007-05-16 | Normal 180 Day Track |
| S021 | 2007-08-21 | Panel Track |
| S020 | 2006-04-10 | Real-time Process |
| S019 | 2002-12-20 | Real-time Process |
| S018 | 2002-10-04 | Real-time Process |
| S017 | 2002-08-19 | Normal 180 Day Track |
| S016 | 1999-10-18 | Normal 180 Day Track |
| S015 | 1999-07-12 | 30-day Notice |
| S014 | 1999-05-19 | Normal 180 Day Track |
| S013 | 1999-04-27 | Normal 180 Day Track |
| S012 | 1995-10-27 | Normal 180 Day Track |
| S011 | 1995-06-14 | Special (immediate Track) |
| S010 | ||
| S009 | 1992-06-29 | Panel Track |
| S008 | 1991-12-16 | Normal 180 Day Track |
| S007 | 1991-07-01 | Normal 180 Day Track |
| S006 | 1990-10-02 | Normal 180 Day Track |
| S005 | 1990-02-07 | Normal 180 Day Track |
| S004 | 1989-03-27 | Normal 180 Day Track |
| S003 | 1989-03-02 | Normal 180 Day Track |
| S002 | 1987-02-24 | Normal 180 Day Track |
| S001 | 1987-02-24 | Normal 180 Day Track |