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 the access hybritech psa on the access 2 immunoassay analyzer. The device is indicated for: the access hybritech psa assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (psa) in human serum using the access immunoassy systems. The device is indicated for the measurement of serum psa in conjunction with digital rectal examination (dre) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for diagnosis of cancer. The device is further indicated for the serial measurement of psa to aid in the prognosis and management of patients with prostate cancer.
| Device | ACCESS HYBRITECH PSA ON THE ACCESS 2 IMMUNOASSAY ANALYZER |
| Classification Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 2002-08-19 |
| Decision Date | 2002-11-27 |
| PMA | P850048 |
| Supplement | S017 |
| Product Code | LTJ |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |