This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the access hybritech p2psa on the access immunoassay systems. This device is indicated for: the access hybritech p2psa assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of [-2]propsa antigen, an isoform of freepsa, in human serum using the access immunoassay systems. Access hybritech p2psa is intended to be used in combination with access hybritech (total) psa and access hybritech free psa to calculate the beckman coulter prostate health index (phi), an in vitro diagnostic multivariate index assay (ivdmia). Beckman coulter phi as calculated using the access hybritech assays is indicated for use asan aid in distinguishing prostate cancer from benign prostatic conditions, for prostate cancer detection in men aged 50 years and older with total psa >= 4. 0 to
| Device | ACCESS HYBRITECH P2PSA ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Classification Name | P2psa |
| Generic Name | P2psa |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 2009-11-17 |
| Decision Date | 2012-06-14 |
| Notice Date | 2012-06-20 |
| PMA | P090026 |
| Supplement | S |
| Product Code | OYA |
| Docket Number | 12M-0638 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BECKMAN COULTER, INC. 1000 Lake Hazeltine Dr. chaska, MN 55318 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P090026 | Original Filing | |
| S031 | 2021-04-19 | Real-time Process |
| S030 | 2020-09-30 | Real-time Process |
| S029 | 2020-07-22 | Real-time Process |
| S028 | 2020-06-23 | Real-time Process |
| S027 | 2019-12-18 | Real-time Process |
| S026 | 2019-05-13 | Real-time Process |
| S025 | 2019-05-02 | Real-time Process |
| S024 | ||
| S023 | 2018-12-17 | 30-day Notice |
| S022 | 2018-09-25 | Real-time Process |
| S021 | 2017-09-28 | 30-day Notice |
| S020 | ||
| S019 | 2017-06-09 | 30-day Notice |
| S018 | 2017-03-22 | Real-time Process |
| S017 | 2017-01-23 | 30-day Notice |
| S016 | 2017-01-17 | 30-day Notice |
| S015 | 2015-05-07 | Real-time Process |
| S014 | 2014-11-04 | 135 Review Track For 30-day Notice |
| S013 | 2014-08-25 | Real-time Process |
| S012 | 2014-08-25 | 135 Review Track For 30-day Notice |
| S011 | 2014-06-12 | 30-day Notice |
| S010 | 2013-12-17 | Real-time Process |
| S009 | 2013-09-26 | Special (immediate Track) |
| S008 | 2013-06-13 | Special (immediate Track) |
| S007 | 2013-04-12 | Special (immediate Track) |
| S006 | 2013-03-29 | Real-time Process |
| S005 | 2013-01-23 | Real-time Process |
| S004 | 2013-01-03 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 | 2012-10-25 | Special (immediate Track) |