Approval for the tandem(r)-r free psa assay and tandem(r)-mp free psa assay. The tandem(r)-r free psa immunoradiometric assay is an in vitro device for the quantitative measurement of free prostate specific antigen (free psa) in human serum. The tandem(r)-mp free psa immunoenzymetric assay is an in vitro device for the quantitative measurement of free prostate specific antigen (free psa) in human serum. Hybritech's tandem free psa assays are intened to beused with tandem (total) psa to calculate the ration of fee psa to total psa expressed as a percentage (percent free psa). Percent free psa as measured by hybritech's tandem assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic condtions, when used in conjuction with tandem (total) psa for prostate cancer detection in men aged 50 years and older with total psa between 4 and 10 ng/ml and digital rectal examination finding that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
| Device | TANDEM-R FREE PSA IMMUNORADIOMETRIC ASSAY/TANDEM-MP FREE PSA IMMUNOENZYMETRIC ASSAY |
| Classification Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | BECKMAN COULTER, INC. |
| Date Received | 1997-08-29 |
| Decision Date | 1998-03-10 |
| Notice Date | 1998-04-16 |
| PMA | P970038 |
| Supplement | S |
| Product Code | MTG |
| Docket Number | 98M-0201 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BECKMAN COULTER, INC. 250 South Kraemer Blvd M/s w-110 brea, CA 92822 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970038 | | Original Filing |
| S045 |
2021-04-19 |
Real-time Process |
| S044 |
2020-09-30 |
Real-time Process |
| S043 |
2020-07-22 |
Real-time Process |
| S042 |
2020-06-23 |
Real-time Process |
| S041 |
2019-12-18 |
Real-time Process |
| S040 |
2019-05-13 |
Real-time Process |
| S039 |
2019-05-02 |
Real-time Process |
| S038 | | |
| S037 |
2018-09-25 |
Real-time Process |
| S036 |
2017-09-28 |
30-day Notice |
| S035 | | |
| S034 |
2017-06-09 |
30-day Notice |
| S033 |
2017-03-22 |
Real-time Process |
| S032 |
2017-01-17 |
30-day Notice |
| S031 |
2015-05-07 |
Real-time Process |
| S030 |
2015-01-27 |
135 Review Track For 30-day Notice |
| S029 |
2014-11-04 |
135 Review Track For 30-day Notice |
| S028 |
2014-08-25 |
Real-time Process |
| S027 |
2014-08-25 |
135 Review Track For 30-day Notice |
| S026 |
2013-12-17 |
Real-time Process |
| S025 |
2013-09-26 |
Special (immediate Track) |
| S024 |
2013-06-13 |
Special (immediate Track) |
| S023 |
2013-04-12 |
Special (immediate Track) |
| S022 |
2013-03-29 |
Real-time Process |
| S021 |
2013-01-23 |
Real-time Process |
| S020 |
2013-01-03 |
30-day Notice |
| S019 | | |
| S018 | | |
| S017 |
2012-10-25 |
Special (immediate Track) |
| S016 |
2012-03-15 |
Special (immediate Track) |
| S015 |
2011-12-23 |
Real-time Process |
| S014 |
2011-01-12 |
Special (immediate Track) |
| S013 |
2011-01-10 |
Special (immediate Track) |
| S012 |
2008-05-27 |
Normal 180 Day Track |
| S011 |
2007-12-19 |
Real-time Process |
| S010 |
2007-05-14 |
30-day Notice |
| S009 |
2007-05-16 |
Normal 180 Day Track |
| S008 |
2006-04-10 |
Real-time Process |
| S007 |
2002-12-20 |
Real-time Process |
| S006 |
2002-10-07 |
Real-time Process |
| S005 |
2002-08-19 |
Normal 180 Day Track |
| S004 |
1999-08-27 |
Normal 180 Day Track |
| S003 |
1999-05-14 |
Normal 180 Day Track |
| S002 |
1999-04-27 |
Normal 180 Day Track |
| S001 |
1998-07-23 |
Normal 180 Day Track |
NIH GUDID Devices