Approval for the elecsys(r) free psa immunoassay for elecsys 1010 and 2010 immunoassay analyzers. The device is indicated for: the in vitro quantitative determination of free prostate-specific antigen in human serum and plasma. The elecsys free psa immunoassay is indicated for measurement of fpsa in conjunction with the elecsys total psa assay to develop a ratio (% fpsa) of fpsa to tpsa. This ratio is useful when used in conjunction with the elecsys total psa test as an aid in distinguishing prostate cancer from benign prostatic conditiond in men age 50 years or older who have a digital rectoal examination (dre) that is not suspicious for prostate cancer and an elecsys total psa value in the range 4 ng/ml to 10 ng/ml. Prostate biopsy is required for the diagnosis of prostate cancer. The electrochemiluminescene immunoassay "eclia" is intended for use on the roche elecsys 1010 and 2010 immunoassay analyzers.
| Device | ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK |
| Classification Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Generic Name | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | ROCHE DIAGNOSTICS CORP. |
| Date Received | 2000-07-07 |
| Decision Date | 2000-12-12 |
| Notice Date | 2001-01-03 |
| PMA | P000027 |
| Supplement | S |
| Product Code | LTJ |
| Docket Number | 00M-1683 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ROCHE DIAGNOSTICS CORP. 9115 Hague Rd. indianapolis, IN 46250 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P000027 | | Original Filing |
| S036 |
2021-10-18 |
30-day Notice |
| S035 |
2019-11-27 |
Normal 180 Day Track |
| S034 |
2019-01-29 |
Real-time Process |
| S033 |
2018-10-26 |
Normal 180 Day Track No User Fee |
| S032 |
2018-10-01 |
30-day Notice |
| S031 |
2018-04-17 |
Real-time Process |
| S030 |
2018-03-01 |
Real-time Process |
| S029 | | |
| S028 |
2017-10-11 |
Real-time Process |
| S027 |
2017-08-28 |
Normal 180 Day Track |
| S026 |
2017-08-03 |
30-day Notice |
| S025 |
2017-05-24 |
30-day Notice |
| S024 |
2016-10-26 |
30-day Notice |
| S023 |
2016-09-07 |
Normal 180 Day Track No User Fee |
| S022 |
2016-02-18 |
30-day Notice |
| S021 |
2015-10-07 |
30-day Notice |
| S020 |
2014-11-25 |
30-day Notice |
| S019 |
2014-04-04 |
Real-time Process |
| S018 |
2013-04-09 |
Real-time Process |
| S017 |
2012-12-19 |
135 Review Track For 30-day Notice |
| S016 | | |
| S015 |
2012-02-29 |
30-day Notice |
| S014 |
2012-01-31 |
135 Review Track For 30-day Notice |
| S013 |
2011-11-22 |
30-day Notice |
| S012 |
2011-08-01 |
Normal 180 Day Track |
| S011 |
2011-05-03 |
Normal 180 Day Track No User Fee |
| S010 |
2011-04-25 |
30-day Notice |
| S009 |
2011-04-11 |
135 Review Track For 30-day Notice |
| S008 |
2010-05-27 |
30-day Notice |
| S007 |
2008-09-02 |
30-day Notice |
| S006 |
2008-03-28 |
Normal 180 Day Track |
| S005 |
2007-07-23 |
Normal 180 Day Track |
| S004 |
2006-12-22 |
30-day Notice |
| S003 | | |
| S002 |
2002-10-11 |
Normal 180 Day Track |
| S001 |
2001-11-07 |
Normal 180 Day Track |
NIH GUDID Devices