Approval for the vidas tpsa assay indicated as follows: vidas tpsa is intended for use with a vidas (vitek immunodiagnostic assay system) instrument as an automated enzyme-linked fluorescent immunoassay (elfa) for the quantitative measurement of total prostate specific antigen in human serum. The vidas tpsa assay is indicated as an aid in the management of patients with prostate cancer and as an aid in the detection of prostate cancer in conjunction with digital rectal examination (dre) in men age 50 years or older. Prostate biopsy is required for diagnosis of prostate cancer.
| Device | VIDAS TPSA ASSAY |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | BioMerieux, Inc. |
| Date Received | 2004-02-17 |
| Decision Date | 2004-07-08 |
| Notice Date | 2004-08-04 |
| PMA | P040008 |
| Supplement | S |
| Product Code | MTF |
| Docket Number | 04M-0342 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040008 | | Original Filing |
| S013 |
2016-05-03 |
30-day Notice |
| S012 |
2015-07-06 |
30-day Notice |
| S011 |
2015-03-18 |
30-day Notice |
| S010 | | |
| S009 | | |
| S008 |
2014-02-03 |
30-day Notice |
| S007 |
2013-08-15 |
30-day Notice |
| S006 |
2013-02-12 |
30-day Notice |
| S005 |
2013-02-06 |
30-day Notice |
| S004 |
2012-12-18 |
30-day Notice |
| S003 |
2012-10-11 |
Real-time Process |
| S002 |
2012-01-09 |
30-day Notice |
| S001 |
2008-09-04 |
30-day Notice |
NIH GUDID Devices