Approval for the sangia total psa test. The sangia total psa test is an immunoassay indicated to quantitatively measure total psa in capillary whole blood from a fingerstick collected by a healthcare professional and is used in conjunction with a digital rectal exam (dre) as an aid in the detection of prostate cancer in men aged 50 years and older. The sangia total psa test is performed using the claros 1 analyzer in point-of-care settings. A prostate biopsy is required for the diagnosis of prostate cancer.
| Device | Sangia Total PSA Test |
| Classification Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Generic Name | Total, Prostate Specific Antigen (noncomplexed & Complexed) For Detection Of Prostate Cancer |
| Applicant | OPKO Diagnostics, LLC. |
| Date Received | 2017-11-07 |
| Decision Date | 2019-01-30 |
| Notice Date | 2019-01-31 |
| PMA | P170037 |
| Supplement | S |
| Product Code | MTF |
| Docket Number | 19M-0505 |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OPKO Diagnostics, LLC. 4 Constitution Way suite F woburn, MA 01801 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170037 | Original Filing |