Sangia Total PSA Test
FDA premarket approval P170037 · decided 2019-01-30
Approval details
- PMA number
- P170037
- Trade name
- Sangia Total PSA Test
- 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
- Days to decision
- 449 days
- Decision code
- APWD
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Woburn, MA
- Statement
- 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 pros
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