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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceSangia Total PSA Test
Generic NameTotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
ApplicantOpko Diagnostics, LLC
4 Constitution Way
Suite F
Woburn, MA 01801
PMA NumberP170037
Date Received11/07/2017
Decision Date01/30/2019
Withdrawal Date01/23/2024
Product Code MTF 
Docket Number 19M-0505
Notice Date 01/31/2019
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order 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 prostate cancer.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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