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Sangia Total PSA Test - P170037

Image of the device.

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Sangia Total PSA Test
PMA Applicant: OPKO Diagnostics, LLC
Address: 4 Constitution Way, Suite F, Woburn, MA 01801
Approval Date: January 30, 2019
Approval Letter: Approval Order

What is it? The Sangia Total Prostate Specific Antigen (PSA) Test consists of a Cassette Assembly and a Sample Collector. The Sangia Total PSA Test is used as an aid in the diagnosis of prostate cancer. This new test is the first point-of-care test that can deliver PSA results near where the patient is being evaluated, for example at the doctor's office, instead of waiting for lab analysis. The test can be administered with a simple finger prick, and results are generated in less than 15 minutes. Prostate-specific antigen, or PSA, is a protein produced by cancerous, as well as noncancerous tissue in the the prostate gland. The PSA test measures the level of PSA in a man's blood.

How does it work? A blood sample from a fingerstick is collected and fills the Sample Collector. The Sample Collector connects to the Cassette Assembly that is then inserted into the Claros 1 Analyzer to complete the test. Each sample run on a Sangia Total PSA Test Cassette includes a separate positive and negative control check that must be passed for the Claros 1 Analyzer to report a total PSA sample result.

When is it used? The Sangia Total PSA Test is used to measure total PSA in the blood from a fingerstick collected by a healthcare professional and is used in addition to a digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years and older in point-of-care settings. A prostate biopsy is required for the diagnosis of prostate cancer.

What will it accomplish? The Sangia Total PSA Test, when used in addition to a DRE, can help in the detection of prostate cancer in men aged 50 years and older. The clinical effectiveness of the Sangia Total PSA Test was demonstrated in a clincal study by testing 434 men at 10 different sites within the U.S. The results showed that the test is safe and effective as an aid in the detection of prostate cancer.

When should it not be used? There are no known reasons for not having the test done.

Additional information (including warnings, precautions, and adverse events):