• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
DeviceSangia Total PSA Test
Classification Nametotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Generic Nametotal, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Applicant
OPKO Diagnostics, LLC.
4 constitution way
suite f
woburn, MA 01801
PMA NumberP170037
Date Received11/07/2017
Decision Date01/30/2019
Product Code
MTF[ Registered Establishments with MTF ]
Docket Number 19M-0505
Notice Date 01/31/2019
Advisory Committee Immunology
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
-
-