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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Device4Kscore Test
Generic NameMulti-analyte test system with algorithmic analysis for detection of prostate cancer
ApplicantOpko Health, Inc.
4400 Biscayne Blvd.
Miami, FL 33137
PMA NumberP190022
Supplement NumberS003
Date Received01/28/2025
Decision Date07/25/2025
Product Code QRF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the addition of the DRE Unavailable variant as part of the 4KScore Test system
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