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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 NumberS001
Date Received08/24/2023
Decision Date01/08/2024
Product Code QRF 
Advisory Committee Immunology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to transfer the manufacturing site for the preparation of two (iPSA and hK2) of the four 4Kscore Test reagents from the original site, OPKO Diagnostics, LLC., Woburn, Massachusetts, to a new manufacturing site, BioReference Health, LLC., Elmwood Park, New Jersey (BioReference).
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