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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
Device4Kscore Test
Generic NameMulti-analyte test system with algorithmic analysis for detection of prostate cancer
ApplicantOPKO Health, Inc.
4400 Biscayne Boulevard
Miami, FL 33137
PMA NumberP190022
Date Received09/06/2019
Decision Date12/07/2021
Product Code QRF 
Docket Number 21M-1271
Notice Date 12/15/2021
Advisory Committee Immunology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the 4Kscore Test.The 4Kscore Test is an in vitro serum or plasma test that combines the results of four immunoassays (Roche Elecsys total PSA (prostate specific antigen), Roche Elecsys free PSA, intact PSA, and human kallikrein 2) into a single numerical score that also incorporates the following information: a patient’s age, previous biopsy, and digital rectal exam (DRE). The 4Kscore Test is indicated for use with other patient information as an aid in the decision for prostate biopsy in men 45 years of age and older who have an abnormal age-specific total PSA and/or abnormal DRE. The 4Kscore Test is intended to aid in detection of aggressive prostate cancer (Gleason score >= 7/Gleason Grade Group >= 2) for whom a biopsy would be recommended by a urologist, based on current standards of care before consideration of the 4Kscore Test.A 4Kscore < 5.0 is associated with decreased likelihood of a Gleason score >= 7 on biopsy. Prostate biopsy is required for the diagnosis of cancer. The test is not recommended more than once every 6 months.The test is intended for professional use only, and is performed at a single-site BioReference Laboratories, Inc.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 
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