FDA-Device2023-12-20Class II
The 4Kscore Test, 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).
BioReference Health, LLC
Hazard
Mathematical modeling of the 4Kscore with and without DRE information was recently performed on over 3,000 specimens. DRE information is a required component of The 4Kscore Test.
Sold states
US Nationwide distribution.
Affected count
1 system (3,196 tests)
Manufactured in
481 Edward H Ross Dr, N/A, Elmwood Park, NJ, United States
Products
The 4Kscore Test, 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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0516-2024Don't want to check this manually?
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