Device product
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).
Z-0516-2024
Product summary
- Event
- Event 93050
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 system (3,196 tests)
- Official record key
device-enforcement:Z-0516-2024
Official wording
Reason: 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.
Code information: UDI-DI: 00850038860004
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.