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.
| Device | 4Kscore Test |
| Generic Name | Multi-analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer |
| Applicant | OPKO Health, Inc. |
| Date Received | 2019-09-06 |
| Decision Date | 2021-12-07 |
| PMA | P190022 |
| Supplement | S |
| Product Code | QRF |
| Advisory Committee | Immunology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OPKO Health, Inc. 4400 Biscayne Boulevard miami, FL 33137 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P190022 | | Original Filing |
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NIH GUDID Devices