4Kscore Test
FDA premarket approval P190022 · decided 2021-12-07
Approval details
- PMA number
- P190022
- Trade name
- 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
- Days to decision
- 823 days
- Decision code
- APPR
- Product code
- QRF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Miami, FL
- 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 patients 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 bio
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SPECTRAL OCT/SLO (K080460) | Opko Health, Inc. | 2008-11-14 |