4Kscore Test
FDA premarket approval P190022/S003 · decided 2025-07-25
Approval details
- PMA number
- P190022
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- 4Kscore Test
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Applicant
- Opko Health, Inc.
- Date received
- 2025-01-28
- Decision date
- 2025-07-25
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- QRF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- Approval for the addition of the DRE Unavailable variant as part of the 4KScore Test system
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SPECTRAL OCT/SLO (K080460) | Opko Health, Inc. | 2008-11-14 |