4Kscore Test
FDA premarket approval P190022/S001 · decided 2024-01-08
Approval details
- PMA number
- P190022
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- 4Kscore Test
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Applicant
- Opko Health, Inc.
- Date received
- 2023-08-24
- Decision date
- 2024-01-08
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- QRF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Miami, FL
- Statement
- Approval to transfer the manufacturing site for the preparation of two (iPSA and hK2) of the four 4Kscore Test reagents from the original site, OPKO Diagnostics, LLC., Woburn, Massachusetts, to a new manufacturing site, BioReference Health, LLC., Elmwood Park, New Jersey (BioReference).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SPECTRAL OCT/SLO (K080460) | Opko Health, Inc. | 2008-11-14 |