PMA supplement
P190022 S002: The 4Kscore Test
FDA PMA supplement · Real-Time Process · Opko Health, Inc.
Key facts
| Original PMA | P190022 |
|---|---|
| Supplement number | S002 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | The 4Kscore Test |
| Generic name | Multi-analyte test system with algorithmic analysis for detection of prostate cancer |
| Applicant | Opko Health, Inc. |
| Product code | QRF |
| Received date | Nov 1, 2023 |
| Decision date | Jan 30, 2024 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: