PMA
P190022: 4Kscore Test
FDA PMA · Multi-analyte test system with algorithmic analysis for detection of prostate cancer · Opko Health, Inc.
Key facts
| 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. |
| Owner/operator | OPKO Health, Inc. |
| Product code | QRF |
| Approval date | Dec 7, 2021 |
| Docket number | 21M-1271 |
| Notice date | Dec 15, 2021 |
| Establishment registration | 3003652672 |
| FEI number | 3003652672 |
At a glance
- 1–9 Supplements
- Jul 25, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: