QRF · Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
· Class 3
Overview
| Product Code | QRF |
|---|---|
| Device Name | Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer |
| Device Class | Class 3 |
| Review Panel |
Identification
Test system that combines values from multiple assays with/without other patient information to yield a score value for aid in detection of prostate cancer and/or decision for prostate biopsy.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P200048 | IsoPSA Assay | Cleveland Diagnostics, Inc. | Nov 28, 2025 | APPR |
| P190022 | 4Kscore Test | Opko Health, Inc. | Dec 7, 2021 | APPR |
Top Applicants
- Cleveland Diagnostics, Inc. — 1 clearance
- Opko Health, Inc. — 1 clearance
