# QRF · Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer

_ ·  · Class 3_

**Canonical URL:** https://fda.innolitics.com/productcode/QRF

## Overview

- **Product Code:** QRF
- **Device Name:** Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## 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](/device/P200048.md) | IsoPSA Assay | Cleveland Diagnostics, Inc. | Nov 28, 2025 | APPR |
| [P190022](/device/P190022.md) | 4Kscore Test | Opko Health, Inc. | Dec 7, 2021 | APPR |

## Top Applicants

- Cleveland Diagnostics, Inc. — 1 clearance
- Opko Health, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/productcode/QRF](https://fda.innolitics.com/productcode/QRF)

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