PMA
P200048: IsoPSA Assay
FDA PMA · Multi-analyte test system with algorithmic analysis for detection of prostate cancer · Cleveland Diagnostics, Inc.
Key facts
| PMA number | P200048 |
|---|---|
| Trade name | IsoPSA Assay |
| Generic name | Multi-analyte test system with algorithmic analysis for detection of prostate cancer |
| Applicant | Cleveland Diagnostics, Inc. |
| Owner/operator | Cleveland Diagnostics, Inc. |
| Product code | QRF |
| Approval date | Nov 28, 2025 |
| Docket number | FDA-7024 |
| Notice date | Dec 12, 2025 |
| Establishment registration | 3011015335 |
| FEI number | 3011015335 |
At a glance
- 1–9 Supplements
- Jul 28, 2026 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- No Withdrawn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: