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| Device | IsoPSA Assay |
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| Generic Name | Multi-analyte test system with algorithmic analysis for detection of prostate cancer |
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| Applicant | Cleveland Diagnostics, Inc.
3615 Superior Ave., Suite 4407b
Cleveland, OH 44114 |
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| PMA Number | P200048 |
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| Date Received | 12/28/2020 |
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| Decision Date | 11/28/2025 |
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| Product Code |
QRF |
| Docket Number | FDA-7024 |
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| Notice Date | 12/12/2025 |
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| Advisory Committee |
Immunology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
Approval for the IsoPSA Assay.The IsoPSA Assay is an in vitro test system that combines the results of total Prostate Specific Antigen (PSA) (Elecsys, Roche Diagnostics) and free PSA (Elecsys, Roche Diagnostics) from partitioned heparinized plasma into a single numerical index. The IsoPSA Assay is indicated for use in conjunction with other patient information to aid in detection of high-grade prostate cancer (Grade Group >= 2; Gleason score >= 7) in men >= 50 years of age, with total PSA levels >= 4.0 to =< 10.0 ng/mL for whom a biopsy is being considered by a urologist based on current standard of care, before consideration of IsoPSA Assay results.Prostatic biopsy is required for the diagnosis of cancer. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling |
Labeling Part 2 |
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| Post-Approval Study | Show Report Schedule and Study Progress |
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