IsoPSA Assay
FDA premarket approval P200048 · decided 2025-11-28
Approval details
- 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.
- Date received
- 2020-12-28
- Decision date
- 2025-11-28
- Days to decision
- 1796 days
- Decision code
- APPR
- Product code
- QRF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Cleveland, OH
- 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
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