PMA P200048
- Device
- IsoPSA Assay
- Applicant
- Cleveland Diagnostics, Inc.
- PMA number
- P200048
- Product code
- QRF
- Decision date
- 2025-11-28
- Classification
- Immunology
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- 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.
Current openFDA PMA Record#
- Device
- IsoPSA Assay
- Applicant
- Cleveland Diagnostics, Inc.
- PMA number
- P200048
- Product code
- QRF
- Generic name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Decision date
- 2025-11-28
- Decision code
- APPR
- Date received
- 2020-12-28
- 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.