Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
Basic Information
- Device Name
- Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer
- Trade Name
- IsoPSA Assay
- PMA Number
- P200048
- Device Class
- FDA Class 3
- Product Code
- QRF
- Generic Name
- Multi-analyte test system with algorithmic analysis for detection of prostate cancer
- Medical Specialty
- Unknown
- Advisory Committee
- Immunology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 28, 2025
- Date Received
- December 28, 2020
- Expedited Review
- N
- Docket Number
- FDA-7024
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QRF | Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer | FDA class 3 | Unknown |