Definition: Determines Rate Of Increase Of Total Prostate Specific Antigen At Ultrasensitive Concentration Levels (picogram/ml Serum), And Identifies Those Patients Following Prostatectomies Which Are At Reduced Risk For Recurrence Of Prostate Cancer.
| Device Type ID | 4922 |
| Device Name | Prostate-specific Antigen (psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers |
| Physical State | Capture Antidbody, DNA-labeled Antibody And PCR Reagents. Software |
| Technical Method | Uses Immuno-PCR Technology. Ultrasensitive Levels (picograms/ml Concentration) Of Total Prostate Specific Antigen Are Captured In A Sandwich Immunoassay Using DNA-labeled Antibody. The Sandwich Is Detected By Polymerase Chain Reaction Exponential Amp |
| Target Area | Serum |
| Regulation Description | Gene Expression Profiling Test System For Breast Cancer Prognosis. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Pathology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
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| Submission Type | 510(k) |
| CFR Regulation Number | 866.6040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OWM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |