P2psa
Device Code: 3139
Product Code(s):
OYA Definition: Quantitative Determination Of [-2]proPSA Antigen In Human Serum To Be Used In Combination With Total PSA And Free PSA To Calculate The Prostate Health Index (phi)
Device Classification Information
| Device Type ID | 3139 |
| Device Name | P2psa |
| Physical State | Reagent Packs, Calibrators, Controls, Substrate And Wash Buffer |
| Technical Method | A Two-site Immunoenzymatic Assay Using Paramagnetic Particles Coated With A Mouse Monoclonal Anti-[-2]proPSA Antibody To Capture The [-2]proPSA And Mouse Monoclonal Anti-PSA Alkaline Phosphatase Conjugate That Reacts With A Chemiluminescent Substrate |
| Target Area | Peripheral Blood |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | OYA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 3139 |
| Device | P2psa |
| Product Code | OYA |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 20:24:28