| Device |
p2psa |
| 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). |
| 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 to generate light. Light production is measured with a luminometer. |
| Target Area |
peripheral blood |
| Review Panel |
Immunology |
|---|
| Product Code | OYA |
|---|
| Submission Type |
PMA
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
|
|
