| Device |
prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers |
| Regulation Description |
Gene expression profiling test system for breast cancer prognosis. |
| 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. |
| 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 amplification. Rate of increase in PSA concentration over a time period is determined by computer software. |
| Target Area |
Serum |
| Regulation Medical Specialty |
Immunology |
| Review Panel |
Pathology |
|---|
| Product Code | OWM |
|---|
| Premarket Review |
Division of Molecular Genetics and Pathology
(DMGP)
Division of Molecular Genetics and Pathology
(DMGP)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
866.6040
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
