Product code
OWM: Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers
FDA product code · Class II · Pathology
Key facts
| Product code | OWM |
|---|---|
| Device | Prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers |
| Device class | Class II |
| Regulation number | 866.6040 |
| Review panel | Pathology |
| Medical specialty | Immunology |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| 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. |
At a glance
- 1–9 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database