Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
The Prostate-Specific Antigen (PSA) for Prognostic, Recurrence Risk Assessment of Prostate Cancers is an in vitro diagnostic device that determines the rate of increase of total PSA at ultrasensitive concentration levels and identifies patients following prostatectomy who are at reduced risk for recurrence of prostate cancer. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWM, with regulation number 866.6040 under the Immunology medical specialty.
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Basic Information
- Product Code
- OWM
- Device Class
- FDA class 2
- Regulation Number
- 866.6040
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K101185 | NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY | Sep 20, 2011 | Substantially Equivalent | Iris Molecular Diagnostics |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.