FDA product code OWM: Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
OWM is the FDA product code for prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers. It is a Class II device, regulated under 21 CFR 866.6040 and reviewed by the Pathology panel. FDA has cleared 1 510(k) submission under OWM. The average 510(k) review took 510 days (median 510).
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.
Classification
| Field | Value |
|---|---|
| Device name | Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers |
| Device class | Class II |
| Regulation | 21 CFR 866.6040 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every OWM clearance
Top OWM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Iris Molecular Diagnostics | 1 | 2011-09-20 |
Most recent OWM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K101185 | Iris Molecular Diagnostics | NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY | 2011-09-20 | 510 |
Recalls for OWM devices
openFDA lists no recalls for product code OWM.
Frequently asked questions
What is FDA product code OWM?
OWM is the FDA product code for prostate-specific antigen (psa) for prognostic, recurrence risk assessment of prostate cancers. It is a Class II device, regulated under 21 CFR 866.6040 and reviewed by the Pathology panel.
What device class is OWM?
Class II, regulation 21 CFR 866.6040. Typical premarket route: 510(k).
How long does a 510(k) take for product code OWM?
Across 1 cleared submissions the average was 510 days from receipt to decision (median 510).
Which companies have the most OWM clearances?
Iris Molecular Diagnostics (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OWM
- Run a recall and safety report across every OWM manufacturer
- Watch product code OWM for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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