OWMClass II

Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers

21 CFR 866.6040 / Immunology

OWM is the FDA product code for Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers, a class II device type, regulated under 21 CFR 866.6040. FDA's definition for this code reads: "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". As of 2026-09-10, FDA records hold one 510(k) clearance under this code, the most recent dated 2011-09-20, and no recalls.

Classification record

Product code: OWM
Device name: Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
FDA 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.
Regulation: 21 CFR 866.6040
Device class: Class II
Review panel: Immunology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 1
Ingested recalls: 0

Clearances, product code OWM

By decision year

1 clearance under product code OWM with a decision year between 2011 and 2011, 2011 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code OWM by decision year
Year	Clearances
2011	1

Applicants with the most clearances

Product code OWM

Applicants holding the most 510(k) clearances under product code OWM
Applicant	Clearances
Iris Molecular Diagnostics	1

Companies listing this code with FDA

Companies whose registered establishments list this code

ACRO BIOTECH Inc.

Recent clearances

Product code OWM

K101185Class IINucleic Acid Detection Immunoassay (Nadia) Psa AssayIris Molecular Diagnostics / cleared 2011-09-20

Recent recalls

Product code OWM

FDA records show no recalls under product code OWM.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)