Product code OWM— Immunology

NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY

Classification name: Prostate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers
Device class: Class 2
Regulation: 21 CFR 866.6040
Advisory panel: Immunology
Total cleared: 1
First cleared: 2011-09-20
Most recent: 2011-09-20

FDA classification 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.”
— U.S. Food and Drug Administration, device classification record for product code OWM under 21 CFR 866.6040, via openFDA

Market context for product code OWM

FDA has cleared 1 device under product code OWM, all in 2011, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OWM

Iris Molecular Diagnostics1 clearance

Recent clearances under product code OWM

K101185 — NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAYIris Molecular Diagnostics·2011-09-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.