OWM

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

Product code

OWM

Device name

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

Device class

Class 2

21 CFR

21 CFR 866.6040

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).