ONX

Ovarian Adnexal Mass Assessment Score Test System

Product code

ONX

Device name

Ovarian Adnexal Mass Assessment Score Test System

Device class

Class 2

21 CFR

21 CFR 866.6050

Medical specialty

Obstetrics/Gynecology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

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

FDA classification definition

An ovarian/adnexal mass assessment test is a devicem that measures one or more proteins in serum. It yields a single result for the likelihood that an adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. The test isn for adjunctive use, in teh context of a negative primary clinical and radiological evaluation, to augmrent the identification of patienets whose gynecologic surgery requires oncology expertise and resources.

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