ONX

6 FDA 510(k) clearances · Product code

FDA profile

Official device name

Ovarian Adnexal Mass Assessment Score Test System

Device class

Class II (moderate risk)

Regulation

21 CFR 866.6050

Medical specialty

Obstetrics/Gynecology

Flags

Third-party review eligible

FDA 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.

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free