DeviceClearance

Product code ONX— Obstetrics/Gynecology

ARCHITECT ROMA

Classification name
Ovarian Adnexal Mass Assessment Score Test System
Device class
Class 2
Regulation
21 CFR 866.6050
Advisory panel
Obstetrics/Gynecology
Total cleared
6
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code ONX under 21 CFR 866.6050, via openFDA

Market context for product code ONX

FDA has cleared 6 devices under product code ONX between 2009 and 2016, filed by 4 applicant companies. 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.

Clearances per year

Top applicants under product code ONX

Recent clearances under product code ONX

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