ONX · Ovarian Adnexal Mass Assessment Score Test System

Obstetrics/Gynecology · 21 CFR 866.6050 · Class 2

Overview

Identification

An ovarian/adnexal mass assessment test system is a device that measures one or more proteins in serum or plasma. 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 is for adjunctive use, in the context of a negative primary clinical and radiological evaluation, to augment the identification of patients whose gynecologic surgery requires oncology expertise and resources.

Classification Rationale

Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” For the availability of this guidance document, see § 866.1(e).

Special Controls

The device is classified as Class II under regulation 21 CFR 866.6050 with special controls. The special control guidance document, "Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System" accompanies this device.

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System.” For the availability of this guidance document,*see* § 866.1(e).(c) *Black box warning.* Under section 520(e) of the Federal Food, Drug, and Cosmetic Act these devices are subject to the following restriction: A warning statement must be placed in a black box and must appear in all advertising, labeling, and promotional material for these devices. That warning statement must read:

Recent Cleared Devices (6 of 6)

Top Applicants

• Fujirebio Diagnostics,Inc. — 3 clearances
• Roche Diagnostics — 1 clearance
• Vermillion — 1 clearance
• Vermillion, Inc. — 1 clearance