ONX · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 866.6050
Classification
FDA Product Code
ONX
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.6050
Review panel
IM
Medical specialty
Obstetrics/Gynecology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.