ONX — Ovarian Adnexal Mass Assessment Score Test System Class II

FDA Device Classification

Classification Details

Product Code
ONX
Device Class
Class II
Regulation Number
866.6050
Submission Type
Review Panel
IM
Medical Specialty
Obstetrics/Gynecology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K153607roche diagnosticsROMA Calculation Tool Using Elecsys AssaysJune 15, 2016
K160090fujirebio diagnosticsLumipulse G ROMAMay 16, 2016
K151502fujirebio diagnosticsARCHITECT ROMAApril 28, 2016
K150588vermillionOVA1 Next GenerationMarch 18, 2016
K103358fujirebio diagnosticsROMA (HE4 EIA + ARCHITECT CA 125 II)September 1, 2011
DEN090004vermillionOVA1 TESTSeptember 11, 2009