510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ONXClass II

Ovarian Adnexal Mass Assessment Score Test System

21 CFR 866.6050 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

ONX is the FDA product code for Ovarian Adnexal Mass Assessment Score Test System, a class II device type, regulated under 21 CFR 866.6050. FDA's definition for this code reads: "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...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
ONX
Device name
Ovarian Adnexal Mass Assessment Score Test System
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.
Regulation
21 CFR 866.6050
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code ONX

By decision year
6 clearances under product code ONX with a decision year between 2009 and 2016, 2016 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code ONX by decision year
YearClearances
20091
20111
20164

Applicants with the most clearances

Product code ONX
Applicants holding the most 510(k) clearances under product code ONX
ApplicantClearances
Fujirebio Diagnostics, Inc.3
Vermillion2
Roche Diagnostics GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code