Cleared Traditional

OVA1 Next Generation

K150588 · Vermillion, Inc. · Immunology

Mar 2016

Decision

375d

Days

Class 2

Risk

About This 510(k) Submission

K150588 is an FDA 510(k) clearance for the OVA1 Next Generation, a Ovarian Adnexal Mass Assessment Score Test System (Class II — Special Controls, product code ONX), submitted by Vermillion, Inc. (Austin, US). The FDA issued a Cleared decision on March 18, 2016, 375 days after receiving the submission on March 9, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6050.

Submission Details

510(k) Number	K150588 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2015
Decision Date	March 18, 2016
Days to Decision	375 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	ONX — Ovarian Adnexal Mass Assessment Score Test System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.6050
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.