Cleared Traditional

ROMA Calculation Tool Using Elecsys Assays

K153607 · Roche Diagnostics · Immunology

Jun 2016

Decision

181d

Days

Class 2

Risk

About This 510(k) Submission

K153607 is an FDA 510(k) clearance for the ROMA Calculation Tool Using Elecsys Assays, a Ovarian Adnexal Mass Assessment Score Test System (Class II — Special Controls, product code ONX), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on June 15, 2016, 181 days after receiving the submission on December 17, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6050.

Submission Details

510(k) Number	K153607 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 17, 2015
Decision Date	June 15, 2016
Days to Decision	181 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.