Cleared Traditional

ROMA (HE4 EIA + ARCHITECT CA 125 II)

K103358 · Fujirebio Diagnostics,Inc. · Immunology
Sep 2011
Decision
289d
Days
Class 2
Risk

About This 510(k) Submission

K103358 is an FDA 510(k) clearance for the ROMA (HE4 EIA + ARCHITECT CA 125 II), a Ovarian Adnexal Mass Assessment Score Test System (Class II — Special Controls, product code ONX), submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on September 1, 2011, 289 days after receiving the submission on November 16, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6050.

Submission Details

510(k) Number K103358 FDA.gov
FDA Decision Cleared SESU
Date Received November 16, 2010
Decision Date September 01, 2011
Days to Decision 289 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.