Cleared Traditional

ARCHITECT ROMA

K151502 · Fujirebio Diagnostics,Inc. · Immunology
Apr 2016
Decision
329d
Days
Class 2
Risk

About This 510(k) Submission

K151502 is an FDA 510(k) clearance for the ARCHITECT ROMA, 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 April 28, 2016, 329 days after receiving the submission on June 4, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6050.

Submission Details

510(k) Number K151502 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2015
Decision Date April 28, 2016
Days to Decision 329 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.