Cleared Traditional

ROMA (HE4 EIA + ARCHITECT CA 125 II) (K103358) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K103358 is an FDA 510(k) clearance for the ROMA (HE4 EIA + ARCHITECT CA 125 II). Classified as Ovarian Adnexal Mass Assessment Score Test System (product code ONX), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on September 1, 2011 after a review of 289 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.6050 - the FDA immunology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Fujirebio Diagnostics,Inc. devices

Submission Details

510(k) Number K103358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 104d · This submission: 289d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ONX Ovarian Adnexal Mass Assessment Score Test System
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.