Cleared Traditional

K103358 - ROMA (HE4 EIA + ARCHITECT CA 125 II)

K103358 is the FDA 510(k) clearance for ROMA (HE4 EIA + ARCHITECT CA 125 II) by Fujirebio Diagnostics,Inc.. It is a Class 2 Immunology device (product code ONX) cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K103358 · Fujirebio Diagnostics,Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 104d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Immunology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00987649 Completed Observational Industry-sponsored

Ovarian Cancer Risk Estimation in Patients With Pelvic Mass

Evaluation of CA125 and HE4 Assays to Estimate the Risk of Ovarian Cancer in Patients Presenting to a General Surgeon or Obstetrician/Gynecologist With an Adnexal Mass

512
Patients (actual)
13
Sites
Condition studied Adnexal Mass; Ovarian Cancer
Eligibility Female only · 18 Years+
Principal investigator Richard Moore, MD, FACOG, FACS
Sponsor Fujirebio Diagnostics, Inc. (industry)
Started 2009-10-01 → Primary completion 2010-08-01 → Completed 2010-09-01
Primary outcome
1. A statistically higher number of cancer patients are correctly assigned by the combination of Initial Cancer Risk assessment and positive ROMA test result than by Initial Cancer Risk assessment alone
Study completed - no results published. This trial concluded in 2010 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov