Cleared Traditional

K151502 - ARCHITECT ROMA

K151502 is an FDA 510(k) clearance for ARCHITECT ROMA, manufactured by Fujirebio Diagnostics,Inc.. The device is a Class 2 Immunology device with product code ONX cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K151502 · Fujirebio Diagnostics,Inc. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
329d
Days
Class 2
Risk

K151502 is an FDA 510(k) clearance for the ARCHITECT ROMA. 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 April 28, 2016 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K151502

510(k) Number K151502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 105d · This submission: 329d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ONX Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ONX Ovarian Adnexal Mass Assessment Score Test System

Devices cleared under the same product code (ONX) and FDA review panel - the closest regulatory comparables to K151502.
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K160090 · Fujirebio Diagnostics,Inc. · May 2016
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ROMA (HE4 EIA + ARCHITECT CA 125 II)
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OVA1 TEST
DEN090004 · Vermillion · Sep 2009
K151502 · ARCHITECT ROMA
Download PDF FDA Summary Fujirebio Diagnostics…