Not Cleared Post-NSE

DEN090004 - OVA1 TEST

DEN090004 is an FDA 510(k) submission for OVA1 TEST, manufactured by Vermillion. The device is a Class 2 Immunology device with product code ONX cleared through the Post-NSE 510(k) pathway after a 51-day FDA review.

DEN090004 · Vermillion · Immunology device
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Sep 2009
Decision
51d
Days
Class 2
Risk

DEN090004 is an FDA 510(k) submission (not cleared) for the OVA1 TEST. Classified as Ovarian Adnexal Mass Assessment Score Test System (product code ONX), Class II - Special Controls.

Submitted by Vermillion (Fremont, US). The FDA issued a Not Cleared (DENG) decision on September 11, 2009 after a review of 51 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Immunology review framework.

FDA 510(k) Submission Details - DEN090004

510(k) Number DEN090004 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 22, 2009
Decision Date September 11, 2009
Days to Decision 51 days
Submission Type Post-NSE
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 105d · This submission: 51d
Pathway characteristics

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.

DEN090004 · OVA1 TEST
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