Not Cleared Post-NSE

DEN070009 - MAMMAPRINT

DEN070009 is an FDA 510(k) submission for MAMMAPRINT, manufactured by Agendia BV. The device is a Class 2 Pathology device with product code NYI cleared through the Post-NSE 510(k) pathway after a 7-day FDA review.

DEN070009 · Agendia BV · Pathology device
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Feb 2007
Decision
7d
Days
Class 2
Risk

DEN070009 is an FDA 510(k) submission (not cleared) for the MAMMAPRINT. Classified as Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer (product code NYI), Class II - Special Controls.

Submitted by Agendia BV (Amsterdam, NL). The FDA issued a Not Cleared (DENG) decision on February 6, 2007 after a review of 7 days.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 866.6040 - the FDA pathology 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 Pathology review framework.

FDA 510(k) Submission Details - DEN070009

510(k) Number DEN070009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 30, 2007
Decision Date February 06, 2007
Days to Decision 7 days
Submission Type Post-NSE
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 78d · This submission: 7d
Pathway characteristics

NYI Device Classification - Class 2, Special Controls

Product Code NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.6040
Definition A Device Which Uses A Gene Expression Profile Of A Breast Cancer Tumor, From Patients Stage I Or Stage Ii Lymph Node Negative, With A Tumor Size Of <5.0 Cm, To Provide A Risk Assessment For Distant Recurrence Of Breast Cancer. The Result Is Indicated For Use Only As A Prognostic Marker By Physicians Along With A Number Of Other Factors To Assess The Risk Of Recurrence Of Breast Cancer.
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 Pathology devices follow this clearance model.

DEN070009 · MAMMAPRINT
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