Cleared Traditional

K081092 - MODIFICATION TO MAMMAPRINT (FDA 510(k) Clearance)

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

K081092 · Agendia · Pathology device
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Dec 2009
Decision
603d
Days
Class 2
Risk

K081092 is an FDA 510(k) clearance for the MODIFICATION TO MAMMAPRINT. Classified as Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer (product code NYI), Class II - Special Controls.

Submitted by Agendia (Amsterdam, NL). The FDA issued a Cleared decision on December 11, 2009 after a review of 603 days - an unusually long review period, suggesting complex equivalence evaluation.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Pathology submissions.

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Submission Details

510(k) Number K081092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2008
Decision Date December 11, 2009
Days to Decision 603 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
526d slower than avg
Panel avg: 77d · This submission: 603d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.