Cleared Traditional

K141142 - MAMMAPRINT FFPE (FDA 510(k) Clearance)

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

K141142 · Agendia · Pathology device
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Jan 2015
Decision
266d
Days
Class 2
Risk

K141142 is an FDA 510(k) clearance for the MAMMAPRINT FFPE. 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 January 23, 2015 after a review of 266 days - an extended review cycle.

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

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Submission Details

510(k) Number K141142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2014
Decision Date January 23, 2015
Days to Decision 266 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
189d slower than avg
Panel avg: 77d · This submission: 266d
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.