Cleared Traditional

K070675 - MAMMAPRINT

K070675 is an FDA 510(k) clearance for MAMMAPRINT, manufactured by Agendia BV. The device is a Class 2 Pathology device with product code NYI cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K070675 · Agendia BV · Pathology device
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Optimized for regulatory review, auditing and printing
Jun 2007
Decision
102d
Days
Class 2
Risk

K070675 is an FDA 510(k) clearance 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 Cleared decision on June 22, 2007 after a review of 102 days - within the typical 510(k) review window.

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.

View all Agendia BV devices

FDA 510(k) Submission Details - K070675

510(k) Number K070675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2007
Decision Date June 22, 2007
Days to Decision 102 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 77d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Devices cleared under the same product code (NYI) and FDA review panel - the closest regulatory comparables to K070675.
MAMMAPRINT FFPE
K141142 · Agendia · Jan 2015
PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K141771 · Nanostring Technologies, Inc. · Nov 2014
PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY
K130010 · Nanostring Technologies · Sep 2013
MAMMAPRINT
DEN070009 · Agendia BV · Feb 2007