Cleared Traditional

K141771 - PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY (FDA 510(k) Clearance)

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

K141771 · Nanostring Technologies, Inc. · Pathology device
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Nov 2014
Decision
129d
Days
Class 2
Risk

K141771 is an FDA 510(k) clearance for the PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY. Classified as Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer (product code NYI), Class II - Special Controls.

Submitted by Nanostring Technologies, Inc. (Seattle, US). The FDA issued a Cleared decision on November 7, 2014 after a review of 129 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 Nanostring Technologies, Inc. devices

Submission Details

510(k) Number K141771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2014
Decision Date November 07, 2014
Days to Decision 129 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
52d slower than avg
Panel avg: 77d · This submission: 129d
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.