NYI · Class II · 21 CFR 866.6040

FDA Product Code NYI: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

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.

Leading manufacturers include Agendia, Inc..

10
Total
9
Cleared
242d
Avg days
2007
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer Devices (Product Code NYI)

10 devices
1–10 of 10
Cleared Sep 08, 2022
MammaPrint FFPE NGS Kit
K210973
Agendia, Inc.
Pathology · 526d

About Product Code NYI - Regulatory Context

510(k) Submission Activity

10 total 510(k) submissions under product code NYI since 2007, with 9 receiving FDA clearance (average review time: 242 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

NYI devices are reviewed by the Pathology panel. Browse all Pathology devices →