NYI

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Product code

NYI

Device name

Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

Device class

Class 2

21 CFR

21 CFR 866.6040

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

10 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).