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

NYI is the FDA product code for Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer, a class II device type, regulated under 21 CFR 866.6040. FDA's definition for this code reads: "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...". As of 2026-09-10, FDA records hold 10 510(k) clearances under this code, the most recent dated 2022-09-08, and one recall.