Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
NYI · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6040
Classification
FDA Product Code
NYI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.6040
Review panel
PA
Medical specialty
Immunology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.