DeviceClearance

Product code NYI— Immunology

MAMMAPRINT

Classification name
Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Device class
Class 2
Regulation
21 CFR 866.6040
Advisory panel
Immunology
Total cleared
10
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code NYI under 21 CFR 866.6040, via openFDA

Market context for product code NYI

FDA has cleared 10 devices under product code NYI between 2007 and 2022, filed by 5 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NYI

Recent clearances under product code NYI

Data sourced from openFDA. This site is unofficial and independent of the FDA.