NYI — Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer Class II
FDA product code NYI covers "Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer", a Class II medical device regulated under 21 CFR 866.6040. Submissions are reviewed by the Immunology panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NYI
- Device Class
- Class II
- Regulation Number
- 866.6040
- Submission Type
- 510(k)
- Review Panel
- PA
- Medical Specialty
- Immunology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K210973 | Agendia | MammaPrint FFPE NGS Kit | Sep 8, 2022 |
| K201902 | Agendia | MammaPrint | Nov 5, 2020 |
| K141142 | Agendia | MAMMAPRINT FFPE | Jan 23, 2015 |
| K141771 | Nanostring Technologies | PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nov 7, 2014 |
| K130010 | Nanostring Technologies | PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Sep 6, 2013 |
| K101454 | Agendia | MAMMAPRINT | Jan 28, 2011 |
| K081092 | Agendia | MODIFICATION TO MAMMAPRINT | Dec 11, 2009 |
| K080252 | Agendia | MODIFICATION TO MAMMAPRINT | Jul 21, 2008 |
| K070675 | Agendia | MAMMAPRINT | Jun 22, 2007 |
| DEN070009 | Agendia | MAMMAPRINT | Feb 6, 2007 |