Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
The Classifier, Prognostic, Recurrence Risk Assessment, RNA Gene Expression, Breast Cancer (product code NYI) is a molecular diagnostic device that uses the gene expression profile of a breast cancer tumor from Stage I or Stage II lymph node-negative patients to provide a prognostic risk assessment for distant recurrence of breast cancer. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 866.6040 within the Immunology specialty. The result is intended for use only in conjunction with other clinical and pathological factors to guide treatment decisions.
Research product code NYI in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NYI
- Device Class
- FDA class 2
- Regulation Number
- 866.6040
- Medical Specialty
- Immunology
- Review Panel
- PA
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K210973 | MammaPrint FFPE NGS Kit | Sep 08, 2022 | Substantially Equivalent | Agendia, Inc. |
| K201902 | MammaPrint | Nov 05, 2020 | Substantially Equivalent | Agendia, Inc. |
| K141142 | MAMMAPRINT FFPE | Jan 23, 2015 | Substantially Equivalent | Agendia |
| K141771 | PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nov 07, 2014 | Substantially Equivalent | Nanostring Technologies, Inc. |
| K130010 | PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Sep 06, 2013 | Substantially Equivalent | Nanostring Technologies |
| K101454 | MAMMAPRINT | Jan 28, 2011 | Substantially Equivalent | Agendia |
| K081092 | MODIFICATION TO MAMMAPRINT | Dec 11, 2009 | Substantially Equivalent | Agendia |
| K080252 | MODIFICATION TO MAMMAPRINT | Jul 21, 2008 | Substantially Equivalent | Agendia BV |
| K070675 | MAMMAPRINT | Jun 22, 2007 | Substantially Equivalent | Agendia BV |
| DEN070009 | MAMMAPRINT | Feb 06, 2007 | Unknown | Agendia BV |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.