NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Immunology · 21 CFR 866.6040 · Class 2
Overview
| Product Code | NYI |
|---|---|
| Device Name | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Regulation | 21 CFR 866.6040 |
| Device Class | Class 2 |
| Review Panel | Immunology |
Identification
A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.
Classification Rationale
Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
Special Controls
The device is classified as Class II under regulation 21 CFR 866.6040 with special controls. The special control guidance document "Class II Special Controls Guidance Document: Gene expression profiling test system for breast cancer prognosis" is available at http://www.fda.gov/cdrh/oivd/guidance/1627.html.
*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K210973 | MammaPrint FFPE NGS Kit | Agendia, Inc. | Sep 8, 2022 | SESE |
| K201902 | MammaPrint | Agendia, Inc. | Nov 5, 2020 | SESE |
| K141142 | MAMMAPRINT FFPE | Agendia | Jan 23, 2015 | SESE |
| K141771 | PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nanostring Technologies, Inc. | Nov 7, 2014 | SESE |
| K130010 | PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nanostring Technologies | Sep 6, 2013 | SESE |
| K101454 | MAMMAPRINT | Agendia | Jan 28, 2011 | SESE |
| K081092 | MODIFICATION TO MAMMAPRINT | Agendia | Dec 11, 2009 | SESE |
| K080252 | MODIFICATION TO MAMMAPRINT | Agendia BV | Jul 21, 2008 | SESE |
| K070675 | MAMMAPRINT | Agendia BV | Jun 22, 2007 | SESE |
| DEN070009 | MAMMAPRINT | Agendia BV | Feb 6, 2007 | DENG |
Top Applicants
- Agendia — 3 clearances
- Agendia BV — 3 clearances
- Agendia, Inc. — 2 clearances
- Nanostring Technologies — 1 clearance
- Nanostring Technologies, Inc. — 1 clearance
