MammaPrint
by Agendia United States 510(k)
510(k) K101454
Product code NYI
Overview
MammaPrint is a prognostic, recurrence risk assessment classifier that utilizes RNA gene expression analysis. It is an in vitro diagnostic test designed to analyze the activity of specific genes in breast cancer tissue samples to assess the risk of cancer recurrence.
The test is performed on formalin-fixed, paraffin-embedded breast cancer tissue samples using next-generation sequencing technology. This device has received FDA 510(k) clearance under K101454.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101454 | Date28 Jan 2011 | StatusActive |
Coverage
- Active
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NYI
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.6040
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Agendia Inc
Questions
What is the primary purpose of the MammaPrint test?
MammaPrint is a prognostic classifier designed to assess the risk of breast cancer recurrence. It functions by analyzing the activity of specific genes within breast cancer tissue samples to provide clinical information regarding potential recurrence.
How is the MammaPrint test performed on tissue samples?
The test utilizes next-generation sequencing technology to perform RNA gene expression analysis. It is specifically designed to be performed on formalin-fixed, paraffin-embedded breast cancer tissue samples.
What is the regulatory status of the MammaPrint device?
MammaPrint has received FDA 510(k) clearance under K101454. This indicates that the device has been reviewed and cleared for use as a prognostic recurrence risk assessment classifier.
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K101454