Modification To MammaPrint
by Agendia United States 510(k)
510(k) K081092 Product code NYI
Overview
The Modification To MammaPrint is a Class II prognostic device that assesses recurrence risk in breast cancer by analyzing RNA gene expression of a defined gene panel. It is classified as a prognostic, recurrence risk assessment test within the immunology specialty and is identified by the FDA product code NYI. The device is listed under the FDA 510(k) traditional clearance pathway with decision date 2009-12-11.
The modification is intended to be used as part of the MammaPrint testing system to update or adjust the assay protocol. It is supplied by Agendia in the Netherlands and is identified by K-number K081092. The device is regulated under FDA 510(k) clearance (decision description: Substantially Equivalent) and is subject to the applicable Class II regulatory requirements.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK081092 | Date11 Dec 2009 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-1321-2010
Over a period of about 6 months in about 15% of results provided Agendia has been "over reporting" the chance of metastasis risk being 29% risk of recurrence instead of 10% risk. This over reporting of risk did not cause direct injury to patients. However, if used by physicians as the sole basis for decision-making, affected patients may have received unnecessary therapy.
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
Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K081092