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MAMMAPRINT

by Agendia BV United States 510(k)

510(k) K070675

Product code NYI

Overview

MAMMAPRINT is a genomic test that analyzes the 70 most important genes to provide clear answers regarding the risk of breast cancer recurrence. It is a prognostic classifier that assesses recurrence risk through RNA gene expression analysis. The test is designed to help in the decision-making process for breast cancer treatment by identifying patients who may benefit from more aggressive therapy.

MAMMAPRINT is a laboratory-developed test that is performed in Agendia's specialized laboratory, which meets high standards and undergoes regular monitoring by independent national and international authorities. The test is supplied as a single-use diagnostic tool and is classified under product code NYI with FDA 510(k) clearance (K070675). It is stored in a controlled laboratory environment and is authorized for use in breast cancer recurrence risk assessment.

Summary written by AI from registry data, 25 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070675 Date22 Jun 2007ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-1321-2010 FDA Unclassified (pre-2012) initiated 3 Mar 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) · synced 6 Oct 2026

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

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Questions

  • What is MAMMAPRINT used for?

    MAMMAPRINT is a genomic test that analyzes the 70 most important genes to provide clear answers regarding the risk of breast cancer recurrence. It helps clinicians make informed decisions about breast cancer treatment by identifying patients who may benefit from more aggressive therapy.

  • How is MAMMAPRINT supplied and stored?

    MAMMAPRINT is supplied as a single-use diagnostic tool and is stored in a controlled laboratory environment. It is a laboratory-developed test performed in Agendia's specialized laboratory, which meets high standards and undergoes regular monitoring by independent authorities.

  • What is the regulatory status of MAMMAPRINT?

    MAMMAPRINT has FDA 510(k) clearance with K number K070675 and is classified under product code NYI. It is authorized for use in breast cancer recurrence risk assessment and is classified as a Class II device.

  • How does MAMMAPRINT work?

    MAMMAPRINT works as a prognostic classifier that assesses recurrence risk through RNA gene expression analysis. By examining the expression of 70 key genes, it provides a clear assessment of the risk of breast cancer recurrence, which can guide treatment decisions.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K070675 24 fields · synced 6 Oct 2026