Modification to Mammaprint

• • 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.

510(k) Number

K080252 ↗

FDA Product Code

NYI

Device Class

Class II

Regulation

21 CFR Part 866.6040

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• MammaPrint FFPE NGS Kit

  Class II

  FDA 510(k) K210973 Active Cleared 8 Sep 2022

• Modification To MammaPrint

  Class II

  FDA 510(k) K081092 Active Cleared 11 Dec 2009

• MammaPrint

  Class II

  FDA 510(k) K201902 Active Cleared 5 Nov 2020

• Mammaprint Ffpe

  Class II

  FDA 510(k) K141142 Active Cleared 23 Jan 2015

• Mammaprint

  Class II

  FDA 510(k) K070675 Active Cleared 22 Jun 2007

• MammaPrint

  Class II

  FDA 510(k) K101454 Active Cleared 28 Jan 2011

See all devices from Agendia Inc →