MammaPrint FFPE

Basic Information

• Brand Name: MammaPrint FFPE
• Primary DI: 00850024841321
• Version / Model: MammaPrint FFPE Microarray
• Company Name: Agendia, Inc.
• Labeler DUNS: 021556144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-14
• Public Version: 1
• Public Version Date: 2026-04-22
• Public Version Status: New
• Public Device Record Key: c5118333-e658-482e-b258-015c28f13c09

Device Description

MammaPrint® FFPE is a qualitative, non-automated in vitro diagnostic test, performed in a Agendia’s Diagnostic Service Laboratory, using the gene expression profile obtained from formalin-fixed paraffin embedded (FFPE) breast cancer tissue samples to assess a patient’s risk for distant metastasis within 5 years. MammaPrint provides prognostic information regarding patient’s risk of distant metastasis and prediction of the magnitude of systemic therapy benefit to guide treatment decisions in patients with breast cancer. The MammaPrint genes measure the characteristics of the multiple step development of breast cancer cells to survive, proliferate, disseminate and metastasize as covered within the hallmarks of cancer. The test is performed for female breast cancer patients, Stage I or Stage II disease who are lymph node negative or lymph node positive with up to 3 positive nodes and for patients with stage III disease. The MammaPrint® FFPE result is indicated for use by physicians and should be interpreted along with other clinico-pathological factors.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NYI	Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer	Immunology	866.6040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60943	Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended for the qualitative and/or quantitative detection of mRNA expression and/or determination of the gene mutation status of multiple genes associated with cancer in a clinical specimen, using a nucleic acid technique (NAT). It is intended to be used to select treatment options, predict or monitor the response to cancer therapy and the risk of recurrence or metastasis, and/or for tumour profiling (e.g., cell-free DNA or circulating tumour DNA screening).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850024841321	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K201902	000