# K201902: MammaPrint

- Pathway: 510(k) (Traditional)
- Applicant: Agendia, Inc.
- Decided: Nov 5, 2020 after 120 days
- Product code: NYI (Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer)
- Device class: 2
- Regulation: 21 CFR 866.6040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN070009 (2007). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141142: Mammaprint Ffpe, Agendia (2015) Summary page 4.

## Most influential descendants
- K210973: MammaPrint FFPE NGS Kit (2022), 0 descendants of its own

## Indications for use
MammaPrint® FFPE is a qualitative in vitro diagnostic test, performed in a central 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. The test is performed for breast cancer patients, with Stage I or Stage II disease, with tumor size ≤ 5.0 cm and lymph node negative. The MammaPrint FFPE result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors.

Source page: https://510kreport.com/device/K201902
Methodology: https://510kreport.com/methodology