# K210973: MammaPrint FFPE NGS Kit

- Pathway: 510(k) (Traditional)
- Applicant: Agendia, Inc.
- Decided: Sep 8, 2022 after 526 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: 7 generations back to DEN070009 (2007). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201902: MammaPrint, Agendia, Inc. (2020) Summary page 4.

## Indications for use
The MammaPrint FFPE NGS kit is a qualitative in vitro diagnostic test for use by clinical laboratories using target enrichment Next Generation Sequencing (NGS) technology for gene expression profiling of the 70-gene MammaPrint Breast Cancer signature on formalin-fixed, paraffin-embedded (FFPE) breast cancer tissue samples. The test is used to assess a patient’s risk to develop distant metastasis within 5 years and up to 10 years after diagnosis. The MammaPrint FFPE NGS kit is performed for breast cancer patients with Stage I or Stage 1l disease, with tumor size < 5.0 cm and lymph node negative. The test result is indicated for use by physicians as a prognostic marker only, along with other clinicopathological factors.

Source page: https://510kreport.com/device/K210973
Methodology: https://510kreport.com/methodology