Browse hierarchy: [Immunology (IM)](/submissions/IM) → [Subpart G — Tumor Associated Antigen Immunological Test Systems](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems) → [21 CFR 866.6040](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6040) → NYI — Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

# NYI · Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer

_Immunology · 21 CFR 866.6040 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI

## Overview

- **Product Code:** NYI
- **Device Name:** Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
- **Regulation:** [21 CFR 866.6040](/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/866.6040)
- **Device Class:** 2
- **Review Panel:** [Immunology](/submissions/IM)

## Identification

A gene expression profiling test system for breast cancer prognosis is a device that measures the ribonucleic acid (RNA) expression level of multiple genes and combines this information to yield a signature (pattern or classifier or index) to aid in prognosis of previously diagnosed breast cancer.

## Classification Rationale

Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.

## Special Controls

The device is classified as Class II under regulation 21 CFR 866.6040 with special controls. The special control guidance document "Class II Special Controls Guidance Document: Gene expression profiling test system for breast cancer prognosis" is available at http://www.fda.gov/cdrh/oivd/guidance/1627.html.

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Gene Expression Profiling Test System for Breast Cancer Prognosis.” See § 866.1(e) for the availability of this guidance document.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K210973](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K210973.md) | MammaPrint FFPE NGS Kit | Agendia, Inc. | Sep 8, 2022 | SESE |
| [K201902](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K201902.md) | MammaPrint | Agendia, Inc. | Nov 5, 2020 | SESE |
| [K141142](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K141142.md) | MAMMAPRINT FFPE | Agendia | Jan 23, 2015 | SESE |
| [K141771](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K141771.md) | PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nanostring Technologies, Inc. | Nov 7, 2014 | SESE |
| [K130010](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K130010.md) | PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | Nanostring Technologies | Sep 6, 2013 | SESE |
| [K101454](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K101454.md) | MAMMAPRINT | Agendia | Jan 28, 2011 | SESE |
| [K081092](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K081092.md) | MODIFICATION TO MAMMAPRINT | Agendia | Dec 11, 2009 | SESE |
| [K080252](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K080252.md) | MODIFICATION TO MAMMAPRINT | Agendia BV | Jul 21, 2008 | SESE |
| [K070675](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/K070675.md) | MAMMAPRINT | Agendia BV | Jun 22, 2007 | SESE |
| [DEN070009](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI/DEN070009.md) | MAMMAPRINT | Agendia BV | Feb 6, 2007 | DENG |

## Top Applicants

- Agendia — 3 clearances
- Agendia BV — 3 clearances
- Agendia, Inc. — 2 clearances
- Nanostring Technologies — 1 clearance
- Nanostring Technologies, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI](https://fda.innolitics.com/submissions/IM/subpart-g%E2%80%94tumor-associated-antigen-immunological-test-systems/NYI)

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