510(k) · Cleared
ClearedProsigna Breast Cancer Prognostic Gene Signature Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanostring Technologies, Inc. · NYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
Cleared on Nov 7, 2014 as substantially equivalent to K130010 (Nanostring Technologies, 2013) after a 129-day review. Its family tree reaches back 5 generations to 2007.
- Decided
- Nov 7, 2014
- Review
- 129 days
- Class
- Class II
- Product code
- NYI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070009 (2007). No later device cites it as a predicate yet.
- Root · 5 generations backDEN070009 MammaprintAgendia BV · 2007
- 4 generations backK070675 MammaprintAgendia BV · 2007 · Recalled
- 3 generations backK080252 Modification to MammaprintAgendia BV · 2008 · Recalled
- 2 generations backK081092 Modification to MammaprintAgendia · 2009 · Recalled
- 1 generation backK130010 Prosigna (TM) Breast Cancer Prognostic Gene Signature AssayNanostring Technologies · 2013
- This deviceK141771 Prosigna Breast Cancer Prognostic Gene Signature AssayNanostring Technologies, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070009 | Mammaprint | Agendia BV | 2007 | — |
| −4 | K070675 | Mammaprint | Agendia BV | 2007 | 1 |
| −3 | K080252 | Modification to Mammaprint | Agendia BV | 2008 | 1 |
| −2 | K081092 | Modification to Mammaprint | Agendia | 2009 | 1 |
| −1 | K130010 | Prosigna (TM) Breast Cancer Prognostic Gene Signature Assay | Nanostring Technologies | 2013 | — |
| 0 (this device) | K141771 | Prosigna Breast Cancer Prognostic Gene Signature Assay | Nanostring Technologies, Inc. | 2014 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NYI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NYI device
- #1 K210973 MammaPrint FFPE NGS Kitscore 5.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130010 | Prosigna (TM) Breast Cancer Prognostic Gene Signature AssaySummary page 6…e/high). J. Substantial Equivalence Information: 1. Predicate device name(s): Prosigna™ Breast Cancer Prognostic Gene Signature Assay 2. Predicate 510(k) number(s): k130010 3. Comparison with predicate: Table 1: Comparison with Predicate Prognostic Gene Signature Assay is an in vitro diagnostic ass… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 5 ancestors have a recall of any class.
How does its category compare?
All NYI devicesNYI Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · NYI
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · NYI
Too few NYI 510(k)s in any year since 2007 to give a median.
Recalls per year · NYI
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NYI
1in 2023
MAUDE reports naming product code NYI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Prosigna® Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which is performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, to assess a patient’s risk of distant recurrence of disease. The Prosigna…
Read the full statement (194 words)
The Prosigna® Breast Cancer Prognostic Gene Signature Assay is an in vitro diagnostic assay which is performed on the NanoString nCounter® Dx Analysis System using FFPE breast tumor tissue previously diagnosed as invasive breast carcinoma. This qualitative assay utilizes gene expression data, weighted together with clinical variables to generate a risk category and numerical score, to assess a patient’s risk of distant recurrence of disease.
The Prosigna Breast Cancer Prognostic Gene Signature Assay is indicated in female breast cancer patients who have undergone surgery in conjunction with locoregional treatment consistent with standard of care, either as:
1. A prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors.
2. A prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-positive (1-3 positive nodes), Stage II breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. The device is not intended for patients with 4 or more positive nodes
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141771: Prosigna Breast Cancer Prognostic Gene Signature Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141771
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026