FDA product code NYI: Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer
NYI is the FDA product code for classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer. It is a Class II device, regulated under 21 CFR 866.6040 and reviewed by the Pathology panel. FDA has cleared 9 510(k) submissions under NYI, 1 in the last five years, from 5 different applicants. The average 510(k) review took 268 days (median 246). 1 De Novo request was granted under it. FDA has posted 1 recall for NYI devices.
Definition
A device which uses a gene expression profile of a breast cancer tumor, from patients stage i or stage ii lymph node negative, with a tumor size of <5.0 cm, to provide a risk assessment for distant recurrence of breast cancer. The result is indicated for use only as a prognostic marker by physicians along with a number of other factors to assess the risk of recurrence of breast cancer.
Classification
| Field | Value |
|---|---|
| Device name | Classifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer |
| Device class | Class II |
| Regulation | 21 CFR 866.6040 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
510(k) clearances per year for NYI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 120 |
| 2022 | 1 | 526 |
Compare with all 510(k) review times · Search every NYI clearance
Top NYI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Agendia | 3 | 2015-01-23 |
| Agendia, Inc. | 2 | 2022-09-08 |
| Agendia BV | 2 | 2008-07-21 |
| Nanostring Technologies, Inc. | 1 | 2014-11-07 |
| Nanostring Technologies | 1 | 2013-09-06 |
Most recent NYI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210973 | Agendia, Inc. | MammaPrint FFPE NGS Kit | 2022-09-08 | 526 |
| K201902 | Agendia, Inc. | MammaPrint | 2020-11-05 | 120 |
| K141142 | Agendia | MAMMAPRINT FFPE | 2015-01-23 | 266 |
| K141771 | Nanostring Technologies, Inc. | PROSIGNA BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | 2014-11-07 | 129 |
| K130010 | Nanostring Technologies | PROSIGNA(TM) BREAST CANCER PROGNOSTIC GENE SIGNATURE ASSAY | 2013-09-06 | 246 |
Recalls for NYI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-03-03.
Frequently asked questions
What is FDA product code NYI?
NYI is the FDA product code for classifier, prognostic, recurrence risk assessment, rna gene expression, breast cancer. It is a Class II device, regulated under 21 CFR 866.6040 and reviewed by the Pathology panel.
What device class is NYI?
Class II, regulation 21 CFR 866.6040. Typical premarket route: 510(k).
How long does a 510(k) take for product code NYI?
Across 9 cleared submissions the average was 268 days from receipt to decision (median 246).
Which companies have the most NYI clearances?
Agendia (3); Agendia, Inc. (2); Agendia BV (2); Nanostring Technologies, Inc. (1); Nanostring Technologies (1).
Have NYI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-03-03.
Next steps
- Run an FDA pathway report with predicate devices for product code NYI
- Run a recall and safety report across every NYI manufacturer
- Watch product code NYI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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