FDA product code · Pathology
Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
4 FDA decisions since 2008. 1 recall names this code; it is not Class I.
This device is intended to detect her2 gene amplification in formalin-fixed, paraffin-embedded breast carcinoma tissue sections using chromogenic in situ hybridization and brightfield microscopy. Indicated as an aid in the assessment of patients for whom herceptin. (trastuzumab) treatment is being considered. Interpretation of test results must be made within the context of the patients clinical history by a…
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly Download the data (CSV)
Twenty years of NYQ at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.
FDA decisions per year · NYQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NYQ
Too few NYQ 510(k)s in any year since 2007 to give a median.
Recalls per year · NYQ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NYQ
2in 2016
MAUDE reports naming product code NYQ, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | — | 1 | 0 |
| 2012 | 7 | — | 0 | 0 |
| 2013 | 11 | — | 0 | 0 |
| 2014 | 7 | — | 0 | 7 |
| 2015 | 5 | — | 0 | 0 |
| 2016 | 5 | — | 0 | 2 |
| 2017 | 5 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 4 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 6 | — | 0 | 0 |
| 2023 | 4 | — | 0 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 3 | — | 0 | 0 |
| 2026 | 2 | — | 0 | — |
Planning a device in NYQ? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportRelated product codes
Other codes under 21 CFR 864.1890.