FDA product code NYQ: Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer
NYQ is the FDA product code for chromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer. It is a Class II device, regulated under 21 CFR 864.1890 and reviewed by the Pathology panel. Devices under NYQ reach the market by 510(k); FDA lists no cleared 510(k)s for it. 4 PMA applications cite this product code. FDA has posted 6 recalls for NYQ devices.
Definition
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 qualified pathologist.
Classification
| Field | Value |
|---|---|
| Device name | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
| Device class | Class II |
| Regulation | 21 CFR 864.1890 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
Recalls for NYQ devices
6 product recalls in 5 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-05-05.
| Year | Recalls |
|---|---|
| 2017 | 2 |
Frequently asked questions
What is FDA product code NYQ?
NYQ is the FDA product code for chromogenic in situ hybridization, nucleic acid amplification, her2/neu gene, breast cancer. It is a Class II device, regulated under 21 CFR 864.1890 and reviewed by the Pathology panel.
What device class is NYQ?
Class II, regulation 21 CFR 864.1890. Typical premarket route: 510(k).
Have NYQ devices been recalled?
Yes: 6 product recalls across 5 recall events; the most recent began 2017-05-05.
Next steps
- Run an FDA pathway report with predicate devices for product code NYQ
- Run a recall and safety report across every NYQ manufacturer
- Watch product code NYQ 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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