FDA product code OWE: Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement
OWE is the FDA product code for fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement. It is a Class II device, regulated under 21 CFR 864.1890 and reviewed by the Pathology panel. Devices under OWE reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
Anaplastic lymphoma kinase (ALK) fluorescence in situ hybridization (FISH) kit is to detect rearrangements involving the ALK gene in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens. It is indicated to aid in the selection of patients for treatment with specific FDA approved therapeutic drugs.
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement |
| Device class | Class II |
| Regulation | 21 CFR 864.1890 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
Recalls for OWE devices
openFDA lists no recalls for product code OWE.
Frequently asked questions
What is FDA product code OWE?
OWE is the FDA product code for fluorescence in situ hybridization, anaplastic lymphoma kinase, gene rearrangement. It is a Class II device, regulated under 21 CFR 864.1890 and reviewed by the Pathology panel.
What device class is OWE?
Class II, regulation 21 CFR 864.1890. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code OWE
- Run a recall and safety report across every OWE manufacturer
- Watch product code OWE 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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