FDA product code PNK: Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53)
PNK is the FDA product code for fluorescence in situ hybridization, chromosome 17p deletion (tp53). It is a Class II device, regulated under 21 CFR 864.1890 and reviewed by the Medical Genetics panel. Devices under PNK reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
A chromosome 17p deletion (TP53) fluorescence in situ hybridization (FISH) kit is a test to detect deletion of the TP53 gene in peripheral blood specimens from patients with B-cell chronic lymphocytic leukemia (CLL).
Classification
| Field | Value |
|---|---|
| Device name | Fluorescence In Situ Hybridization, Chromosome 17p Deletion (Tp53) |
| Device class | Class II |
| Regulation | 21 CFR 864.1890 |
| Review panel | MG — Medical Genetics |
| Medical specialty | Pathology |
| Premarket route | 510(k) |
Recalls for PNK devices
openFDA lists no recalls for product code PNK.
Frequently asked questions
What is FDA product code PNK?
PNK is the FDA product code for fluorescence in situ hybridization, chromosome 17p deletion (tp53). It is a Class II device, regulated under 21 CFR 864.1890 and reviewed by the Medical Genetics panel.
What device class is PNK?
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 PNK
- Run a recall and safety report across every PNK manufacturer
- Watch product code PNK 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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