FDA product code SCU: Dna And Rna Oncology Controls
SCU is the FDA product code for dna and rna oncology controls. It is a Class II device, regulated under 21 CFR 866.5910 and reviewed by the Medical Genetics panel. Devices under SCU reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Oncology controls are a device intended for use in a next generation sequencing (NGS)-based in vitro diagnostic test system as a quality control to monitor analytical performance of the library preparation, sequencing, and analysis steps of the workflow by detecting systematic analytical deviations that may arise from reagent or instrument variation. This type of device includes synthetic DNA and RNA controls.
Classification
| Field | Value |
|---|---|
| Device name | Dna And Rna Oncology Controls |
| Device class | Class II |
| Regulation | 21 CFR 866.5910 |
| Review panel | MG — Medical Genetics |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Recalls for SCU devices
openFDA lists no recalls for product code SCU.
Frequently asked questions
What is FDA product code SCU?
SCU is the FDA product code for dna and rna oncology controls. It is a Class II device, regulated under 21 CFR 866.5910 and reviewed by the Medical Genetics panel.
What device class is SCU?
Class II, regulation 21 CFR 866.5910. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code SCU
- Run a recall and safety report across every SCU manufacturer
- Watch product code SCU 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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