SCU — Dna And Rna Oncology Controls Class II
FDA product code SCU covers "Dna And Rna Oncology Controls", a Class II medical device regulated under 21 CFR 866.5910. Submissions are reviewed by the Microbiology panel.
Classification Details
- Product Code
- SCU
- Device Class
- Class II
- Regulation Number
- 866.5910
- Submission Type
- Review Panel
- MG
- Medical Specialty
- Microbiology
- Implant
- No
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.