# Dna And Rna Oncology Controls
> **Product code: SCU** · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.5910
## Classification
- **FDA Product Code:** SCU
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.5910
- **Review panel:** MG
- **Medical specialty:** Microbiology
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 1
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=SCU)
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