SCU

Dna And Rna Oncology Controls

Product code

SCU

Device name

Dna And Rna Oncology Controls

Device class

Class 2

21 CFR

21 CFR 866.5910

Medical specialty

Microbiology

Marketing pathway

510(K) Exempt

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).