Dna And Rna Oncology Controls

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown