QIG · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.5910
Classification
FDA Product Code
QIG
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
RNA quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision or sample concentration and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic RNA controls and cell-line based controls.