SFU · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.1359
Classification
FDA Product Code
SFU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.1359
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A glucose range monitoring system (GRM) is intended to automatically measure glucose in the body and provide qualitative or semi-quantitative information about glucose levels or trends continuously or frequently. GRM systems are intended to support general user awareness of glucose ranges related to glycemic control. Outputs from GRM systems do not represent quantitative glucose concentration values and GRM systems are not intended to be used for acute medical decision-making, such as insulin dosing or medication adjustment.