Cleared Traditional

FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System

K223435 · Abbott Diabetes Care, Inc. · Chemistry

Apr 2023

Decision

150d

Days

Class 2

Risk

About This 510(k) Submission

K223435 is an FDA 510(k) clearance for the FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System, a Integrated Continuous Glucose Monitoring System, Factory Calibrated (Class II — Special Controls, product code QBJ), submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on April 13, 2023, 150 days after receiving the submission on November 14, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K223435 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 14, 2022
Decision Date	April 13, 2023
Days to Decision	150 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QBJ — Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1355
Definition	An Integrated Continuous Glucose Monitoring System (icgm) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control.