Cleared Traditional

FreeStyle Libre 3 Continuous Glucose Monitoring System

K212132 · Abbott Diabetes Care, Inc. · Chemistry

May 2022

Decision

322d

Days

Class 2

Risk

About This 510(k) Submission

K212132 is an FDA 510(k) clearance for the FreeStyle Libre 3 Continuous Glucose Monitoring System, a Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (Class II — Special Controls, product code QLG), submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on May 26, 2022, 322 days after receiving the submission on July 8, 2021. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K212132 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2021
Decision Date	May 26, 2022
Days to Decision	322 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QLG — Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1355
Definition	An Integrated Continuous Glucose Monitoring System For Replacement Of Finger Stick Blood Glucose Testing For Diabetes Treatment Decisions In Persons With Diabetes, Unless Otherwise Indicated. The System Automatically Measures Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. The System Is Also Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Devices Where The User Manually Controls Actions For Therapy Decisions. The System Is Not Intended To Be Used With Automated Insulin Dosing (aid) Systems.