Cleared Traditional

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

K201761 · Abbott Diabetes Care, Inc. · Chemistry

Jul 2021

Decision

396d

Days

Class 2

Risk

About This 510(k) Submission

K201761 is an FDA 510(k) clearance for the FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), 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 July 30, 2021, 396 days after receiving the submission on June 29, 2020. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K201761 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2020
Decision Date	July 30, 2021
Days to Decision	396 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.