Cleared Traditional

K193371 - FreeStyle Libre 2 Flash Glucose Monitoring System
(FDA 510(k) Clearance)

K193371 · Abbott Diabetes Care, Inc. · Chemistry
Jun 2020
Decision
190d
Days
Class 2
Risk

K193371 is an FDA 510(k) clearance for the FreeStyle Libre 2 Flash 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 June 12, 2020, 190 days after receiving the submission on December 5, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number K193371 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2019
Decision Date June 12, 2020
Days to Decision 190 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.

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