Cleared Traditional

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

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K193371 · Abbott Diabetes Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
190d
Days
Class 2
Risk

K193371 is an FDA 510(k) clearance for the FreeStyle Libre 2 Flash Glucose Monitoring System. Classified as Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), Class II - Special Controls.

Submitted by Abbott Diabetes Care, Inc. (Alameda, US). The FDA issued a Cleared decision on June 12, 2020 after a review of 190 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1355 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Diabetes Care, Inc. devices

Submission Details

510(k) Number K193371 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 88d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

All 8
Devices cleared under the same product code (QLG) and FDA review panel - the closest regulatory comparables to K193371.
Bigfoot Unity® Diabetes Management System
K222280 · Bigfoot Biomedical, Inc. · Mar 2023
FreeStyle Libre 2 System, FreeStyle Libre 3 System
K223537 · Abbott Diabetes Care, Inc. · Feb 2023
FreeStyle Libre 3 Continuous Glucose Monitoring System
K212132 · Abbott Diabetes Care, Inc. · May 2022
FreeStyle Libre 3 Continuous Glucose Monitoring System
K213996 · Abbott Diabetes Care, Inc. · May 2022
FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K210943 · Abbott Diabetes Care, Inc. · Nov 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · Abbott Diabetes Care, Inc. · Aug 2021