Cleared Traditional

Lingo Glucose System

K233655 · Abbott · Chemistry
May 2024
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K233655 is an FDA 510(k) clearance for the Lingo Glucose System, a Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter (Class II — Special Controls, product code SAF), submitted by Abbott (Alameda, US). The FDA issued a Cleared decision on May 29, 2024, 197 days after receiving the submission on November 14, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number K233655 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 2023
Decision Date May 29, 2024
Days to Decision 197 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code SAF — Integrated Continuous Glucose Monitor For Non-intensive Glucose Monitoring, Over-the-counter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1355
Definition An Integrated Continuous Glucose Monitoring System (icgm) For Non-intensive Glucose Monitoring Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time To Detect Euglycemic And Dysglycemic Glucose Levels In Persons Who Are Not On Insulin And Do Not Have A Significant Risk Of Problematic Hypoglycemia. Icgm Systems For Non-intensive Glucose Monitoring Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Excluding Devices Intended To Control The Delivery Of Insulin, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices. Device Output Should Not Be Used To Make Treatment Decisions Without Consulting With A Qualified Healthcare Professional.