As of August 2021, the 510(k) submission for the FreeStyle Libre 2 IOS App Glucose Monitoring System designed by Abbott was cleared for market release by the FDA. This groundbreaking device is highly impactful to the diabetes community, offering technically advanced software and digital reliability for continuous glucose monitoring (CGM), packed with numerous capabilities. This system has been engineered to have autonomous communication with digitally connected devices or used alone for monitoring purposes. Compatible insulin pumps already available on the market can be used in conjunction, where the user manually controls actions for therapy decisions. One of the important contradictions of the device is it may not be used with automated insulin dosing systems, including closed-loop and insulin suspend systems.2
The FDA was tasked with evaluating the pioneered technology in the Sensor and LibreLink App for approving the recent 510(k) application. These designed components communicate glucose readings and other information wirelessly and securely to and from interoperable electronic interfaces.2 A unique feature is the LibreLink App will keep records of trends and patterns while incorporating visual graphs and charts for the user to analyze the data and offer early detection for episodes of hyperglycemia and hypoglycemia.1 The Sensor can be worn up to 14 days, disposed of, and replaced with a new one. During adhesion to the skin, a sensor tail is inserted about 5.5 mm into the skin from the guidance of a needle, which is retracted into the applicator after insertion. The phone application labeled as LibreLink is compatible with the Sensor as it interprets in real-time, every minute, the glucose readings along with built-in alerts to warn for customizable highs and lows.2
With the interconnectivity of the Sensor and LibreLink App, and the user’s need for glucose monitoring reliability, the FDA requires substantial evidence and refinement of the quality management system to clear a class II device such as this. A device with cutting-edge technology such as the FreeStyle Libre 2 IOS App Glucose Monitoring System must be subjected to intense testing, risk analysis, and much more to have an opportunity to reach the market. The team at EMMA International has the knowledge to plan for every step in 510(k) submissions for complex, intricate projects such as Abbott’s recently cleared glucose monitoring device. Reach out today to set up a technical call at 248-987-4497 or email us at info@emmainternational.com to learn more about how EMMA International can help with everything quality and regulatory!
[1] Kayla Hui, MPH (2021) Abbott’s Freestyle Libre 2 IOS App Receives FDA Clearance, Retrieved on 3 August 2021 from https://beyondtype1.org/abbott-freestyle-libre-2-app-fda-clearance/
[2] 510(k) Summary (2020) FreeStyle Libre 2 Flash Glucose Monitoring System, Retrieved on 3 August 2021 from https://www.accessdata.fda.gov/cdrh_docs/pdf19/K193371.pdf
