Noninvasive Glucose? Write an Indications for Use
The effort is in a research phase if the sponsor does not present a formal indications for use (IFU) statement. Here's a helpful link to the FDA's Content of a 510(k); review the Indications For Use Form.
The Indications For Use statements for the glucose monitoring devices from Abbott Diabetes Care Inc. are arranged here in a hierarchy of patient risk from high to low:
Abbott Freestyle Libre 3 Plus: K233537
"The FreeStyle Libre 3 Continuous Glucose Monitoring System is a real time continuous glucose monitoring (CGM) device with alarms capability indicated for the management of diabetes in persons age 2 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments. Interpretation of the System readings should be based on the glucose trends and several sequential readings over time.
The System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The System can be used alone or in conjunction with these digitally connected devices for the purpose of managing diabetes."
Abbott Freestyle Libre Rio: K233861
"The Libre Rio Continuous Glucose Monitoring System is an over-the-counter (OTC) integrated continuous glucose monitoring (iCGM) device indicated for non-insulin using persons age 18 and older.
The System detects trends and tracks patterns and aids in the detection of euglycemia, hyperglycemia, and hypoglycemia. The System is also intended to autonomously communicate with digitally connected devices. "
Lingo Glucose System: K233655
"The Lingo Glucose System is an over-the-counter (OTC) integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze and display glucose values in people 18 years and older not on insulin. The Lingo Glucose System helps to detect euglycemic and dysglycemic glucose levels. The Lingo Glucose System may also help the user better understand how lifestyle and behavior modification, including diet and exercise, impact glucose excursion.
The user is not intended to take medical action based on the device output without consultation with a qualified healthcare professional."
Important: The least patient-risk device, the Lingo Glucose System (an OTC product), is subject to Regulation Number 862.1355. The regulation includes Special Controls covering the (factory-calibrated) sensor performance, validated in clinical investigations using a laboratory reference.
Questions to pose to noninvasive glucose sponsors and alternative glucose monitoring products:
- Share your targeted indications for use statement in the FDA format?
- Share the list of contraindications.
- How does your technology perform with regard to the Special Controls of regulation 862.1355 using a laboratory reference?
- For multivariate spectroscopic methods, share your user-specific calibration process.