An online search for a blood-glucose monitoring-system came across the FDA-approved Bluestar app by Welldoc. It is a Class II device (not a combination device) that has proven substantial equivalence under a 510(k) (1). It is intended for adults diagnosed with type II diabetes that is defined as “prescribed mobile therapy” that was successfully implemented to be a more cost-effective method for diagnosing the severity of one’s condition while also setting reminders for a patient to take medication or maintain healthy diet and exercise. Some confusion that can arise in this topic is that the FDA’s approval on the app refers to the app itself, not the monitoring device the pricks the patient. Simply put, the FDA is focused on whether or not the app can properly connect to a blood-glucose meter and transmit data, not on the safety/risk of the meter as it physically analyzes a patient (which has already been established prior to the founding of the app). This may then bring to question as to why a minimally invasive device is labeled as a Class II rather than a Class I, and the reason for that is most likely because the wireless transmission from the device to the app carries risk in itself. If the app misreads the blood-glucose meter or misinterprets the patients blood-sugar levels in any way, then it could result in a patient taking medication that they do not need, or worse, not taking medication that they do need. The FDA requirements are therefore put in place to address that risk and prevent it from occurring.

(1) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162532