About Client

A medical device company pioneering the development of a point-of-care blood glucose monitoring device came to Elexes for expert guidance in securing a FDA 510(k) clearance for their device.

Device Overview

The client’s innovative device featured a compact design, allowing users to monitor blood glucose levels conveniently. It included essential accessories like lancets, test strips, and a user-friendly interface for seamless operation. The device came in two configurations, catering to different user preferences and needs.

Our Process

We helped the client build a proper process to accelerate client's journey towards FDA clearance for their new blood glucose monitoring device.

Final Outcome

⦿ Despite some unforeseen challenges, several mitigation strategies employed during testing, coupled with insights gained through the PreSubmission application, led to a successful FDA 510(k) clearance.

⦿ The device's innovative design, compliant packaging, and labeling positioned it for a successful market entry.


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