StatStrip® Hospital Glucose Monitoring System

Description

The StatStrip® Hospital Glucose Monitoring System is a portable analyzer designed for bedside glucose testing in clinical environments. It holds FDA clearance specifically for use with critically ill patients, a distinction not granted to other glucose meters. The system measures glucose while automatically correcting for potential interferences such as hematocrit variation and substances like Maltose, which can lead to inaccurate results on other devices. Validation includes an FDA submission study involving over 1,698 critically ill patients with diverse medical conditions and medications. The device requires a 1.2 µl blood sample and has dimensions of 3.1 inches in width, 1.2 inches in depth, and 5.8 inches in height. Using any other glucose meter for critically ill patients is considered an off-label application per FDA guidance.