Abstract
In response to Fraeyman et al., 1 Roche blood glucose monitoring systems are fully compliant to all relevant regulatory approval standards and meet established clinical requirements. Blood glucose monitoring systems for hospital or home use available on the market are evaluated and approved according to the DIN EN ISO 15197:2003 standard. Manufacturers of blood glucose monitoring devices have to provide evidence of fulfillment of this standard to obtain clearance for their products. The DIN EN ISO standard states that ‘≥ 95% of the individual glucose results should be within ±0.83 mmol/L (15 mg/dL) of the results of the manufacturer's measurement procedure at glucose concentrations <4.2 mmol/L (75 mg/dL) and within ±20% of the results of the manufacturer's measurement procedure at glucose concentrations ≥4.2 mmol/L’. 2,3 Hence, blood glucose monitoring systems evaluated and cleared according to this quality and regulatory standard deliver accurate results and are safe to use in a hospital and outpatient setting.
Due to its advanced chemistry and compliance with quality and regulatory standards, if used as directed the Accu-Chek Performa/Accu-Chek Inform II blood glucose monitoring systems provide accurate and precise results. Thus, the systems deliver a safe and reliable basis for day-to-day therapeutic decisions for hospital setting and home use.