Search Results

Diascan Aqueous Glucose Controls are ready to use solutions, which contain a specific amount of glucose. These controls are intended for use with a blood glucose monitoring kit.

Glucose monitoring has become a major adjunct to the care of individuals with diabetes mellitus in the past decade. It is now possible for the individual with diabetes and the health-care professional to measure and record blood glucose levels frequently with portable devices. In the hospital, blood glucose monitor kits are often used instead of routine laboratory glucose testing methods to quickly obtain blood glucose concentrations from patients in the ER, ICU. CCU. OR, or other bedside locations. Used at home, these kits allow individuals with diabetes to monitor and treat fluctuations in blood glucose levels daily.

Diascan Aqueous Glucose Control Low
Diascan Aqueous Glucose Control High

The provided text is related to a 510(k) submission for "Diascan Aqueous Glucose Controls" and details the FDA's decision regarding its substantial equivalence. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The document is a regulatory letter and an "Indication for Use" statement, not a scientific study report.

Therefore, I cannot provide the requested information based on the input text.

Ask a specific question about this device