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For use with the AtLast Blood Glucose System for quality control purposes to verify that the AtLast meter and test strips perform well together.

The AtLast Glucose Control Solution is an aqueous control. The control is intended to be used with the Atl.ast Blood Glucose System (AtLast System, K982076) for quality control purposes by the end-user (diabetic consumer). The AtLast System is an over-the-counter (OTC) combination blood sampler and glucose meter that provides blood glucose measurements on samples obtained from various body sites including the forearm, the upper arm, the thigh and the finger tip.

The ATLAST Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in whole blood. It is intended for use by people with diabetes mellitus in the home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates (newborn children). The ATLAST Blood Glucose Monitoring System is specifically indicated for the quantitative measurement of glucose in whole blood samples obtained from the finger, forearm, upper arm and the thigh.

The ATLAST Blood Glucose Monitoring System measures the amount of glucose in capillary whole blood. When whole blood is applied to the ATLAST Test Strip, reagents on the Test Strip react with the blood and a color is formed, the intensity of which is measured by the ATLAST System. The ATLAST Blood Glucose Monitoring System consists of the following components: (1) a reflectance photometer which incorporates a lancing device ("ATLAST System"), (2) glucose reagent test strips ("ATLAST Test Strips") and calibration chip, and (3) sterile lancets ("ATLAST Lancets").