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The microdot 9 Home Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use only), by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is intended for "single patient-home use" only and should not be shared. It should be used only for testing fresh capillary whole blood samples from a fingerstick or palm for glucose (sugar). Alternate site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. The system consists of the microdot® Home Blood Glucose meter, microdot® Home Test Strips and microdot® Control solutions. microdot® Home Test Strips The microdot® Home Test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick or palm.

The microdot® Home Blood Glucose Monitoring System consists of the microdot® Home Blood Glucose Meter, microdote Home Test Strips, microdot Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. A clear cap is provided with the lancing device for alternate site testing on the palm. microdote Home Blood Glucose Monitoring System is for a single patient use only. The meter and lancing device must not be shared with anyone. microdot® Home is an auto code system. The meter turns on upon insertion of the strip, a blood sample from the finger or palm is applied to the test strip and after 10 seconds, the plasma glucose result is displayed on the screen in mg/dL only. microdot Home Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system, microdot® Xtra Blood Glucose Monitoring System. It relies on quantitative electrochemical biosensor technology to measure current generated on disposable test strips. The strip remains unchanged since the last submission approval, microdot® Xtra Blood Glucose Monitoring System (k083273). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes.

microdot® Xtra Blood Glucose Monitoring System is intended for self testing of qlucose in capillary whole blood from a fingerstick by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is not intended for use on neonates or in the diagnosis of or screening for diabetes mellitus. microdot® Xtra Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. microdot® Xtra Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. microdot® Control solutions are intended for use with microdot® Xtra Blood Glucose Meter and microdot® Xtra Test Strips as a quality control check to verify the accuracy of the blood glucose test results.

The microdot® Xtra Blood Glucose Monitoring System consists of the microdot® Xtra Blood Glucose Meter, microdot® Xtra Test Strips, microdot® Control Solutions and a commercially available (510(k) cleared) lancing device and lancets. The microdot® Xtra Blood Glucose Monitoring System is intended for invitro diagnostic use and for the quantitative measurement of glucose in fresh capillary whole blood. The modified device ie microdor® Xtra Blood Glucose Monitoring System, and its predicate device, microdot® Blood Glucose Monitoring System are intended for use by persons with diabetes or by healthcare professionals in home settings or healthcare facilities. The modified microdot® Xtra Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and specifications as the predicate system. The microdot® Xtra Blood Glucose Monitoring System relies on quantitative electrochemical biosensor technology to measure current generated on disposable test strips. The strip remains unchanged since the last submission approval, microdot® Blood Glucose Monitoring System (k070524). The Test Strip manufacturing and performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose in fresh capillary blood from the fingertip by persons with diabetes or by healthcare professional in home or healthcare facilities. Both the predicate strips, microdor® Test Strips (k070524) and the microdot® Xtra Test Strips use the reagent qlucose dehydrogenase with nicotinamide-adenine dinucleotide as co-factor. The predicate meter uses lot specific calibration code number marked on the strip vial label. The specific code number on the strip vial label allows the meter to convert electrical current into glucose readings via the embedded software in the meter. The user calibrates their meter each time they open a new vial of strips. Each lot of strips is calibrated to give plasma equivalent glucose readings. The meter is turned on by strip insertion, the user applies a drop of blood or control solution to the test strip and the meter starts the measurement. After 10 seconds, the meter displays the glucose concentration and time and date on the LCD display. The microdot® Xtra Blood Glucose Monitoring System is pre-programmed with a predetermined code number, thus removing the requirement to load a code number specific to the strip vial.

microdot Blood Glucose Monitoring System is intended for self testing of glucose in capillary whole blood by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. microdot Blood Glucose Meter The microdot Blood Glucose Meter is intended for the quantitative measurement r fromlers in fresh capillary whole blood from a fingerstick. It is intended for use by persons with diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. microdot Test Strips The microdot Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood from a fingerstick. It is intended for use by o grassowith diabetes or by health care professionals in home settings or healthcare facilities. It is intended for monitoring of blood glucose levels only. microdot Control solutions miorodot oontrol solutions are intended for use with microdot Blood Glucose Meter and microdot Test Strips as a quality control check to verify the accuracy of the blood glucose test results.

The microdot® Blood Glucose System is comprised of the microdot® Meter, Test Strips, & three controls. The test strip is inserted into the device, a drop of blood is added to the strip, and a glucose result is presented in 10 seconds. The test principle is based on electrochemical biosensor technology. Glucose dehydrogenase converts to glucose to gluconolactone, with reduction of NAD to NADH. Re-oxidation of the mediator by the meter induces a micro current to flow, and the size of the micro current is directly proportional to the amount of glucose in the blood. The micro current is detected in of the blood glucose concentration.