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The ARKRAY Diabetes Management Software is an optional accessory for use with compatible blood glucose meters, such as ARKRAY Glucocard Vital Blood Glucose Meter with data management capabilities. The ARKRAY Diabetes Management Software transfers data from the meter's memory into a secured sever for enhanced data management. ARKRAY ARK Care™ Diabetes Management System is intended for use in home and clinical settings via the internet to assist people with diabetes and their healthcare professionals in uploading, storing, analyzing, and communicating about historical blood glucose test results and other biological statistics to support diabetes management.

ARK Care system serves as an interface between the software in personal glucose monitoring devices and a general purpose health management database to assist in the review, analysis and evaluation of blood glucose test results. The secure system is compliant with HIPAA and HITECH standards. ARK Care is designed for home use and professional healthcare settings. It is an accessory device to most manufactured model home-use blood glucose monitors, including glucose monitoring devices by ARKRAY, Roche, Bayer, LifeScan, and Abbott. The list of supported devices is located at www.arkcare.net. The purpose of the electronic diabetes management system is to help users and healthcare teams manage blood glucose information to better regulate diabetes treatments and control blood glucose for better health outcomes. The ARK Care system holds a convenience function, as the user can upload blood glucose data from a variety of currently marketed blood glucose monitors into one location for viewing. After the user transmits and stores blood glucose data to the secure database, the ARK Care system allows family members and/or healthcare professionals to view and monitor the user's data and reports. Family and healthcare team members must receive permission from the primary user and create a password protected login before viewing data. ARK Care provides a safe communication portal for the user, family, and healthcare team to send email-like entries, improving patient care and disease management. The user and approved healthcare team members can view the blood glucose data in different formats such as logbooks, charts, and graphs. The data can be viewed through selected time intervals and these intervals can be compared over time to track disease management. The subject can also enter and track other health-related information such as body weight, blood pressure, lab values, and exercise activities. Groups of profiles can be queried for bulk reporting on data related to tracking and trending of outcomes, supporting diabetes disease management in individuals and in managed care organizations.

The ARKRAY Diabetes Data Management Software (SMBG Viewer) is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The ARKRAY Diabetes Data Management Software transfers data from the meter's memory into a computer for enhanced data management. The ARKRAY Diabetes Data Management Software is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

The ARKRAY Diabetes Data Management Software is an optional accessory for use with ARKRAY blood glucose meters with data management capabilities. The subject device consists of a USB data transfer cable and software. The system allows the user to download blood glucose results from their glucose meter to their computer, maintain a history of their glucose test results, and convert them into graphs, charts and reports. The software does not recommend any medical treatment or medication dosage level.

The Assure Platinum Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The Assure Platinum Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Assure Platinum Blood Glucose Meter: The Assure Platinum Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. Assure Platinum Blood Glucose Test Strips: Assure Platinum test strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips when used with the Assure Platinum Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use in home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. Assure Dose CONTROL: For use with Assure Platinum Blood Glucose Meter and Assure Platinum Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in two levels - Normal (Level 1) and High (Level 2).

The Assure Platinum Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.

The GLUCOCARD® Vital™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The GLUCOCARD® Vital™ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The GLUCOCARD® Vital™ Blood Glucose Monitoring System consist of a meter, test strips, and control solution for use as an aid to monitor the effectiveness of diabetes control.

The PocketChem EZ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips and palms. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The PocketChem EZ Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The PocketChem EZ Blood Glucose Monitoring System consists of a meter, test strips, and two levels of control solutions for use as an aid to monitor the effectiveness of diabetes control.

The Assure Pro Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. The Assure Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The Assure Pro Blood Glucose Monitoring System consists of a meter, test strips, and two levels of control solutions for use as an aid to monitor the effectiveness of diabetes control.

The GLUCOCARD™ 01-mini Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

GLUCOCARD™ 01-mini consists of a meter, test strips, and control solutions for use in measuring blood glucose as an aid to monitor the effectiveness of diabetes control.

The GLUCOCARD™ 01 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. GLUCOCARD™ 01 Blood Glucose Meter: The GLUCOCARD™ 01 Blood Glucose Meter is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or palm. GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the GLUCOCARD™ 01 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips: GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, or GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips must be used with the palm. GLUCOCARD™ 01 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). They are indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. CIECOCARD" 01 CONTROLA For use with GLUCOCARD™ 01 Blood Glucose Meter and GLUCOCARD™ 01 SENSOR Blood Glucose Test Strips as a quality control check to verify the accuracy of blood glucose test results. Control solutions are available in three levels - Low (L), Normal (N) and High (H).

The GLUCOCARD 01 Blood Glucose Monitoring System consists of a meter, sensor test strips, and control solutions for use as an aid to monitor the effectiveness of diabetes control.

The GLUCOCARD X-METER Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm or palm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The GLUCOCARD X-METER Blood Glucose Monitoring System consists of a meter, sensor test strips, and control solutions for use as an aid to monitor the effectiveness of diabetes control.