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The MyGlucoHealth Wireless System is intended for self-testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of glucose control. The system is comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The system is intended to be used for the quantitative measurement of glucose (sugar) in whole blood samples drawn from the fingertip, ventral palm, hand,upper arm, forearm, calf and/or thigh. The MyGlucoHealth Wireless Meter is intended to be used by a single patient and should not be shared. The MyGlucoHealth Wireless System is not to be used for the diagnosis of or screening for diabetes or for neonatal use. Alternate site testing should be done during steady-state times (when glucose is not changing rapidly).

The MyGlucoHealth Wireless System comprised of the MyGlucoHealth Wireless Meter, MyGlucoHealth Control Solutions and MyGlucoHealth Wireless Test Strip. The MyGlucoHealth Wireless Meter is different from the MyGlucoHealth Blood Glucose Meter (MGH-BT1) only by the way the glucose data is transferred to the data repository. An embedded cellular module within the meter enables Wireless communication between the meter and the Entra Health Systems remote database called MyHealthPoint TeleHealth Manager (K132930). The test strip (proprietary to the MyGlucoHealth Wireless Meter) is used only with the MyGlucoHealth Wireless Meter. It is for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. The MyGlucoHealth Wireless System is not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.

The MyHealthPoint Telehealth Manager is an accessory software that wirelessly collects, records and transmits biometric data (including glucose, blood pressure, weight, body composition, activity, body temperature, ECG and pulse oximeter readings) from a variety of supported home-monitoring devices as well as supporting manual uploading of data. The MyHealthPoint application uses the same data repository platform that is already cleared, MyGlucoHealth Software System (K081703). MyHealthPoint TeleHealth Manager is intended to be used by patients in non-clinical settings (e.g. home) to collect, record and transmit their biometric data to a remote secure server. Stored data is accessible by healthcare professionals and caregivers for analysis, messaging and intervention using standard digital communication technologies and protocols. Patients may also view the data to assist in self-management of their specific health condition. The MyHealthPoint Telehealth Manager is intended to be used in combination with a variety of external vital sign devices. The MyHealthPoint Telehealth Manager is intended to be used by patients identified by their healthcare organization that would benefit from remote monitoring. It is not intended as a replacement of the oversight of healthcare professionals nor does it provide "real-time" or emergency monitoring. It does not measure, interpret or make any decisions on the data that it conveys.

The MyHealthPoint Telehealth Manager is a software platform accessible via PC or mobile smart phone that collects member's biometric data such as activity, blood pressure, blood glucose, ECG, body temperature, body composition/weight and pulse oximetry, and has the ability to send medication reminders. The MyHealthPoint TeleHealth Manager can be used by patients during their daily lives to collect biometric readings from various personal health monitors from a variety of manufacturers to assist in maintaining wellness regimens and the clinical monitoring of patients with chronic disease. The system can be accessed by members, clinicians and caregivers for analysis and intervention using standard digital communication technologies and protocols. The MyHealthPoint Telehealth Manager is intended for use in remote monitoring of patient biometrics and supports messaging between member's, clinicians and caregivers. In addition to monitoring, MyHealthPoint TeleHealth Manager supports reminders, alerts, and online graphical reports to help patients and their healthcare professionals better understand and manage their conditions.

The Myglucohealth glucose monitoring system provides a quick and easy way for diabetic patients to measure and self-monitor blood glucose levels. The system is comprised of the MGH-BT1 (w/Bluetooth wireless download capability) or the MGH-1 (w/o Bluetooth) blood glucose meter, control solution and test strips that carry a biosensor used for the quantitative measurement of the concentration of glucose in capillary whole blood that can be taken from the fingertip, ventral palm, hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. The results obtained are plasma calibrated to allow for easy comparison to the laboratory method. Further, results from either meter may be uploaded to a memory device through a standard RS32 connection, or, with the-BT1 model, wirelessly transmitted to a bluetooth capable PC or Cell phone. The Myglucohealth glucose monitoring systems are not to be used for the diagnosis or screening of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.

Systems are intended for the quantitative measurement of the concentration of glucose in whole blood that can be taken from the fingertip, ventral palm, dorsal hand, upper arm, forearm, calf and/or thigh by diabetic patients or health care professionals. Results are plasma calibrated to allow for easy comparison to lab method. The Myglucohealth glucose monitoring systems are not to be used for the diagnosis of diabetes or for neonatal use. Alternate site testing should be done during steady-state times when glucose is not changing rapidly.