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The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. Testing is done outside of the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

The WaveSense Jazz Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device lancets, control solution and instructions for use. Test Strips are necessary for testing but are sold separately. The WaveSense Jazz Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertips, palm or forearm. The WaveSense Jazz Test Strips are for in vitro diagnostic (outside of the body) use only. The WaveSense Jazz System is not intended for use with neonates.

The One Drop Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop Blood Glucose Monitoring 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 diabetes control. The One Drop Blood Glucose Monitoring System is not for the diagnosis of, or diabetes, and is not intended for use with neonates. The One Drop Blood Glucose Test Strips: The One Drop Blood Glucose Test Strips are for use with the One Drop Blood Glucose Meter to quantitatively measure blood glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

The One Drop Blood Glucose Monitoring System (BGMS) is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The One Drop BGMS 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 diabetes control. The System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The system measures the concentration of glucose in a drop of blood obtained from the fingertip. The test strip is inserted into the meter and the blood is then introduced to the tip of the test strip. The blood reacts with chemicals on the test strip and this reaction generates an electrical current which is measured by the meter. The magnitude of the current is related to the blood glucose concentration. The fundamental scientific technology and the electronics that sends the electrical signals to the assay algorithm are all the same as the predicate device AgaMatrix Jazz Wireless 2 BGMS (K152365). The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user. The One Drop Blood Glucose Monitoring System (BGMS) consists of: - 1 One Drop Blood Glucose Meter ● - 1 One Drop Owner's Guide ● - 1 Carry Case - 1 Lancing Device - 10 Lancets - 100 One Drop Glucose Test Strips ● - AgaMatrix Glucose Control Solution (available separately) ●

The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose (sugar) levels in fresh capillary whole blood samples drawn from the fingertip. It is intended to be used by a single patient and should not be shared. The AgaMatrix Jazz ™ Wireless 2 Blood Glucose Monitoring System is intended for selftesting outside the body (In vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The AgaMatrix Jazz™ Blood Glucose Test Strips are for use with the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip.

The AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System includes the AgaMatrix Jazz™ Wireless 2 Blood Glucose Meter and the AgaMatrix Jazz™ Blood Glucose Test Strips. The apply blood symbol is displayed for the user to apply blood to the test strip until the meter begins the test. When enough blood has been applied to the strip electrodes the meter detects trigger current from the test strip initiating the test countdown. When the countdown is complete a test result is displayed on the meter screen. The unit of measure displayed on the meter screen is fixed in mg/dL and cannot be modified by the user. The following items are included in the AgaMatrix Jazz™ Wireless 2 Blood Glucose Monitoring System: - 1 AgaMatrix Jazz™ Wireless 2 Glucose Meter . - . 1 Owner's Guide - . 1 Carry Case - 1 AgaMatrix Lancing Device . - . 10 AgaMatrix Lancets - AgaMatrix Jazz™ Blood Glucose Test Strips - - -1 Meter Pairing & Syncing Guide The following items are compatible with the AgaMatrix Jazz™ Wireless 2 Glucose Monitoring System and are available separately: - . AgaMatrix Glucose Control Solutions (cleared in K103544) - AgaMatrix Diabetes Manager Mobile Application (cleared in K132821) -

The AgaMatrix Health Manager is intended for single patient use. It is an accessory to blood glucose monitoring systems to assist in the review, analysis and evaluation of glucose results to aid in diabetes and health management. The AgaMatrix Health Manager collects data from AgaMatrix manufactured glucose meters and allows adding, editing, and viewing additional health data. The AgaMatrix Health Manager is not intended to provide automated treatment guidance or decisions, nor is it to be used as a substitute for professional healthcare advice.

The AgaMatrix Health Manager (app) is an optional software accessory for blood glucose meters manufactured by AgaMatrix. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the app installed on an iPhone or iPod touch from the AgaMatrix meter by using the AgaMatrix Cable to connect the meter to the connector of the iPhone or iPod touch. The app will allow the user to manually enter carbohydrate, insulin, and weight information. Users will have the ability to have their data from the AgaMatrix Health Manager automatically uploaded to the AgaMatrix Health Manager cloud portal for back-up. The cloud portal will enable access to the health information in a web browser. Users will have the ability to create and edit their profile, set goals, and download their information as a .csv file.

The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels from fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be shared. The iBGStar™ Blood Glucose Monitoring 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 diabetes control. The iBGStar™ Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. The iBGStar Diabetes Manager Application is intended for use in the home with the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.

The iBGStar Blood Glucose Monitoring System (BGMS) consists of: - iBGStar Blood Glucose Meter . - . BGStar Test Strips - BGStar Control Solution . The iBGStar. Diabetes Manager Application (DMA) is an optional software accessory for the iBGStar Blood Glucose Monitoring System. It is a digital logbook and diabetes tool designed to operate using an iPhone or iPod touch. An individual can manually enter blood glucose readings or can download readings directly to the DMA installed on an iPhone or iPod touch from the iBGStar meter.

The iBGStar™ Blood Glucose Monitoring System is intended for the quantitative measurement of blood glucose levels in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. It is intended to be used by a single patient and should not be used for testing multiple patients. The iBGStar™ Blood Glucose Monitoring 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 diabetes control. The iBGstar Blood Glucose Monitoring System is not for the diagnosis of, or screening for diabetes, and is not intended for use with neonates. BGStar™ Test Strips are for use with the iBGStar™ Blood Glucose Meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from the fingertip, palms (at the base of the thumb), or forearms. Palm and foream testing (Alternative Site Testing) should be done only during steady-state times (when glucose is not changing rapidly). BGStar Control Solutions are for use with the iBGStar™ Blood Glucose Meter and BGStar Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly. The iBGStar Diabetes Manager Application is intended for use in the capability of sending glucose readings through email to an individual's healthcare professional in the review, analysis and evaluation of glucose test results to support an effective diabetes management program. It is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.

The iBGStar Blood Glucose Monitoring System consists of: iBGStar Blood Glucose Meter, BGStar Test Strips, BGStar Control Solution. The iBGStar Diabetes Manager Application is an optional data management software accessory for use with the iBGStar Blood Glucose Monitoring System.

The WaveSense Diabetes Manager (WDM) application (app) is intended for use in the home and professional settings to aid individuals with diabetes and their healthcare professionals; in the review, analysis and evaluation of blood glucose readings to support an effective diabetes management program. The WaveSense Diabetes Manager application is a digital logbook and diabetes management tool designed to operate using the iPhone Operating System platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled blood glucose meter (BGM) with a mini-USB port.

The WaveSense Diabetes Manager (WDM) application (app) is a digital logbook and diabetes management tool for the iPhone operating system platform. The application can be used alone or with the WaveSense Direct Connect Cable and a WaveSense-enabled Blood Glucose Meter (BGM) with a mini-USB port.

AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix WaveSense™ Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless " Test Strips as a quality control check to verify the accuracy of blood glucose test results.

The AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System which is codeless, includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips and control solution are sold separately. It is intended for over-the counter home use by diabetics to monitor their blood glucose levels or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument. The modification of Jazz Wireless™ blood glucose system allows users to upload glucose readings from the meter to a blue tooth enabled PC without the use of a USB cable.

AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

The AgaMatrix WaveSense™ KeyNote Codeless Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips are sold separately. The meter is a portable, battery-operated instrument.

AgaMatrix JAZZ™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix JAZZ™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ™ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm, and/or forearm. 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix JAZZ™ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ™ Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood from the finger stick, palm and/or forearm. 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 a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control. AgaMatrix JAZZ™ Control Solutions are intended for use with the AgaMatrix JAZZ™ Meter and AgaMatrix JAZZ™ Test Strips as a quality control check to verify the accuracy of blood glucose test results.

The AgaMatrix WaveSense JAZZ™ Blood Glucose Monitoring System includes a meter with batteries, compact carrying case, Lancing device, lancets, control solution and owner's booklet. Test Strips are sold separately. It is intended for over-the-counter home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.