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The XPER Technology PREMIUM Pro Blood Glucose Monitoring System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in fresh capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories. The system should only be used with single-use, auto-disabling lancing devices when performing a fresh capillary whole blood sample from the fingertip. The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The system is not intended for use on patients receiving intensive medical intervention/therapy. The system is not intended for use in acute care, nursing facilities, skilled nursing facilities or hospital settings. The system is not intended for use on neonates.

The XPER Technology PREMIUM Pro Blood Glucose Monitoring System consists of the XPER Technology PREMIUM Pro Blood Glucose Meter, the XPER Technology PREMIUM Pro Blood Glucose Test Strips, and the TaiDoc Blood Glucose Control Solutions. This system is a multiplepatient use for the quantitative determination of glucose in capillary whole blood samples from the fingertips in endocrinology clinic laboratories and physician office laboratories as an aid in monitoring the effectiveness of glucose control. The TaiDoc Blood Glucose Control Solutions are used to check that the meter and test strips are working together properly.

The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonatal heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonatal heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia. The StatStrip Glucose Hospital Meter System includes the following components: - StatStrip Glucose Hospital Meter - StatStrip Glucose Test Strips

StatStrip Glucose Hospital Meter System: The StatStrip Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated color touch-screen Graphical User Interface (GUI). StatStrip Glucose Test Strips: The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricyanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step provides a blood glucose result. Test strips will be sold in vials of 25 strips. StatStrip Glucose Control Solutions: The control solutions are aqueous assayed solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter. StatStrip Glucose Linearity Solutions: There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dve). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system. Charging (Docking) Station: The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed and charged wirelessly. The charging station should be located central to the patient care area being served by the meter (e.g., a nursing station). The data charging station must remain plugged in to a wall outlet for power. The system still allows the charging station to be used to transfer data from the meter to a central workstation and allow meter setup information to be downloaded from the central workstation to the meter.

The Assure Titanium Blood Glucose Monitoring System consists of the Assure Titanium Blood Glucose meter and the Assure Titanium Blood Glucose test strips. The Assure Titanium Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips. The system is intended for in vitro diagnostic, point of care use in endocrinology clinics and nursing facilities, for multiple patient use. This system should only be use, auto-disabling lancing devices for drawing finger stick capillary blood. The system is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia. The system is not intended for use in acute care or hospital settings. The system is not intended for neonatal use. The system is for prescription use only.

The Assure Titanium Blood Glucose Monitoring System consists of a battery-powered meter, disposable test strips Assure Titanium Blood Glucose Test Strips, and control solutions. The Assure Titanium Blood Glucose Test Strips utilizes biosensor technology for the quantitative determination of glucose concentrations in capillary blood samples. Glucose in the blood reacts with the reagent in the test strip, and this produces a small electric current (amperometry). The strength of this current is proportional to the concentration of glucose in the blood. The meter measures this current and calculates the patient's glucose level.

The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens throughout all hospital and all professional healtheare settings, including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Xpress 2 Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, a Quality Control (QC) solution, linearity, or proficiency solutions. In addition to measuring glucose, the meter stores patient test data, and other information relating to patient sample, operator, reagents, and the meter. The meter can store up to 400 patient and/or quality control test results. The user can review all stored test results on screen. Functions and data selection are accomplished by 3 push buttons. The meter has a built-in beeper for audible alerts and prompts. The StatStrip Glucose Hospital Meter Test Strips are intended for use with the StatStrip Xpress 2 Glucose Hospital Meter System. The Nova StatStrip Glucose Control Solutions are used as a quality control check to ensure that the StatStrip Xpress 2 Glucose Hospital Meter and the Glucose Test Strips are working properly as a system. The Nova StatStrip Glucose Linearity Solutions are used to check the linearity of the Nova StatStrip Xpress 2 Glucose Hospital Meter.

The StatStrip Xpress Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood, and neonate heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Xpress Glucose Hospital Meter is a hand-held, battery-powered, in vitro diagnostic laboratory instrument that works in conjunction with Nova Biomedical glucose electrochemical test strips to measure glucose in a whole blood sample, Quality Control (QC), linearity, or proficiency solutions. In addition to measuring glucose, the meter stores patient test data, and other information relating to patient sample, operator, reagents, and the meter. The meter can store up to 400 patient and/or quality control test results. The user can review all stored test results on screen. Functions and data selection are accomplished by 3 push buttons. The meter has a built-in beeper for audible alerts and prompts. The StatStrip Glucose Hospital Meter Test Strips are intended for use with the StatStrip Xpress Glucose Hospital Meter System. The Nova StatStrip Glucose Control Solutions are used as a quality control check to ensure that the StatStrip Xpress Glucose Hospital Meter and the Glucose Test Strips are working properly as a system. The Nova StatStrip Glucose Linearity Solutions are used to check the linearity of the Nova StatStrip Xpress Glucose Hospital Meter.

The StatStrip Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, neonate arterial whole blood, and neonate heel stick specimens throughout all hospital and all professional healthcare settings, including patients receiving intensive medical intervention/therapy. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Glucose Hospital Meter System was previously cleared under K150281. The purpose of this dual 510(k) and CLIA Waiver submission for the StatStrip Glucose Hospital Meter System is to expand the indication for use to include the use of capillary specimens on patients receiving intensive medical intervention/therapy and support a CLA Waived categorization for this expanded indication for use to include the quantitative determination of glucose in capillary finger stick throughout all hospital and all professional healthcare settings. No changes have been made to the software, the test strips, controls or linearity solutions. The system contains the following: - 1. StatStrip Meter, with integrated Wi-Fi connection and antenna option - 2. Charging Station - 3. Vial of StatStrip Test Strips - 4. Battery (3.7 V Lithium) - 5. Quick Reference Guide - 6. Instructions for Use Manual - 7. StatStrip Log Book Offered separately: - . StatStrip Test Strips - Quality Control Solutions, Level 1, 2, 3 - Linearity Solutions, Levels 1, 2, 3, 4, 5. Meter: The StatStrip Glucose Hospital Meter is a hand-held testing device that works in conjunction with Nova StatStrip Glucose test strips to measure glucose in a whole blood sample. Meter operation is selfprompting using an illuminated touch-screen Graphical User Interface (GUI). In addition to measuring glucose, the meter also stores patient test data, quality control test data and other information relating to the patient, patient sample, operator, reagents and meter. The self-prompting menu system is navigated by means of a combination of touch-panel on-screen keys, on-screen soft keyboard. The operator can use a finger or a PDA stylus to select options for the onscreen display. It offers audible feedback for user inputs, and audible and/or visual feedback for prompts and user alerts. The Meter also has a barcode scanner that automates data entry. The rechargeable batteries provide sufficient power to operate for 8 hours before requiring recharging. A "battery fuel gauge" bitmap constantly informs the user as to the current state of charge on the battery. Battery charge state information is available on the "meter Welcome screen". The meter will shutoff (Sleep) after 90 seconds of inactivity. Test data and meter setup information will be stored in a nonvolatile form to prevent data loss. Charging (Docking) Station: The meter charging station is a stationary accessory used to recharge the meter. The charging station has one slot for the meter to be placed for charging and a slot for an extra battery to be charged. The charging station should be located central to the patient care area being served by the meter (e.g. a nursing station). The data charging station must remain plugged in to a wall outlet for power. The system still allows the charging station to be used to transfer data from the meter to a central workstation, and allow meter setup information to be downloaded from the central workstation to the meter. Test Strips: The test strips contain a reaction layer that contains a glucose-enzyme (greater than 1.0 IU) and ferricvanide as a mediator. The test strip is touched to a drop of blood to initiate the test process. The strip is designed such that when a drop of blood is touched to the strip, the blood is drawn into the reaction space via capillary action. A simple one-step process provides a blood glucose result. Test strips will be sold in vials of 25 strips. Control Solutions: The control solutions are aqueous assayed solutions, containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. There are three levels of controls, (Level 1, Level 2 and Level 3). These solutions will be offered for sale separately from the meter. Linearity Solutions: There are 5 levels of Linearity solutions containing buffered D-Glucose, viscosity-adjusting agent, preservatives and other non-reactive ingredients (dye). They contain no products of human origin. These solutions are offered separately from the system for users to verify the performance of the system. Replacement batteries will be offered separately. Wi-Fi Option: The StatStrip Glucose Hospital Meter provides a Wi-Fi communication method with a healthcare facility's network system. The wireless radio chipset utilizing the IEEE 802.11 alb/g communication protocols (Wi-Fi) is used as an optional means to transmit and receive test results, previously cleared under K150281.

The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnosic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, neonate arterial whole blood and neonate heel stick specimens. The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.

The Nova Biomedical StatStrip Xpress 2 Glucose Hospital Meter System consists of a hand held meter, test strips, control solutions, and linearity solutions. The test strip contains a reagent (glucose oxidase) that reacts with the glucose in the test sample is applied to the test strip, which is then analyzed in the meter. The reagent test strip contains glucose oxidase and glucose dehydrogenase, which reacts with the glucose in the test sample. A test strip is inserted into the meter, and the sample is applied to the sample entry end of the strip. When enough sample has been added to the strip (sample is drawn into strip though capillary action) the meter begins its analysis. A digital readout is displayed on the meter in 6 seconds. The system is designed for hospital point of care (POC) use including physicians' office labs.

The StatStrip Xpress Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, areonate arterial whole blood and neonate heel stick specimens. The StatStrip Xpress Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal arterial samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. It is not intended for use with neonate cord blood specimens. It is not intended for the screening or diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Xpress Glucose Hospital Meter System is a hand-held testing device that works in conjunction with the StatStrip Glucose Test Strips. Meter operation is self-prompting using a segmented liquid crystal display (LCD) and icons. Function and data selection is accomplished using 3 push buttons. The handheld meter supports audible alerts and prompts with a built-in beeper. In addition to measuring glucose, the meter also stores up to 400 patient test records. The user can recall and review test results. A single coin battery powers the device. The StatStrip Glucose Hospital Meter Test Strips are designed with an electrode that measures Glucose levels. Glucose in the blood sample mixes with reagent on the test strip that produces an electric current. The amount of current that is produced depends on how much Glucose is in the blood. The strip is designed such that when a drop of blood is touched to the end of the strip, the blood is drawn into the reaction space via capillary action.

The StatStrip Xpress 2 Glucose Hospital Meter System is intended for point-of-care, in vitro diagnostic, multiple-patient use for the quantitative determination of glucose in capillary finger stick, venous whole blood, arterial whole blood, neonate arterial whole blood and neonate heel stick specimens. The StatStrip Xpress 2 Glucose Hospital Meter System is also intended for use in the quantitative determination of glucose in venous whole blood, arterial whole blood, neonatal heel stick and neonatal arterial samples throughout all hospital and all professional healthcare settings. The system should only be used with single-use, auto-disabling lancing devices when performing a capillary finger stick or neonate heel stick. lt is not intended for use with neonate cord blood specimens. It is not intended for the screening or diagnosis of diabetes mellitus but is indicated for use in determining dysglycemia.

The StatStrip Xpress Glucose Hospital Meter System previously cleared under K070960 and K150461 is being modified to include a 2.2 inch color graphics display and an updated ergonomic design. The new system will be sold as the StatStrip Xpress 2 Glucose Hospital Meter System. The intended use of the modified StatStrip Xpress 2 Glucose Hospital Meter System has not changed as a result of the modifications. The StatStrip Xpress 2 Glucose Hospital Meter utilizes a 2.2" color graphics display in place of the segmented display that is currently used in the predicate StatStrip Xpress Glucose Hospital Meter. The color screen allows for the user interface to be displayed in a more modern format; however the overall screen content of the meter will remain unchanged from the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter will utilize the same screen progressions and user workflow as the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same three button keypad design as the predicate to navigate the user interface. To support the increased power requirements of the color display, the newly designed StatStrip Xpress 2 Glucose Hospital Meter will be powered by two AAA batteries in place of the single Li 2450 coin cell battery used in the predicate StatStrip Xpress Glucose Hospital Meter. The StatStrip Xpress 2 Glucose Hospital Meter uses identical signal processing and results generating methods and stores test results in the same manner as the predicate device. The StatStrip Xpress 2 Glucose Hospital Meter's new ergonomic design introduces a flat, top surface design that eliminates ridges, recessed corners and raised edges. The strip port has been moved to the bottom of StatStrip Xpress 2 Glucose Hospital Meter in order to increase customer satisfaction. The new location of the strip port reduces the chance of control material entering the strip port. The StatStrip Xpress 2 Glucose Hospital Meter utilizes the same strip port and electronics for making glucose measurements as the predicate device. The proposed device has the same performance characteristics as the predicate device.