Abstract: Embodiments provide apparatus, systems, and methods adapted to communicate analyte data and/or related information. In a first aspect, the apparatus includes a transmitter/receiver unit which is configurable as either a transmitter or a receiver. The transmitter/receiver unit may be coupled to an on-body sensor and may be configured as a transmitter, or may be coupled to a management unit and may be configured as a receiver as part of a continuous analyte monitoring system. Analyte data communication systems and methods are provided, as are other aspects.

Abstract: A method and apparatus implements patient data downloading for multiple different meter types, such as multiple different blood glucose meters. A plurality of serial ports is provided, each arranged for connection to a respective meter of the multiple different meter types. Information is displayed and user selections are identified. Responsive to user entry identifying a particular meter type, a connection port/cable number for the meter connection is displayed for viewing by the user. Predefined instructions for the particular meter type are displayed. A data collection computer system is provided as an integral unit including a unitary housing containing a processor device, a printer, and a display touch screen. When a meter connection is identified, information is displayed, patient data is downloaded from the meter and is printed in a selected format together with selected reports generated from the downloaded patient data.

Abstract: An electrochemical sensor system comprises an electrochemical sensor and a hydrogel composition. The electrochemical sensor has at least a counter electrode and a working electrode. The hydrogel composition contacts the working electrode. The hydrogel composition comprises a first monomer, a second monomer, a cross-linking agent, and a solvent. The first monomer has hydrophilic characteristics. The second monomer has hydrophobic characteristics. The ratio of the first monomer to the second monomer is from about 0.1:99.9 to about 99.9:0.1.

Abstract: A biosensor system determines an analyte concentration of a biological sample using an electrochemical process without Cottrell decay. The biosensor system generates an output signal having a transient decay, where the output signal is not inversely proportional to the square root of the time. The transient decay is greater or less than the ?0.5 decay constant of a Cottrell decay. The transient decay may result from a relatively short incubation period, relatively small sample reservoir volumes, relatively small distances between electrode surfaces and the lid of the sensor strip, and/or relatively short excitations in relation to the average initial thickness of the reagent layer. The biosensor system determines the analyte concentration from the output signal having a transient decay.

Abstract: An electrochemical test sensor is adapted to measure glucose and correct for the oxygen effect in a fluid sample. The test sensor comprises a base, first and second working electrodes, and a counter electrode. The first working electrode includes glucose oxidase, a mediator and peroxidase. The second working electrode includes glucose oxidase and the mediator. The first working electrode, the second working electrode and the counter electrode are located on the base. In other embodiments, an electrochemical test sensor is adapted to measure cholesterol, lactate, pyruvate or xanthine and correct for the oxygen effect in a fluid sample.

Abstract: A biosensor system including the underfill management system determines the analyte concentration in a sample from the at least one analytic output signal value. The underfill management system includes an underfill recognition system and an underfill compensation system. The underfill recognition system determines whether the test sensor initially is substantially full-filled or underfilled, indicates when the sample volume is underfilled so that additional sample may be added to the test sensor, and starts or stops the sample analysis in response to the sample volume. The underfill recognition system also may determine the initial degree of underfill. After the underfill recognition system determines the initial fill state of the test sensor, the underfill compensation system compensates the analysis based on the initial fill state of the test sensor to improve the measurement performance of the biosensor system for initially underfilled test sensors.

Abstract: An architecture allows individual system components to be developed and tested individually, i.e., as distinct modules, and to be subsequently combined through standardized electrical and communication interfaces. Any combination of these modules can be implemented to form different products that provide any number of functions, such as an integrated system for monitoring a health condition and/or delivering a medication. The architecture also provides an approach for dynamically updating the product and offering its users the latest generation of technology even after the users have already purchased the product. In particular, the embodiments employ the communication interfaces to also provide connection to a remote network that can update or upgrade the product's software when the product is out in the field.

Abstract: A system and method for rapidly determining ambient temperature in a fluid-analyte meter. The meter includes a housing defining an interior space and an area for receiving a fluid sample. A processor and a first temperature sensor are disposed within the interior space of said the housing. A second temperature sensor is disposed on the housing. One or more processors are configured to determine a first temperature value from temperature data received from the first temperature sensor. The processor(s) are also configured to apply a variable current to a temperature-adjustment source such that the second temperature sensor is adjusted to a predetermined steady-state temperature value different from the first temperature value. The processor(s) are further configured to determine an ambient temperature of an exterior space of the housing based on the applied variable current, pre-determined steady-state temperature, and received first temperature values.

Abstract: Embodiments of the invention provide apparatus, systems, and methods wherein pre-event and post-event analyte concentration readings associated with an event are collected and processed to determine a numerical delta. The numerical delta may be displayed on a visual display to aid in a ready determination of the affect that the event (alone or in combination with medication and/or insulin dosages) had on the analyte concentration levels. Medication and/or insulin dosages may be displayed alongside the numerical delta to gauge immediate relationships between numerical delta, dosage, and/or an associated event. Apparatus and systems for calculating and displaying the numerical delta are described, as are other aspects.

Abstract: A reagent composition for a biosensor sensor strip is disclosed that provides for rapid rehydration after drying. The composition includes porous particles and is preferably formed as a colloidal suspension. The dried reagent composition including porous particles may provide analytically useful output from the sensor strip in a shorter time period than observed from dried reagent compositions using solid particles. The output signal from the porous particle compositions may be correlated to the analyte concentration of a sample within about two seconds. In this manner, an accurate concentration determination of an analyte concentration in a sample may be obtained in less time than from sensor strips including conventional compositions. The reagent composition including the porous particles also may allow for the redox reaction between the reagents and the analyte to reach a maximum kinetic performance in a shorter time period than observed from conventional sensor strips.

Abstract: Some embodiments of the present invention include pairing two wireless devices by placing at least one of two devices in a pairing mode; performing at least one pairing motion event with at least one of the wireless devices to satisfy at least one pairing condition; detecting satisfaction of the at least one pairing condition; and pairing the two wireless devices in response to detecting satisfaction of the at least one pairing condition. Numerous other aspects are provided.

Abstract: An analyte meter to detect an analyte concentration level in a bio-fluid sample may be cleaned and disinfected with a cleaning liquid without harming electrical and internal meter components. In some embodiments, the analyte meter is washable and immersable and may include a sealed sensor connector, sealed battery connector, and possibly a sealed USB connector that may be subjected to a cleaning liquid without the liquid entering an internal chamber of the analyte meter and contacting internal electronic components. In some embodiments, a sealed display screen and sealed keypad are provided such that liquids are prevented from entering the internal chamber. Manufacturing methods and systems utilizing the analyte sensors are provided, as are numerous other aspects.

Abstract: A blood glucose monitor includes a can, a replaceable sensor cartridge that includes a frame, an upper spring disposed between the frame and the can, a case for housing the can and sealing the frame, a lower spring disposed between the can and the case, and a meter housing for sealing an upper portion of the frame. The can is capable of accepting the replaceable sensor cartridge. The frame of the removable cartridge has at least at least two walls defining a chamber for accepting a plurality of biosensors, and a bottom portion defining an opening and at least one sealing flange. The frame can further include a desiccant material capable of reducing humidity within the frame. The frame may be dimensioned such that an interference fit constrains the plurality of biosensors prior to inserting the frame within a blood glucose monitor.

Abstract: A biosensor (102) for determining the presence or amount of a substance in a sample and methods of use of the biosensor (102) are provided. The biosensor (102) for receiving a user sample to be analyzed includes a mixture for electrochemical reaction with an analyte. The mixture includes an enzyme, a mediator and an oxidizable species as an internal reference.

Abstract: Systems and methods for detecting dried test strips are provided, where a dried test strip may be one that has been re-inoculated with a biological sample after having already been previously inoculated with another sample at an earlier time (e.g., hours or days before). In various aspects, a biosensor such as an amperometric glucose biosensor (“meter”) may apply one or more input electrical signals to an inoculated test strip having at least a pair of electrodes in contact with the biological sample. The meter may measure output current value(s) resulting in response to the input electrical signals applied to the test strip. The meter may determine whether the test strip is a dried test strip by comparing a ratio of the measured output current value(s) with a boundary ratio value.

Abstract: A microdeposition pin having a contact surface with at least one concave edge for creating microarrays and the like. The microdeposition pin may be used either alone or with a plurality of microdeposition pins in conjunction with a holder. The concave edge of the pin is especially adapted for helping to control the spreading of a deposited material. By selectively controlling the spread of the reagent composition from the microdeposition pin, the flow of the reagent composition from the deposition target area may be reduced. Sensor strips having raised substrate features with limited or no spreading of the reagent composition beyond the target area are disclosed.

Abstract: A system and method is described for rapid charging and power management of a battery for a meter. A charger component is operably associated with the meter and is capable of executing a rapid charge algorithm for a rechargeable battery. The algorithm includes monitoring for a connection to an external power source and implementing a charging routine of a battery at a first charge rate and then at a second charge rate. The second charge rate is lower than the first charge rate. A temperature rise in the rechargeable battery due to the first charge rate has a negligible heat transfer effect on the fluid sample. The meter can also include a power switch for controlling current flow to a battery fuel gauge. The power switch is open when the meter enters into a sleep mode. The state of battery charge is determined after the meter exits the sleep mode.

Abstract: In some aspects, an analyte sensor is provided for detecting an analyte concentration level in a bio-fluid sample. The analyte sensor may include one or more conductors received in a hollow portion of a hollow member. The first conductor may be made, at least in part, of a semiconductor material and an active region may be provided in contact with at least the first conductor. The analyte sensor may, in one aspect, include a lancet and an integrated sensor. Manufacturing methods and apparatus and systems utilizing the analyte sensors are provided, as are numerous other aspects.

Abstract: An electrochemical sensor system is adapted to assist in determining an analyte concentration of a fluid. The electrochemical sensor system comprises a substrate, conductive material and a hydrogel or liquid. The substrate having porosity therethrough. The conductive material includes at least one electrode. The at least one electrode is coupled to the substrate. The at least one electrode has a first surface and an opposing second surface. The hydrogel or liquid is adapted to assist in carrying the analyte of the fluid to the first and second surfaces of the at least one electrode.

Abstract: A multi-layer pad that is adapted to be used in determining an analyte concentration is disclosed. The multi-layer pad includes a first layer, a second layer, and a third layer. The first layer includes an enzyme wherein the enzyme is adapted to assist in determining the analyte concentration. The second layer is attached to a first surface of the first layer. The second layer is made of a skin-conforming material. The third layer is attached to a second surface of the first layer wherein the first layer is located between the second layer and the third layer. It is contemplated that the multi-layer pad may also be a two layer system.