Abstract: A wearable apparatus for maintaining microneedles or other types of skin penetrating projections in contact with the interstitial fluid of the skin is disclosed. The apparatus has a skin contacting portion and a movable portion bearing the microneedles. The microneedles are initially in a retracted state, and are urged into the skin by movement of the movable portion along a non-linear, or arcuate path. The apparatus has a low profile when retained on the skin and is therefore less intrusive for extended wear applications such as continuous analyte monitoring and slow release drug delivery.

Abstract: Disclosed herein are methods and devices for detecting the presence of an analyte of interest. A biosensor device can include a reaction chamber and an electrochemical detection chamber. The reaction chamber can include at least one immobilized binding site and a probe conjugate adapted to bind to at least one of the target analyte and the immobilized binding site while the detection chamber can include electrodes for detecting an electrochemical reaction. If present, the target analyte in the fluid sample results in a change in the amount of probe conjugate bound in the reaction chamber, which can be detected electrochemically in the detection chamber.

Abstract: Devices and methods are provided for determining the concentration of a reduced form of a redox species. For example, a device can include a working electrode and a counter electrode spaced by a predetermined distance so that reaction produces from the counter electrode arrive at the working electrode. An electric potential difference can be applied between the electrodes, and the potential of the working electrode can be selected such that the rate of electro-oxidation of the reduced form of the species is diffusion controlled. Current as a function of time can be determined, the magnitude of the steady state current can be estimated, and a value indicative of the diffusion coefficient and/or of the concentration of the reduced form of the species can be obtained from the change in current with time and the magnitude of the steady state current. Other embodiments of apparatuses, devices, and methods are also provided.

Abstract: Methods of determining a corrected analyte concentration in view of some error source are provided herein. The methods can be utilized for the determination of various analytes and/or various sources of error. In one example, the method can be configured to determine a corrected glucose concentration in view of an extreme level of hematocrit found within the sample. In other embodiments, methods are provided for identifying various system errors and/or defects. For example, such errors can include partial-fill or double-fill situations, high track resistance, and/or sample leakage. Systems are also provided for determining a corrected analyte concentration and/or detecting some system error.

Abstract: Methods of determining a corrected analyte concentration in view of some error source are provided herein. The methods can be utilized for the determination of various analytes and/or various sources of error. In one example, the method can be configured to determine a corrected glucose concentration in view of an extreme level of hematocrit found within the sample. In other embodiments, methods are provided for identifying various system errors and/or defects. For example, such errors can include partial-fill or double-fill situations, high track resistance, and/or sample leakage. Systems are also provided for determining a corrected analyte concentration and/or detecting some system error.

Abstract: Devices and methods are provided for determining the concentration of a reduced form of a redox species. For example, a device can include a working electrode and a counter electrode spaced by a predetermined distance so that reaction produces from the counter electrode arrive at the working electrode. An electric potential difference can be applied between the electrodes, and the potential of the working electrode can be selected such that the rate of electro-oxidation of the reduced form of the species is diffusion controlled. Current as a function of time can be determined, the magnitude of the steady state current can be estimated, and a value indicative of the diffusion coefficient and/or of the concentration of the reduced form of the species can be obtained from the change in current with time and the magnitude of the steady state current. Other embodiments of apparatuses, devices, and methods are also provided.

Abstract: Devices and methods are provided for determining the concentration of a reduced form of a redox species. For example, a device can include a working electrode and a counter electrode spaced by a predetermined distance so that reaction produces from the counter electrode arrive at the working electrode. An electric potential difference can be applied between the electrodes, and the potential of the working electrode can be selected such that the rate of electro-oxidation of the reduced form of the species is diffusion controlled. Current as a function of time can be determined, the magnitude of the steady state current can be estimated, and a value indicative of the diffusion coefficient and/or of the concentration of the reduced form of the species can be obtained from the change in current with time and the magnitude of the steady state current. Other embodiments of apparatuses, devices, and methods are also provided.

Abstract: Described herein are systems and methods for distinguishing between a control solution and a blood sample. In one aspect, the methods include using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or a control solution based on at least two characteristics. Further described herein are methods for calculating a discrimination criteria based upon at least two characteristics. Still further described herein are system for distinguishing between blood samples and control solutions.

Abstract: Devices and methods are provided for determining the concentration of a reduced form of a redox species. For example, a device can include a working electrode and a counter electrode spaced by a predetermined distance so that reaction produces from the counter electrode arrive at the working electrode. An electric potential difference can be applied between the electrodes, and the potential of the working electrode can be selected such that the rate of electro-oxidation of the reduced form of the species is diffusion controlled. Current as a function of time can be determined, the magnitude of the steady state current can be estimated, and a value indicative of the diffusion coefficient and/or of the concentration of the reduced form of the species can be obtained from the change in current with time and the magnitude of the steady state current. Other embodiments of apparatuses, devices, and methods are also provided.

Abstract: A microfluidic device for transferring liquid from a first chamber to a second chamber is provided. The device has a first chamber; a second chamber; and a barrier between the first chamber and the second chamber, the barrier having least one opening fluidly connecting the first chamber to the second chamber, the at least one opening being sized such that a retention force, such as surface tension, keeps the liquid in the first chamber. The fluid is transferred from the first chamber to the second chamber when an initiation input such as fluid pressure is introduced to the liquid that is sufficient to overcome the retention force. The device may be a sensor strip.

Abstract: Disclosed herein are methods and apparatus for determining analyte concentration in a rapid and accurate manner. The methods include depositing a physiological sample in an electrochemical cell and finding a first and second current transient. Peak current values are obtained from the first and second peak current values and used to reduce the influence of interferents in a current value. Based on this “corrected” current value, an accurate analyte concentration can be determined.

Abstract: A hollow electrochemical cell is provided. In one exemplary embodiment, a hollow electrochemical cell includes two sets of electrodes and an opening for admitting an analyte to the cell. At least one of the two sets of electrodes can be in fluid communication with the opening. Further, a first set of electrodes can include a working electrode spaced from a counter or counter/reference electrode by less than 500 ?m one embodiment the working and counter or counter/reference electrodes are not co-planer. In another embodiment the working and counter or counter/reference electrodes are of substantially corresponding area. In yet another embodiment the working and counter or counter/reference electrodes are spaced from 100 to 200 ?m apart. The first set of electrodes and the second set of electrodes can be spaced apart by greater than about 500 ?m. Other embodiments of a hollow electrochemical cell are also provided, as are several embodiments of a glucose sensor.

Abstract: A method for determining the concentration of a reduced or oxidized form of a redox species is provided. In one exemplary embodiment, an electrochemical apparatus is provided in which the apparatus includes a hollow electrochemical cell for measuring a concentration of glucose in a blood sample, a current of the cell is measured, and a concentration of a redox mediator is determined, at least in part from, a measured current of the cell. The hollow electrochemical cell can include at least one non-metal working electrode, at least one counter electrode or counter/reference electrode, and a spacer interposed between the working electrode and the counter or counter/reference electrode. In one embodiment the working electrode and the counter or counter/reference electrode are not co-planer and are separated by a distance of from about 20 microns to about 200 microns.

Abstract: Described herein are systems and methods for distinguishing between a control solution and a blood sample. In one aspect, the methods include using a test strip in which multiple current transients are measured by a meter electrically connected to an electrochemical test strip. The current transients are used to determine if a sample is a blood sample or a control solution based on at least two characteristics. Further described herein are methods for calculating a discrimination criteria based upon at least two characteristics. Still further described herein are system for distinguishing between blood samples and control solutions.

Abstract: An electromagnetic radiation collector is provided. The electromagnetic radiation collector has a concentration chamber for collecting and concentrating electromagnetic radiation and directing it to a target, the concentration chamber having at least one inlet opening, the inlet opening having a cross-sectional area. The collector also has a channeling area having an entry end for receiving the electromagnetic radiation, the entry end having a cross-sectional area, an exit end adjacent to the inlet opening of the concentration chamber, and at least one reflective wall between the entry end and the exit end. The cross-sectional area of the inlet opening is smaller than the cross-sectional area of the entry end of the channeling area.

Abstract: A method of manufacture of an electrochemical cell is provided. In one exemplary embodiment, at least one non-metal working electrode is provided, at least one counter electrode or counter/reference electrode is provided such that it is not co-planer with respect to the working electrode, and a spacer is provided interposed between the working and counter or counter/referenced electrode. In one embodiment the counter or counter/reference electrode can be separated from the working electrode by a distance of from about 20 microns to about 200 microns. Alternatively, the cell can have an effective volume of less than 1.5 microliters. A method of manufacture of an electrochemical apparatus is also provided. The method can include providing both a hollow electrochemical cell for measuring a concentration of glucose in a blood sample and a mechanism configured to determine a concentration of a redox mediator from, at least in part, a measured current of the cell.

Abstract: A method for determining the concentration of a reduced or oxidized form of a redox species is provided. In one exemplary embodiment, an electrochemical apparatus is provided in which the apparatus includes a hollow electrochemical cell for measuring a concentration of glucose in a blood sample, a current of the cell is measured, and a concentration of a redox mediator is determined, at least in part from, a measured current of the cell. The hollow electrochemical cell can include at least one non-metal working electrode, at least one counter electrode or counter/reference electrode, and a spacer interposed between the working electrode and the counter or counter/reference electrode. In one embodiment the working electrode and the counter or counter/reference electrode are not co-planer and are separated by a distance of from about 20 microns to about 200 microns.

Abstract: A hollow electrochemical cell is provided. In one exemplary embodiment, a hollow electrochemical cell includes two sets of electrodes and an opening for admitting an analyte to the cell. At least one of the two sets of electrodes can be in fluid communication with the opening. Further, a first set of electrodes can include a working electrode spaced from a counter or counter/reference electrode by less than 500 ?m. In one embodiment the working and counter or counter/reference electrodes are not co-planer. In another embodiment the working and counter or counter/reference electrodes are of substantially corresponding area. In yet another embodiment the working and counter or counter/reference electrodes are spaced from 100 to 200 ?m apart. The first set of electrodes and the second set of electrodes can be spaced apart by greater than about 500 ?m. Other embodiments of a hollow electrochemical cell are also provided, as are several embodiments of a glucose sensor.

Abstract: Disclosed herein are methods and devices for detecting the presence of an analyte of interest. A biosensor device can include a reaction chamber and an electrochemical detection chamber. The reaction chamber can include at least one immobilized binding site and a probe conjugate adapted to bind to at least one of the target analyte and the immobilized binding site while the detection chamber can include electrodes for detecting an electrochemical reaction. If present, the target analyte in the fluid sample results in a change in the amount of probe conjugate bound in the reaction chamber, which can be detected electrochemically in the detection chamber.

Abstract: A microfluidic device for transferring liquid from a first chamber to a second chamber is provided. The device has a first chamber; a second chamber; and a barrier between the first chamber and the second chamber, the barrier having least one opening fluidly connecting the first chamber to the second chamber, the at least one opening being sized such that a retention force, such as surface tension, keeps the liquid in the first chamber. The fluid is transferred from the first chamber to the second chamber when an initiation input such as fluid pressure is introduced to the liquid that is sufficient to overcome the retention force. The device may be a sensor strip.