Abstract: A lancing device with automatic stick and lance return features is disclosed. A drive mechanism within the unit comprises a slider-crank linkage combination. It is biased by a spring member to cause automatic firing once a crank member advanced by a user causes movement of an internal linkage member beyond its fully-cocked position. After firing, the lance is withdrawn so as not to pose a threat of secondary injury to the user. In use, the device is substantially silent though its course of operation. Yet, its configuration lends itself to producing a very quick, virtually painless stick with minimal recoil or shock to the device.

Abstract: Methods and devices for determining the concentration of an analyte in a physiological sample are provided. In the subject methods, the physiological sample is introduced into an electrochemical cell having a working and reference electrode. A first electric potential is applied to the cell and the resultant cell current over a period of time is measured to determine a first time-current transient. A second electric potential of opposite polarity is then applied and a second a time-current transient is determined. The preliminary concentration of the analyte is then calculated from the first and/or second time-current transient. This preliminary analyte concentration less a background value is then multiplied by a hematocrit correction factor to obtain the analyte concentration in the sample, where the hematocrit correction factor is a function of the preliminary analyte concentration and the variable ? of the electrochemical cell.

Abstract: This invention relates to a biosensor and more particularly to an electrochemical biosensor for determining the concentration of an analyte in a carrier. The invention is particularly useful for determining the concentration of glucose in blood and is described herein with reference to that use but it should be understood that the invention is applicable to other analytic determinations.

Abstract: Devices, systems, methods and kits are provided for use in determining the concentration of chemical and biochemical components in aqueous fluids. The subject devices include test strips which define a longitudinal axis and include a distal edge configured for insertion into a measurement instrument and having an alignment notch formed in the distal edge for engagement with an alignment member of the measurement instrument. The alignment notch has opposing edges wherein at least a portion of the opposing edges is in substantially parallel relation to the longitudinal axis. In using the subject devices, the devices are inserted into a measurement instrument having an alignment pin. When operatively engaged with the alignment pin, the notch serves to maintain the device in a substantially motionless position. The invention is useful in a variety of applications, particularly in the determination of blood glucose concentrations.

Abstract: Electrochemical test strip cards that can be singulated to produce electrochemical test strips are provided. The electrochemical test cards are made up of two or more electrochemical test strip precursors, where each precursor is characterized by the presence of a dry reagent housing reaction chamber bounded by opposing electrodes. In gaseous communication with each reaction chamber of the card is an integrated desiccant. Also provided are methods of using the subject electrochemical test strips cards, as well as kits that include the same. The subject test strips and cards find use in the detection/concentration determination of a number of different analytes, including glucose.

Abstract: A medical diagnostic device for measuring an analyte concentration or property of a biological fluid includes capillary flow channels to convey a sample of the fluid from an inlet to a branching point, and then to a measurement area and, alternatively, through a bypass channel to an overflow region. A first stop junction stops fluid flow after it enters the measurement area. The bypass channel has a capillary dimension in at least one direction. A second stop junction, in the bypass channel, has boundary region that has a dimension that is greater in that direction and forms an angle that points toward the branching point. With this construction, the second stop junction initially prevents flow to the overflow region, but permits the flow after the measurement area is filled. The device is particularly suited for measuring coagulation time of blood.

Abstract: The invention provides a substantially moisture-proof, air-tight apparatus for both dispensing a plurality of diagnostic test strips and testing a biological fluid dispensed onto the strip. One strip may be advanced for use in testing using a single, translational movement.

Abstract: This invention relates to a biosensor and more particularly to an electrochemical biosensor for determining the concentration of an analyte in a carrier. The invention is particularly useful for determining the concentration of glucose in blood and is described herein with reference to that use but it should be understood that the invention is applicable to other analytic determinations.

Abstract: Methods and devices for determining the concentration of an analyte in a physiological sample are provided which correct for errors in the analyte concentration measurement which are due to the hematocrit of the sample.

Abstract: The present invention includes devices, systems and methods for containing and using liquid solutions. The devices include liquid containment structures and packages of such liquid containment structures for containing single doses of a liquid solution for subsequent use. The systems include at least one subject containment structure or package of containment structures and the liquid solution for which they are intended to contain. The liquid solutions may comprise any type of agent, reagent or control solution. The subject methods involve the use of the liquid containment structures and packages thereof as well as methods of providing a control solution for use to evaluate a system's performance.

Abstract: Test strips for determining the concentration of at least one analyte, e.g., glucose, in a physiological sample and methods for their manufacture and use and are provided. The subject test strips include a transfer element for facilitating the transfer of sample to a reaction area of the test strip. In certain embodiments, the transfer element, typically porous, has a first area and a second area, and in certain embodiments the two areas have different thicknesses. In other embodiments, the transfer element is non-porous and is configured to transfer sample by wicking it between the transfer element and the reaction area of the test strip. In the subject methods, the transport element facilitates transfers of a sample to a reaction area of the test strip. The subject test strips and methods find use in a variety of different applications, particularly in the determination of glucose concentrations.

Abstract: Devices and methods for determining the concentration of an analyte in a physiological sample are provided. The subject devices are meters characterized by having an internal structure that includes a test strip selecting element having a continuously reduced cross-sectional area configured to select a single test strip at a time and means for determining the concentration of an analyte in a physiological sample applied to the selected test strip. In the subject methods for containing at least one test strip and dispensing a single test strip at a time, a meter having at least one test strip contained therein is provided. The meter is positioned with respect to the ground to cause the single test strip to move from a contained position to a dispensed position. The subject invention also includes kits for use in practicing the subject methods.

Abstract: This invention relates to a biosensor and more particularly to an electrochemical biosensor for determining the concentration of an analyte in a carrier. The invention is particularly useful for determining the concentration of glucose in blood and is described herein with reference to that use but it should be understood that the invention is applicable to other analytic determinations.

Abstract: The invention provides a method for determining the concentration of an analyte in a sample comprising the steps of heating the sample and measuring the concentration of the analyte or the concentration of a species representative thereof in the sample at a predetermined point on a reaction profile by means that are substantially independent of temperature. Also provided is an electrochemical cell comprising a spacer pierced by an aperture which defines a cell wall, a first metal electrode on one side of the spacer extending over one side of the aperture, a second metal electrode on the other side of the spacer extending over the side of the aperture opposite the first electrode, means for admitting a sample to the cell volume defined between the electrodes and the cell wall, and means for heating a sample contained within the cell.

Abstract: A device for accessing biological fluid, sampling biological fluid constituents and determining the concentration of at least one target constituent within the accessed biological fluid is provided. The device has at least one micro-piercing member used to penetrate the skin to a selected depth and to access biological fluid, a constituent sampling means and a constituent measuring means. The constituent sampling means comprises a constituent transfer medium, such as a hydrophilic gel material, by which sampled constituents are transferred from the micro-piercing member to the measuring means. The measuring means includes an electrochemical cell having at least one porous electrode through which at least one sampled constituent is caused to enter into the electrochemical cell. Methods of sampling constituents within the skin and measuring the sampled constituents, as well as kits for practicing the invention are provided.

Abstract: Systems and methods are provided for determining whether a volume of biological sample is adequate to produce an accurate analyte concentration measurement. Certain such systems and methods provide the additional function of compensating for a sample volume determined to be less than adequate in order to proceed with an accurate analyte concentration measurement. The present invention is employed with a biosensor, such as an electrochemical test strip to which the sample volume of biological solution is deposited, and a meter configured to receive such test strip and to measure the concentration of selected analytes within the biological sample.

Abstract: Devices for dispensing test strips and methods of using the same are provided. The subject devices are characterized by having a housing made of a cover and a base configured to retain a plurality of test strips. In certain embodiments, the height of the base is less than the height of each of the test strips, such that a portion of each of the test strips extends beyond the distal or top edge of the base. The subject devices may further be characterized as having a substantially air and moisture tight seal. In using the subject devices, a plurality of test strips stored in a subject device are provided. A single test strip is removed from the subject device by moving the test strip distal to the remaining test strips. Also provided by the subject invention are kits for use in practicing the subject methods.

Abstract: The present invention provides methods and systems for passively and automatically detecting the presence of a sample (the “sample detection phase”) upon application of the sample to a biosensor, identifying the sample detection time and then initiating the measurement of a targeted characteristic, e.g., the concentration of one or more analytes, of the sample (the “measurement phase”), immediately upon sample detection. The subject methods and systems do not employ or involve the application of an electrical signal from an external source to the electrochemical cell for purposes of performing the sample detection phase and are, thus, less complicated and involve fewer steps and components.

Abstract: Gimbaled bladder actuators and methods for their use in compressing bladders present on test strips are provided. The subject actuators are characterized by the presence of a gimbaled compression pad under movement control of an actuating means, preferably an automated actuating means. Also provided are meters for reading test strips that include bladders, where the meters include the subject gimbaled bladder actuators.

Abstract: A biosensor for use in determining a concentration of a component in an aqueous liquid sample is provided including: an electrochemical cell having a first electrically resistive substrate having a thin layer of electrically conductive material, a second electrically resistive substrate having a thin layer of electrically conductive material, the substrates being disposed with the electrically conductive materials facing each other and being separated by a sheet including an aperture, the wall of which aperture defines a cell wall and a sample introduction aperture whereby the aqueous liquid sample may be introduced into the cell; and a measuring circuit.