Abstract: A method for manufacturing a biosensor is provided. The method may include positioning a shadow mask containing a pattern of a plurality of feature sets over a substantially planar base layer containing a plurality of registration points. The method may also include forming at least one of the plurality of feature sets on the substantially planar base layer by selectively depositing a layer of a conductive material on the substantially planar base layer by passing the conductive material through the pattern of the shadow mask and removing the shadow mask from the substantially planar base layer. Alternatively, the method may include providing a laminate structure including a substantially planar base layer containing a plurality of registration points and a photoresist layer containing a pattern of a plurality of feature sets.

Abstract: A biosensor having a first conductive component is described, wherein the first conductive component includes at least one boundary formed by a first processing technique and at least one boundary formed by a second processing technique not the same as the first processing technique. The biosensor can also have a second conductive component including at least one boundary formed by the first processing technique and at least one boundary formed by a third processing technique not the same as the first processing technique. Further, the biosensor has a third conductive component including at least one boundary formed by the second processing technique and at least one boundary formed by the third processing technique not the same as the second processing technique.

Abstract: The present disclosure relates to the manufacture of diagnostic test media used for measuring the concentration of analytes in a sample fluid. More specifically, the disclosure relates to using a method of microcontact printing or microtransfer molding for the manufacture of diagnostic test media.

Abstract: Methods and devices for automatically distinguishing between a control solution and an actual patient/user sample in a biosensor are provided. The solution is introduced into an electrochemical cell having a working and counter electrode. Electric pulses are applied to the cell and resultant signals are measured. Based on a comparison of the measured signals, a meter can determine whether the sample is a control solution or an actual patient/user sample.

Abstract: Disclosed herein is a biosensor for measuring analyte in a fluid that comprises a substrate layer having disposed thereon at least one each of an electrode, cathode, anode, and a novel spacer material. The spacer material according to the present disclosure comprises a heat sealable organic layer that covers at least a portion of the anode and defines at least one edge of the anode, wherein the spacer material has at least one hole punched through it and defines a cavity or well for accepting chemistry. Also disclosed is a method of making such biosensors.

Abstract: Methods and devices for determining the concentration of a constituent in a physiological sample are provided. The physiological sample is introduced into an electrochemical cell having a working and counter electrode. At least one electrochemical signal is measured based on a reaction taking place at the cell. The preliminary concentration of the constituent is then calculated from the electrochemical signal. This preliminary concentration is then multiplied by a hematocrit correction factor to obtain the constituent concentration in the sample, where the hematocrit correction factor is a function of the at least one electrochemical signal. The subject methods and devices are suited for use in the determination of a wide variety of analytes in a wide variety of samples, and are particularly suited for the determination of analytes in whole blood or derivatives thereof, where an analyte of particular interest is glucose.

Abstract: A method for manufacturing a test strip is provided. The method comprises selecting a test strip substrate material and positioning the test strip substrate material a predetermined distance from a matrix material disposed on a second substrate, wherein at least one enzyme to be deposited on the test strip substrate and having glucose as an enzymatic substrate is held within the matrix material. A laser pulse is directed towards the matrix material to release at least a portion of the at least one enzyme having glucose as an enzymatic substrate from the matrix material and deposit the enzyme on the test strip substrate.

Abstract: An auto-calibration system for diagnostic test strips is described for presenting data individually carried on each test strip readable by a diagnostic meter. The carried data may include an embedded code relating to data particular to that individual strip. The data is presented so at to be read by a meter associated with the diagnostic test strip in order to avoid manually inputting the information.

Abstract: A method of manufacturing a plurality of test strips is described where a web is formed containing conductive and base layers. A plurality of test strips are formed on the web by electrically isolating a first group of conductive components. Subsequently, a second group of conductive components are electrically isolated on the web by a different process. A test card for quality control analysis is also described, where the test card includes a plurality of attached test strip traces.

Abstract: Disclosed herein are biosensors for measuring analyte concentration in a bodily fluid comprising at least one electrode comprising semiconducting, conducting, or thin film carbon material, and an electron mediator comprising a ruthenium containing electron mediator, or a ferricyanide material or ferrocene carboxylic acid. Methods of measuring analyte concentration in a bodily fluid using such biosensors are also disclosed.