Abstract: Analyte sensors and methods for fabricating analyte sensors in a roll-to-roll process are provided. In an exemplary embodiment, a method includes providing a roll of a polyester substrate having a first side coated with a layer of platinum, wherein the platinum is in direct contact with the polyester substrate; patterning the layer of platinum to form electrodes; punching the polyester substrate to form ribbons, wherein each ribbon is connected to a remaining polyester substrate web by a tab, and wherein each sensor includes an electrode; after punching the polyester substrate to form ribbons, depositing an enzyme layer over the portions of the working electrodes and coating the working electrodes with a glucose limiting membrane; after depositing the enzyme layer over the portions of the working electrodes and coating the working electrodes with a glucose limiting membrane, singulating the individual sensors by completely separating each individual sensor from the polyester substrate.

Abstract: Analyte sensors and methods for fabricating analyte sensors are provided. In an exemplary embodiment, a method for fabricating a planar flexible analyte sensor includes sputtering platinum onto a polyester base layer to form a layer of platinum. The method includes patterning the layer of platinum to form working electrodes and additional electrodes. Further, the method includes forming an insulating dielectric layer over the base layer, wherein the insulating dielectric layer is formed with openings exposing portions of the working electrodes and portions of the additional electrodes. Also, the method includes partially singulating individual sensors from the base layer, wherein each individual sensor is connected to the base layer by a tab. The method further includes depositing an enzyme layer over the exposed portions of the working electrodes and coating the working electrodes with a glucose limiting membrane.

Abstract: Embodiments provide a sensor insertion tool (SIT) that provides a motive force for insertion of an analyte sensor into/through skin. A SIT may be releasably locked to one or more components of a sensor insertion system, such that components of the sensor insertion system remain securely coupled during sensor insertion. A SIT may include a release member that unlocks or uncouples the SIT and the other components after sensor insertion. In various embodiments, a SIT may be a component of a sensor insertion system configured for assembly by an end user, a health care professional, and/or a caretaker prior to sensor insertion, and may act in cooperation with other sensor insertion system components. Additional components and methods of assembly and use are also provided herein.

Abstract: Embodiments provide a sensor insertion tool (SIT) that provides a motive force for insertion of an analyte sensor into/through skin. A SIT may be releasably locked to one or more components of a sensor insertion system, such that components of the sensor insertion system remain securely coupled during sensor insertion. A SIT may include a release member that unlocks or uncouples the SIT and the other components after sensor insertion. In various embodiments, a SIT may be a component of a sensor insertion system configured for assembly by an end user, a health care professional, and/or a caretaker prior to sensor insertion, and may act in cooperation with other sensor insertion system components. Additional components and methods of assembly and use are also provided herein.

Abstract: Analyte sensors and methods for fabricating analyte sensors are provided. In an exemplary embodiment, a planar flexible analyte sensor includes a flexible base layer and a first electrode formed from a layer of sputtered platinum on the base layer. Also, the analyte sensor includes an insulating dielectric layer over the base layer, wherein the insulating dielectric layer leaves a portion of the first electrode exposed. Further, the analyte sensor includes an electrochemical sensing stack over the exposed portion of the first electrode, including a glucose oxidase layer over the layer of sputtered platinum and a glucose limiting membrane over the glucose oxidase layer.

Abstract: Analyte sensors and methods for fabricating analyte sensors are provided. In an exemplary embodiment, a method for fabricating a planar flexible analyte sensor includes sputtering platinum onto a polyester base layer to form a layer of platinum. The method includes patterning the layer of platinum to form working electrodes and additional electrodes. Further, the method includes forming an insulating dielectric layer over the base layer, wherein the insulating dielectric layer is formed with openings exposing portions of the working electrodes and portions of the additional electrodes. Also, the method includes partially singulating individual sensors from the base layer, wherein each individual sensor is connected to the base layer by a tab. The method further includes depositing an enzyme layer over the exposed portions of the working electrodes and coating the working electrodes with a glucose limiting membrane.

Abstract: Methods and devices for determining the concentration of a constituent in a physiological sample are provided. The blood sample is introduced into a test strip with portions of the blood sample being directed to both a first capillary and a second capillary. The first capillary configured to electrochemically determine a concentration of a first analyte in a blood sample by measuring a signal across a set of electrodes. The second capillary is configured to determine a hematocrit value of the blood sample by measuring a signal across a second set of electrodes.

Abstract: Embodiments herein provide an analyte sensor subassembly that provides an integrated structure enabling suitably secure electrical contact between an analyte sensor and the electronic components of an analyte sensor assembly. An analyte sensor subassembly assists the process of inserting the sensor into skin. An analyte sensor subassembly may operate in concert with one or more sensor insertion tools to provide insertion of an analyte sensor into the skin of a subject/patient. Associated devices, such as channel guides and sensor insertion tools, are also provided, as are methods of operation and sensor insertion.

Abstract: Methods and devices for determining the concentration of a constituent in a physiological sample are provided. The blood sample is introduced into a test strip with portions of the blood sample being directed to both a first capillary and a second capillary. The first capillary configured to electrochemically determine a concentration of a first analyte in a blood sample by measuring a signal across a set of electrodes. The second capillary is configured to determine a hematocrit value of the blood sample by measuring a signal across a second set of electrodes.

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: 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: Embodiments provide a sensor insertion tool (SIT) that provides a motive force for insertion of an analyte sensor into/through skin. A SIT may be releasably locked to one or more components of a sensor insertion system, such that components of the sensor insertion system remain securely coupled during sensor insertion. A SIT may include a release member that unlocks or uncouples the SIT and the other components after sensor insertion. In various embodiments, a SIT may be a component of a sensor insertion system configured for assembly by an end user, a health care professional, and/or a caretaker prior to sensor insertion, and may act in cooperation with other sensor insertion system components. Additional components and methods of assembly and use are also provided herein.

Abstract: Embodiments herein provide an analyte sensor subassembly that provides an integrated structure enabling suitably secure electrical contact between an analyte sensor and the electronic components of an analyte sensor assembly. An analyte sensor subassembly assists the process of inserting the sensor into skin. An analyte sensor subassembly may operate in concert with one or more sensor insertion tools to provide insertion of an analyte sensor into the skin of a subject/patient. Associated devices, such as channel guides and sensor insertion tools, are also provided, as are methods of operation and sensor insertion.

Abstract: Embodiments of the present invention provide an adhesive overbandage. In an embodiment, there is provided an adhesive overbandage for use with a biosensor. An exemplary overbandage comprises a frame having an upper surface, a lower surface, an outer boundary and an inner boundary, wherein the inner boundary defines an interior opening configured to receive a monitoring device, adhesive disposed on the lower surface of the frame, and a release liner removably coupled to the adhesive.

Abstract: Methods and devices for determining the concentration of a constituent in a physiological sample are provided. The blood sample is introduced into a test strip with portions of the blood sample being directed to both a first capillary and a second capillary. The first capillary configured to electrochemically determine a concentration of a first analyte in a blood sample by measuring a signal across a set of electrodes. The second capillary is configured to determine a hematocrit value of the blood sample by measuring a signal across a second set of electrodes.

Abstract: A diagnostic test strip is provided. The test strip comprises at least one electrically insulating substrate material and a plurality of electrical strip contacts disposed on the least one insulating substrate layer. The at least one electrical strip contact includes a first conductive layer disposed on the substrate, and a second conductive layer disposed on top of the first conductive layer.

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: 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: 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: 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.