Abstract: An improved electrochemical sensor having a base bearing a working and counter electrode which provides a flow path for a fluid test sample. The working and counter electrodes are configured so that a major portion of the counter electrode is located downstream on the flow path from the working electrode with the exception of a small sub-element of the counter electrode which is in electrical communication with the primary portion of the counter electrode and located upstream of the working electrode. This configuration enables the sensor when the capillary space is incompletely filled with test fluid.

Abstract: A pressure ring for a lancing device for holding open a skin puncture while collecting a blood sample includes a collar that fits onto the end of a lancing device. A skirt is provided on the collar and a flared portion depends from the skirt. At least one axial slit is formed in the skirt. The pressure ring is made of a flexible material such as polypropylene such that when the lancing device with a pressure ring is placed on a person's skin and pressure is applied, the slits spread apart stretching the skin for a puncture by a lance in the lancing device. Once a puncture has been made, the pressure ring holds the puncture wound open to allow bleeding. Removing the lancing device from the puncture site releases the skin allowing the puncture wound to close.

Abstract: An apparatus (26) for mounting a display screen (28) to a printed circuit board (32). The display screen (28) has four edges. The apparatus (26) includes a top member (34) opposed to a bottom member (36), and first and second snap-fit members (40). The top member (34) and the bottom member (36) each form an overhang (38), wherein each overhang (38) is adapted to receive an edge (30) of the display screen (28). The first snap-fit member (40) is connected with and extended outwards from the top member (34). The second snap-fit member (40) is also connected with and extended outwards from the bottom member (36). Both the first and the second snap-fit members (40) are adapted to connect with the printed circuit board (32) for snap-fit assembly of the mounting apparatus (26) to the printed circuit board (32).

Abstract: A lancing mechanism for puncturing skin is provided. The lancing mechanism comprises a lance having a penetration end which is adapted to puncture skin. The penetration end of the lance is movable from a first position to a second position during a forward stroke and between the second position and the first position during a return stroke. A forcing plunger applies a force to the lance to move the lance from the first position to the second during the forward stroke. The forcing plunger is adapted to engage the lance during the forward stroke to move the penetration end of the lance from the first position to the second position and to disengage the lance when the penetration end of the lance approaches the second position. A first resilient member coupled to the lance moves the first end of the lance from the second position to the first position during the return stroke.

Abstract: A test strip is provided for use in the determination of the concentration of an a chemical in blood. The test strip comprises a plurality of microneedles and a test area. Each microneedle is adapted to puncture skin and to draw blood. The test area is in fluid communication with the microneedles. The test area contains a reagent adapted to produce a reaction indicative of the concentration of the chemical in blood.

Abstract: A system, method and biosensor apparatus are provided for data communications with a personal data assistant. The biosensor apparatus includes a sensor for receiving a user sample to be measured and a microcontroller for performing a predefined test sequence for measuring a predefined parameter value. An interface logic block is coupled to the microcontroller for communicating the predefined parameter data value to the personal data assistant. The personal data assistant provides an operator interface, data management and analysis of biosensor results.

Abstract: A lance is provided for puncturing skin and producing a sample of blood. The lance comprises a spring having a first end and a second end disposed between a needle and a base wherein the first end of spring is coupled to the base and the second end of the spring is coupled to the needle.

Abstract: Disclosed is an electrochemical sensor for detecting the concentration of an analyte such as glucose in a fluid test sample. The sensor involves a base as flow path for the fluid test sample having a working and counter electrode on its surface. The base is mated with a cover to form a capillary space to capture the fluid and the counter electrode has a sub-element located upstream in the flow path. When there is detected electrical communication only between the sub-element and the working electrode the meter, with which the sensor is in electrical communication senses that the capillary space has not completely filled with test fluid.

Abstract: The present invention relates to methods for the production of a stable troponin preparation and its use as a calibrator and/or control in immunoassays. The formulation is prepared from mammalian, preferably bovine, heart tissue which provides a calibrator/control composition which remains stable over a long period of time.

Abstract: An optical sensor for measuring the volume of an object, the object having a top and a side. The optical sensor comprises a source of light and a light sensor adapted to measure the amount of light reflected off the side and off the top of the object, wherein the measured amount of the light reflected off the side and the top of the object correlates to a height and a diameter of the object. At least one optical device is adapted to direct light reflected off the side of the object to the light sensor, and at least one optical device is adapted to direct light reflected off the top of the object to the light sensor.

Abstract: An adjustable endcap for a lancing device includes a basecap and a twistcap. The basecap includes a post with detents thereon. At least one finger is provided on the basecap adjacent the post. The twistcap includes at least one helical track on its outer surface into which the finger extends when the twistcap is mounted on the post. The twistcap also includes a plurality of grooves on an inner surface for engagement with the detents. As the twistcap is rotated on the post, the interaction of the finger and track causes the twistcap to move toward and away from the basecap and to adjust the penetration depth of a lance reciprocally mounted in the lancing device.

Abstract: Disclosed is a method for determining the concentration of an analyte in a sample of body fluid. The method involves contacting the body fluid sample with a test strip containing mobile, labeled specific binding partner for the analyte, through which strip the test fluid, analyte and any complex formed by interaction of the analyte and labeled specific binding partner therefore can flow by capillarity. The strip contains at least one zone for capture of the labeled specific binding partner and at least one separate zone for retention of the analyte/labeled specific binding partner complex. By determining the magnitude of the signal from the detectable label in the capture zone(s) and retention zone(s) and determining a final response signal by correlating signals using an algorithm and number of zones chosen in a manner that provides a final response signal best suited for the particular assay, the concentration of the analyte can be determined with greater precision.

Abstract: The present invention is an improvement to the method of determining the concentration of an analyte in body fluid using at least two immunoreactants which specifically bind with separate epitopes of the analyte one of which immunoreactant is immobilized on a solid support and the other is in the form of a polymer or oligomer of the immunoreactant and an enzyme. The improvement involves introducing to the assay system a polymeric conjugate of the enzyme and a water soluble protein other than the enzyme or a non-proteinaceous natural, synthetic or semi-synthetic polymer or oligomer in sufficient amount to reduce bias in the assay due to incorrect recovery of the analyte.

Abstract: A method and apparatus are provided for correcting ambient temperature effect in biosensors. An ambient temperature value is measured. A sample is applied to the biosensors, then a current generated in the test sample is measured. An observed analyte concentration value is calculated from the current through a standard response curve. The observed analyte concentration is then modified utilizing the measured ambient temperature value to thereby increase the accuracy of the analyte determination.