Abstract: A fitment for use with a flexible container having a lower fitment member with a fluid conducting opening in a top surface and an upper fitment member with an upper fitment opening in an upper fitment bottom surface where the fluid conducting opening and the upper fitment opening form a fluid passageway or conduit. A wall of the flexible container is compressibly held between the top surface of the lower fitment member and the upper fitment bottom surface. The fitment may also include one or more additional walls of one or more additional flexible containers forming a bag-in-a-bag structure.

Abstract: A concentrated and ligand-coated gold colloid and a method of preparing it. Also disclosed is a rapid biomolecule quantification assay involving the use of the concentrated gold colloid and an apparatus for performing the assay.

Abstract: A method of obtaining a test sample from a specimen using a lancet system includes engaging a lancet driver against a drive wing of a lancet system, the lancet system having a major portion of a lancet member slidably engaged within a lancet carrier and a sensor strip with a sample chamber attached to the lancet carrier, the lancet system having a lance connected to a first end of a lancet body of the lancet member wherein the lance is movable from a retracted position within the lancet carrier to an extended position outside the lancet carrier, the drive wing extending outwardly and transversely from the lancet body, the major portion of the lancet member having a sinuous portion with a distal end restricted from movement by the lancet carrier, the sinuous portion being non-compressible when initially disposed within the lancet carrier wherein the drive wing prevents the sinuous portion from being compressed, moving the drive wing with the lancet driver a predetermined distance causing the lancet tip to move

Abstract: A system for more accurately measuring glucose in a sample includes a first glucose-sensing electrode incorporating a quantity of glucose oxidase, a second glucose-sensing electrode incorporating a quantity of PQQ-glucose dehydrogenase, a reference electrode, and means for selecting between a first glucose measurement made with the first glucose-sensing electrode and a second glucose measurement made with the second glucose-sensing electrode.

Abstract: A bilirubin sensor has a working electrode with a first chemical matrix disposed thereon that contains a binder, a substrate electrode with a second chemical matrix dispose thereon that contains a binder and a chemical agent that consumes bilirubin, a reference electrode, a sample chamber containing the working electrode, the substrate electrode and the reference electrode, and a method of measuring bilirubin in a body fluid.

Abstract: A biosensor for measuring an analyte in a liquid sample includes a working electrode having a dispensed reagent thereon wherein the dispensed reagent contains an enzyme capable of catalyzing a reaction involving the analyte, a mediator that is considered an enzyme inhibitor, and an enzyme co-factor where the working electrode provides a stable and sensitive response even when the biosensor is stored at ambient conditions for a period of time selected from the group consisting of at least 3 months, 12 months and two years or.

Abstract: A concentrated and ligand-coated gold colloid and a method of preparing it. Also disclosed is a rapid biomolecule quantification assay involving the use of the concentrated gold colloid and an apparatus for performing the assay.

Abstract: A lancet carrier for an integrated lancet sensor assembly incorporating a lance cover includes an elongated body with a bottom, an open top, a body open end and a body closed end, a lancet-receiving recess with a recess bottom surface, the recess extending between the open end and the closed end, and a trough-forming member forming a trough with a trough open end in communication with the body open end, the trough-forming member longitudinally extending a predefined distance along the bottom from the body open end, the trough replacing a portion of the recess bottom surface at the body open end.

Abstract: A bilirubin sensor has a working electrode with a first chemical matrix disposed thereon that contains a binder, a substrate electrode with a second chemical matrix dispose thereon that contains a binder and a chemical agent that consumes bilirubin, a reference electrode, a sample chamber containing the working electrode, the substrate electrode and the reference electrode, and a method of measuring bilirubin in a body fluid.

Abstract: A lancet assembly has a lancet body with a needle end, a sinuous portion end, and a slot, a lancet tip connected to the needle end, a sinuous portion connected to the sinuous portion end, an anchor structure connected to the sinuous portion. The lancet assembly may also include a lancet enclosure having an elongated chamber with a needle end, an anchor end in communication with the elongated chamber opposite the needle end, and a lancet enclosure slot in communication with the elongated chamber and spaced from the needle end. The anchor end is configured to receive and hold the anchor structure in a substantially static position. The elongated chamber is sized to receive in sliding engagement the lancet tip, the lancet body where the lancet body slot is in communication with the lancet enclosure slot and the sinuous portion and to permit slidable movement of the lancet tip through the open end between a retracted position and an extended position.

Abstract: A blood glucose measuring system includes a lancet assembly and a meter for use with the lancet assembly. The lancet assembly has a lancet member with a lance, a lancet body having a drive wing extending outwardly from a side, and a sinuous portion, and an elongated carrier having a lancet member recess to contain the lancet member. The elongated carrier has an open end, a closed end, a side elongated opening for receiving the drive wing therethrough, and an anchoring member operatively connected to the end of the sinuous portion. The meter includes a measuring circuit, a lancet trigger, and a lancet driver where the lancet driver includes a driver piston engageable with the lancet trigger and a charging member that operatively engages with the driver piston to move the driver piston into an armed position and to stop the driver piston when released from the armed position.

Abstract: A shear valve assembly includes a stationary valve manifold having a manifold planar surface containing a plurality of manifold input ports and one or more manifold output ports, a movable valve switch having a switch planar surface in slidable, interactive contact with the manifold planar surface forming an interactive contact junction, the switch planar surface having a fluid switching channel capable of connecting one of the plurality of manifold input ports with one of the one or more manifold output ports, a surface modifying component disposed at the interactive contact junction that provides a period of extended useful life of the manifold planar surface and the switch planar surface beyond the useful life of pre-lubricated interactive contact junction, a drive shaft connected to the valve switch, and a valve housing supporting the stationary valve manifold, the movable valve switch, and the drive shaft.

Abstract: A single-use lancet cartridge for inserting into a multi-use lancet driver assembly includes an elongated lancet housing with an open end, a lancet within the lancet housing and movable between a retracted and resting orientation to a piercing orientation through the open end, and a re-use prevention component incorporated within the lancet cartridge and oriented to cooperatively engage with a driver piston of the multi-use lancet driver assembly only one time thereby preventing the lancet from being moved into a piercing orientation a second time. The single-use lancet cartridge is used that contains the multi-use lancet driver assembly.

Abstract: An oxygen sensor has a laminated body with a fluid sample inlet end and an electrical contact end, a fluid sample inlet, a substantially flat test chamber communicating with the fluid sample inlet where the test chamber is adapted to collect a fluid sample through the sample fluid inlet, a working electrode and a reference electrode within the test chamber, and a reagent matrix disposed on the working electrode where the reagent matrix contains an oxidase, a reduced form of a redox mediator and a peroxidase.

Abstract: A reagent matrix composition disposed on an electrically conductive electrode to form an in-vivo sensor for a predefined analyte includes a first hydrogel layer containing an enzyme that is a substrate for the analyte adjacent the electrically conductive electrode and a composite membrane layer disposed onto the first hydrogel layer where the composite layer includes a membrane hydrogel containing a plurality of microspheres. The plurality of microspheres is made of a material having no or little permeability to the analyte and a substantially high permeability to oxygen.

Abstract: An in-vivo sensor assembly includes an assembly body having a body proximal end and a body distal end, a plurality of sensor elements including at least an analyte sensor element containing an enzyme that is a substrate of the analyte to be measured, a reference sensor element and a temperature sensor element disposed at or near the body distal end wherein the at least an analyte sensor element and the reference sensor element are exposed to the sample fluid and the temperature sensor is capable of measuring the temperature of and adjacent to the analyte sensor element, and an electrical coupling means disposed at the body proximal end and configured to couple to the at least an analytical sensor element, the reference sensor element and the temperature sensor element.

Abstract: A system and method for correcting the oxygen effect on oxidase-based analyte sensors includes an oxygen sensor with a working electrode, a reagent matrix disposed on at least the working electrode that contains a reduced form of a redox mediator, an oxidase and a peroxidase, an oxidase-based analyte sensor, a means for determining the oxygen concentration in a portion of a fluid sample using the oxygen sensor, means for determining an analyte concentration in another portion of the fluid sample using the oxidase-based analyte sensor, and means for using the oxygen concentration in the fluid sample to determine a corrected analyte concentration in the fluid sample.

Abstract: An intravascular sensor assembly insertable into an intravenous catheter, the sensor assembly includes a sheath having a sheath proximal end and a sheath distal end wherein an outer diameter of the sheath is sized to be substantially equal to the outer diameter of an insertion needle of the intravenous catheter, a hub sealingly connected to the sheath proximal end, the hub adapted for removably coupling to the intravenous catheter, a sensor disposed within the sheath, the sensor having a sensor shank with a shank distal end and a shank proximal end, a plurality of sensor elements including a working electrode with a reagent matrix disposed thereon, the reagent matrix comprising an enzyme capable of catalyzing a reaction involving a substrate for the enzyme and a reference electrode, the plurality of sensor elements disposed adjacent the shank distal end, a plurality of connector pads disposed at the shank proximal end where the plurality of connector pads are contained within the hub and the plurality of sens

Abstract: A method of compensating for the presence of hematocrit in a blood sample when measuring a blood analyte using a disposable sensor strip. The method includes disposing a blood sample onto a working electrode and a reference electrode of the disposable sensor strip to obtain a concentration of an analyte in the blood sample, measuring a resistance value of the blood sample between the reference electrode and the working electrode, and calculating a corrected concentration of the analyte using the resistance value and a hematocrit equation to correct for the presence of hematocrit in the blood sample.

Abstract: An improved biosensor having at least a first working electrode and a first electrode material disposed on the first working electrode. The first electrode material is a mixture made by combining at least one enzyme where the at least one enzyme is a capable of reacting with the analyte to be measured, a redox mediator capable of reacting with a product of an enzymatic reaction or a series of enzymatic reactions involving the at least one enzyme, a peroxidase capable of catalyzing a reaction involving the redox mediator where the redox mediator is oxidized, a binder and a surfactant.