Abstract: A system is provided for adapting one of a number of different types of instruments to a common protocol. Each instrument has a serial input-output (I/O) port, a control for the serial I/O port, and an input for operating power to the instrument. The system includes a different type of housing for each different type of instrument. Each different type of housing includes openings through which selected controls and displays of a respective one of the instruments are accessible. Each different type of housing includes couplers for coupling to a respective type of instrument's serial I/O port, and to a respective type of instrument's operating power input, and a data processing module including a first multiple conductor. Each type of housing includes a complementary second multiple conductor connector for connecting to the first multiple conductor connector when a respective housing is mated to the data processing module.

Abstract: A biosensing meter is enabled to receive a sample strip that includes a sample well with an analyte reactant therein and electrodes in contact therewith. The biosensing meter includes an excitation supply for supplying potentials to a sample strip electrode. A sense amplifier is also provided for connection to another electrode of an inserted sample strip and produces an output signal indicative of sensed currents when an analyte containing fluid is present in the strip's sample well. A pluggable memory key is insertable into the meter and includes a plurality of stored parameter values and procedure routines that control operations of the meter. A microprocessor is responsive to a procedure routine and parameter values accessed from the pluggable memory key to cause the excitation supply to apply a plurality of potentials for preset durations, both the values of the potentials and the time duration of their application determined from parameter values derived from the memory key.

Abstract: The invention is an apparatus useful in carrying out an analytical assay. The apparatus has a positive and negative control, as well as a site for determining the presence, amount, or lack of an analyte in a sample.

Abstract: A biosensing meter receives a sample strip that includes electrically isolated sense and excitation electrodes bridged by a reaction zone. When a drop of biological sample fluid is placed in the reaction zone, a plurality of fail/safe tests are performed. A drop size test is performed by a circuit that detects the size of the drop placed in the reaction zone. The circuit both detects that a drop has been placed in the reaction zone and further measures a test current level, after a delay, to determine that the drop size is sufficient to enable hydration of reactants in the reaction zone. Subsequently, during the reaction, a "delta" current change is measured at succeeding sample time. This test measures the difference between succeeding current samples during a measurement time. If each succeeding sample is not less than preceding sample by a delta value, a determination is made that the current is not monotonically decreasing and the test is aborted.

Abstract: Control reagents an oxidant or a hydroxylamine compound together with other ingredients, the most important of which is a known amount of the analyte for which the reagent acts as a control.

Abstract: A biosensor that includes working and counter electrodes of substantially the same size and made of the same electrically conducting material. A reagent is contained in a reagent well in the biosensor. The reagent includes a redox mediator, an enzyme, and a buffer, and covers substantially equal surface areas of portions of the working and counter electrodes. When a sample, containing the analyte to be measured, is added to the reagent well, a reaction occurs that oxidizes the analyte and reduces the redox mediator. After this reaction is complete, an electrical potential difference is applied between the electrodes. The amount of oxidized form of the redox mediator at the counter electrode and the applied potential difference must be sufficient to cause diffusion limited electrooxidation of the reduced form of the redox mediator at the surface of the working electrode.

Abstract: A method and apparatus for verifying the operating accuracy of an instrument (10) for detecting the concentration of a medically significant component of a body fluid. The instrument (10) operates by determining the remission of a reacted chemistry contained on a substrate (106) after the chemistry has reacted with the medically significant component of the body fluid. The instrument (10) includes a radiation source (182), a radiation detector (300) and a pathway (164) from the radiation source (182) to the chemistry (106) and from the chemistry (106) to the radiation detector (300) when the substrate (106) is properly inserted into the instrument (10). The remission of the chemistry (106) determines the radiation detected by the radiation detector (300).

Abstract: The operative site of an assay device is dosed with a controlled volume of a liquid specimen by a holding device which holds the controlled volume of specimen in contact with the operative site, although the holding device remains out of contact with the operative site. A sink device is in contact with the margin of the holding device and moves excess specimen away from the holding device. In one embodiment the device makes possible a non-wipe teststrip architecture. The device can be used in the detection of analytes including glucose or cholesterol in blood or urine and can be interrogated visually, optically or electrically, depending on the reagent used at the operative site.

Abstract: Non-aqueous, polymeric reagent film compositions for use with analytical test devices of the dry chemistry type are described. The film compositions are prepared from an organic solution of a copolymer formed by interaction of at least two monomers wherein(a) the first monomer is a hydroxylated acrylate of the general formula ##STR1## where R1 is hydrogen or, more preferably, methyl, and R2 is a hydroxyalkyl group having from 1 to 5 carbon atoms, and(b) the second monomer is a neutral acrylate of the general formula ##STR2## where R1 is hydrogen or, more preferably, methyl, and R3 is a substituted or unsubstituted alkyl group having from 1 to 8 carbon atoms.Preferably, a third monomer is also included which is an amine-containing acrylate of the general formula ##STR3## where R1 is hydrogen or, more preferably, methyl, and R4 is a substituted or unsubstituted aminoalkyl or glycidyl group having from 1 to 5 carbon atoms or a surfactant polyethylene glycol group having from 10 to 30 carbon atoms.

Abstract: A method and apparatus (10) for determining the remission of a chemistry (106) which reacts with a medically significant component of a body fluid. The remission of the chemistry (106) changes as it reacts. The method and apparatus (10) include irradiating the chemistry (106) with a radiation source (182), detecting remissions of radiation from the chemistry (106) with a radiation detector (300), providing a radiation pathway (164) between the source (182) and the chemistry (106), providing a remission pathway (164) between the chemistry (106) and the detector (300), and detecting the rate of change of remission of the chemistry (106) with respect to time.

Abstract: A biosensing system is described which determines whether a measured current is varying in accordance with a predetermined Cottrell current relationship. The system includes a test cell with at least a pair of electrodes which extend into a reaction zone, which reaction zone includes analyte reactants. An analog signal detector, in combination with a microprocessor, take plurality of current measurements between the electrodes over a plurality of succeeding measurement times, after a sample is placed in contact with the analyte reactants in the reaction zone. The microprocessor also stores a plurality of succeeding cpmparison constants which are derived by taking the inverse ratio of the square root of a measurement time divided by the square root of a subsequent measurement time.

Abstract: The invention relates to an assay for determining an analyte in a fluid sample. Three receptors are used, with formation of a quaternary or four member complex. One of the receptors is bound to a solid phase, and binds to complexes of another receptor and the analyte. A third receptor is labelled, and it, too, binds analyte. The invention also involves the use of a displacement solution to wash fluid sample from solid phase after the first portion of the quaternary complex forms, i.e., prior to binding with the labelled receptor.

Abstract: An instrument for analyzing test strips supporting chemistries which react with a medically significant component of a body fluid to indicate the concentration of the component in the body fluid. The instrument includes a pathway along which radiation is guided from a radiation source to a strip when the strip is inserted into the instrument and along which remission is guided from the strip to a radiation detector. A title provided on the instrument provides a first remission when no strip is inserted into the instrument. The tile is separated from the radiation source by the strip when the strip is inserted into the instrument. The first remission and the strip's remission, respectively, indicate the absence and the presence of the strip in the instrument. The strip also has a surface opposite the chemistry supporting surface characterized by a second strip remission different from the first strip remission.

Abstract: An apparatus for determining an analyte in a sample, as well as a method for carrying this out, are disclosed. The apparatus utilizes a first zone containing a labeled substance, and a second zone which permits separation of a mobile detectable moiety from unreacted reaction component. Detectable moiety is the product of reaction between reaction component and labeled substance.

Abstract: A tourniquet cuff for reducing blood flow in a patient's limb includes a backing plate having an inner and outer side. A flexible covering having an inner and outer side is also provided. The flexible covering is formed to be substantially more pliable than the backing plate. The backing plate and the flexible covering are attached to each other to define an inflation cavity between the inner side of the backing plate and the inner side of the flexible covering. An inflatable bladder is positioned in the inflation cavity and the tourniquet is secured about a patient's limb with the outer side of the flexible covering in contact with the patient's limb.

Abstract: The present invention provides an actuator mechanism for sequentially advancing and retracting a lancet needle and includes a drive carriage for advancing and retracting the lancet needle and a hinge structure operatively connected to displace the drive carriage. The hinge structure includes first and second coupled leaf members relatively pivotal between a first position thereof in which the drive carriage is advanced to project and thrust the lancet needle into a tissue penetration position, and the second pivotal position of the leaf members in which the drive carriage is retracted to withdraw the lancet needle from the penetration position. The leaf members can also be pivotal to a third position in which the drive carriage is retracted prior to initiating the advancement so that the first position of the leaf members is pivotally intermediate between the second and third relative positions thereof.

Abstract: A modular joint prosthesis for implantation in a body. A component adapted to be fixed to a long bone having an intramedullary canal includes an elongated male stem having a uniformly tapered outer surface. In order to accommodate the particular size of long bone to which the component is to be fixed, a properly sized female stem is attached to the male stem before the component is fixed to the long bone. The female stem is adapted to be received in the intramedullary canal for fixation thereto, and has a uniformly tapered inner surface, the angle of the taper being substantially similar to the angle of taper of the outer surface of the male stem. As a result, the male stem and female stem become locked together when the inner surface of the female stem engages the outer surface of the male stem. The proper size of female stem is obtained by selecting it from a family of female stems having a graduated sequence of different external dimensions.

Abstract: A modular hip prosthesis for the replacement of a portion of the femur is provided. The prosthesis is assembled from a kit that includes a stem member having an upper portion and a lower portion, with the lower portion sized to be received in the femur. The kit also includes a body member that is sized to replace a portion of the femur and is configured to be received over the upper portion of a stem member. The kit also includes a head member that is sized to replace the head of the femur. A neck member is provided to attach the head member to the body member to form an assembled prosthesis.

Abstract: An assembly (10) for positioning a prosthetic acetabular cup assembly (110) in a patient's hip is provided. The assembly (10) includes a bearing component (114) having an inner bearing surface (134) for receiving a femoral ball and an outer surface (132) attachable to a shell component (112) The shell component (112) is attached to an acetabulum to replace a natural hip socket. The shell component (112) includes an inner surface (120) defining a cavity (126) for receiving the outer surface (132) of the bearing component (114) therein. The assembly (10) includes a handle (12) attached to a split head (30). The split head (30) is divided into first and second gripping elements (36, 38) that jointly form a gripping surface to engage the inner bearing surface (134) of the bearing component (114). The assembly (10) holds the bearing component (114) at a selected orientation with relation to the shell component (112), and is used to drive the bearing component/shell component (114/112) into the acetabulum.