Abstract: A system for determining a level of hematocrit includes a test strip configured to receive a sample; a meter configured to receive the test strip; and further including circuitry and a microprocessor, the circuitry and microprocessor configured to apply electrical energy to the test strip and the sample and determine an electrical property of the sample, either the impedance phase angle or the impendence magnitude of the test strip and the sample and, based on the electrical property, calculate the level of hematocrit in the sample.

Abstract: A method includes lysing the red blood cells of a whole blood sample, oxidizing the free hemoglobin in the lysed sample, and cleaving FVH from the hemoglobin A1C to form an electrochemical test solution. A first portion of the electrochemical test solution is reacted with fructosyl peptide oxidase and a reduced ruthenium mediator to form a first reaction product. A first electrical property of the first reaction product is measured, the measurement being indicative of hemoglobin A1C in the blood sample. A second portion of the electrochemical test solution is reacted with ferrocyanide to form a second reaction product. A second electrical property of the second reaction product is measured, the measurement being indicative of total hemoglobin in the blood sample. Hemoglobin A1C, total hemoglobin, and % HbA1C are determined based on the first and second electrical properties. Also provided are systems and components useful in performing the disclosed methods.

Abstract: A system for processing a sample includes a unitary body. The unitary body including a snap lid, the snap lid having a capillary. The unitary body including a lysing container. The unitary body including a test element and a sliding actuator.

Abstract: In one embodiment, a system for a configurable meter for analyte testing includes a meter, the meter configured to respond to commands in a first protocol and thereby control an analysis system for detecting an analyte level of an analyte, a display, and an input device. The system further includes a removable chip insertable into the meter, the removable chip configured to execute a protocol when mated with the meter and send the commands in the first protocol to control the meter, the removable chip further configured to calculate the analyte level as part of the protocol.

Abstract: In one embodiment, a system for detecting an analyte in a bodily fluid sample includes an electrochemical biosensor, the electrochemical biosensor configured to receive the bodily fluid sample, test for the analyte, and produce an analyte level for the analyte. The system further includes a mediator, the mediator configured to provide for the testing of the analyte by facilitating electron exchange between the analyte and the biosensor. The system further includes an oxygen tension reducing agent, the oxygen tension reducing agent reducing interference of oxygen with the operation of the mediator.

Abstract: An electrochemical test for total cholesterol includes a test strip for an electrochemical testing testing of a blood analyte which includes a first receiving port, the first receiving port for receiving a blood sample, the first receiving port at a first end of the test strip. The test strip further includes a first electrode and a second electrode, the first and second electrodes proximate to the first receiving port. The test strip further includes a first contact and a second contact, the first and second contacts at a second end of the test strip, the first and second contacts interconnected with the first and second electrodes, respectively. The test strip further includes cholesterol oxidase, located proximate to the first and the second electrode. The test strip further includes a mediator, located proximate to the first and the second electrode, wherein the cholesterol oxidase and the mediator interact with the blood sample and the first and second electrode to generate a measurable electrical event.

Abstract: A system for determining a concentration of hemoglobin A1C includes a first electrochemical test strip, the first electrochemical test strip providing for an HbA1C concentration; and a second electrochemical test strip, the second electrochemical test strip providing for the total amount of hemoglobin.

Abstract: A method for determining analytes includes lysing the red blood cells of a whole blood sample, oxidizing the free hemoglobin in the lysed sample, and cleaving FVH from the hemoglobin A1C to form an electrochemical test solution. In one aspect, a first portion of the electrochemical test solution is reacted with fructosyl peptide oxidase and a reduced ruthenium mediator to form a first reaction product. A first electrical property of the first reaction product is measured, the measurement being indicative of hemoglobin A1C in the blood sample. In another aspect, a second portion of the electrochemical test solution is reacted with ferrocyanide to form a second reaction product. A second electrical property of the second reaction product is measured, the measurement being indicative of total hemoglobin in the blood sample. Hemoglobin A1C, total hemoglobin, and % HbA1C are determined based on the first and second electrical properties.

Abstract: A system for determining a level of hematocrit includes a test strip configured to receive a sample; a meter configured to receive the test strip; and further including circuitry and a microprocessor, the circuitry and microprocessor configured to apply electrical energy to the test strip and the sample and determine an electrical property of the sample, either the impedance phase angle or the impedance magnitude of the test strip and the sample and, based on the electrical property, calculate the level of hematocrit in the sample.

Abstract: A system for preparing a sample containing hemoglobin HbA1c for measurement by an electrochemical sensor includes a lysing formulary, the lysing formulary including a zwitterionic surfactant. The system further includes a oxidizing formulary, the oxidizing formulary including a cationic surfactant and a isothiazoline derivative and a protease formulary, the protease formulary including a molecule including an azole.

Abstract: A system for testing for an analyte includes a test strip. The test strip includes a first flow path. The test strip further includes a heating element in communication with a heating area of the first flow path, for heating a sample in the first flow path. The test strip further includes an e-gate, the e-gate in the first flow path, the e-gate separating the heating area from a detection area of the first flow path.

Abstract: A test strip for electrochemical testing of a blood analyte includes a plurality of test sites for the electrochemical testing of analytes on a single test strip. Each test site includes a first receiving port, the first receiving port for receiving a blood sample, the first receiving port at a first end of the test strip. The test site further includes a first electrode and a second electrode, the first and second electrodes proximate to the first receiving port. Each test site further includes a first contact and a second contact, the first and second contacts at a second end of the test strip, the first and second contacts interconnected with the first and second electrodes, respectively.

Abstract: In one embodiment, a system for determining the proper positioning of a test strip includes a test strip having a first reading window and a strip holder. The system further includes a meter, the meter receiving and configured to receive the test strip, the meter having a first light source of a first color and a second light source of a second color and a first read window. The meter is configured to illuminate the first light source; detect a first reflectance with the meter through the first read window; and determine if the first reflectance is greater than a no-strip value.

Abstract: A system for the electrochemical detection of triglyceride levels includes a test strip including an electrode and a counter electrode, the electrode and counter electrode located proximate to a sample reception area; and a coating on one of the electrode and counter electrode, the coating including a reagent coating for triglycerides.

Abstract: A blood sampler device includes a sampler body forming a hollow internal chamber with upper and lower openings, the sampler body including a sealing device disposed adjacent to the upper opening. The blood sampler device further includes a blood collector adapted to be inserted into the sampler body, the blood collector including a plurality of capillary channels.

Abstract: A linearity standard includes a plurality of calibration solutions, each calibration solution having a different level of a reactant having a known response in a test strip and meter combination, and an electronic storage medium for storing calibration instructions and known responses for each solution of the plurality of calibration solutions.

Abstract: Systems and methods for point-of-care determination of blood potassium are provided. The approaches are based on the reaction of ADP and PEP in the presence of potassium ion and pyruvate kinase to produce pyruvate and ATP. In one method, the produced pyruvate is reacted with phosphate and mediator, in the presence of pyruvate oxidase, to yield acetylphosphate and reduced mediator, and the reduced mediator is used to determine the blood potassium using conventional electrochemical methods. In an alternative method, the produced pyruvate is reacted with phosphate and oxygen in the presence of pyruvate oxidase to yield acetylphosphate and hydrogen peroxide, and the hydrogen peroxide is measured optically in accordance with known methods.

Abstract: A pinch wall and dam system for controlling fluid flow movement between a sample receiving pad and a test strip includes a sample receiving pad and a test strip in contact with the sample receiving pad. The fluid seeps more quickly under the first portion of the pinch wall than under the second portion of the pinch wall, such that the test strip becomes saturated prior to excess fluid being absorbed in the portion of the sample receiving pad away from the test strip such that the test strip does not become flooded, the portion of the sample receiving pad positioned away from the test strip being sufficiently sized to absorb the excess fluid. The pinch wall and dam system further includes a dam, sitting on top of the sample receiving pad, the dam preventing the backflow of fluid from an area near the first portion of the pinch wall.

Abstract: A system for the electrochemical detection of ketone levels includes a test strip including an electrode and a counter electrode, the electrode and counter electrode located in a sample reception area. The system further includes a coating on one of the electrode and counter electrode, the coating including a mediator for ketones. Optionally, the mediator is ferricyanide.

Abstract: A system for determining a concentration of hemoglobin A1C includes a first lateral flow test strip, the first lateral flow test strip providing for a percent of HbA1C concentration; a second lateral flow test strip, the second lateral flow test strip providing for the total amount of hemoglobin; an antibody-microparticle stripe on each of the first and second lateral flow test strips; a conjugate stripe on each of the first and second lateral flow test strips; and a sample treatment buffer. The sample treatment buffer is strongly denaturing, and antibodies in the antibody-microparticle strip are covalently bound to microparticles.