Calibration material delivery devices and methods
First Claim
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1. A method of verifying the accuracy of an analyte monitoring device through a control test, the method comprising:
- receiving control information from a test cartridge with the analyte monitoring device, wherein the control information comprises a range of analyte concentration values for a control solution;
transporting the control solution to an analysis site in the test cartridge, wherein the control solution has a known and/or predetermined concentration of at least one analyte;
determining the presence of the control solution using the analyte monitoring device, wherein determining the presence of the control solution comprises identifying the control solution;
analyzing the control solution to measure the concentration of the at least one analyte contained therein;
comparing the measured concentration of the at least one analyte with the control information to determine if the measured concentration corresponds to the range of concentration values obtained from the control information; and
providing a pass or fail signal to indicate whether the measured concentration falls within the range of analyte concentration values.
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Abstract
A device includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. Methods for verifying the accuracy of an analyte monitoring device include receiving control information from a test cartridge, transporting control material to an analysis site, determining the presence of the control material, analyzing the control material, and providing a pass or fail signal.
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Citations
23 Claims
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1. A method of verifying the accuracy of an analyte monitoring device through a control test, the method comprising:
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receiving control information from a test cartridge with the analyte monitoring device, wherein the control information comprises a range of analyte concentration values for a control solution; transporting the control solution to an analysis site in the test cartridge, wherein the control solution has a known and/or predetermined concentration of at least one analyte; determining the presence of the control solution using the analyte monitoring device, wherein determining the presence of the control solution comprises identifying the control solution; analyzing the control solution to measure the concentration of the at least one analyte contained therein; comparing the measured concentration of the at least one analyte with the control information to determine if the measured concentration corresponds to the range of concentration values obtained from the control information; and providing a pass or fail signal to indicate whether the measured concentration falls within the range of analyte concentration values. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A system for verifying the accuracy of an analyte monitoring device through a control test, the system comprising:
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an analyte monitoring device comprising a non-transitory memory and a processor, wherein the non-transitory memory is programmed with instructions that cause the processor to; receive control information from a test cartridge, wherein the control information comprises a range of analyte concentration values for a control solution; determine the presence of the control solution by identifying the control solution, wherein the control solution has a known and/or predetermined concentration of at least one analyte; analyze the control solution to measure the concentration of the at least one analyte contained therein; compare the measured concentration of the at least one analyte with the control information to determine if the measured concentration corresponds to the range of analyte concentration values obtained from the control information; and provide a pass or fail signal to indicate whether the measured concentration falls within the range of concentration values. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23)
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Specification