Calibration material delivery devices and methods

• US 9,897,610 B2
• Filed: 12/01/2014
• Issued: 02/20/2018
• Est. Priority Date: 11/30/2009
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Lipman, Kelley J., Tomasco, Michael F., Ly, Peter Uy-Vu, Blomo, Jennifer Y., Reynolds, Paul D., Larkin, John F., Gaffney, Robin S., Tansey, Kimberly J., Stewart, Christopher L., Escutia, Ral, Bowers, Robert W.
• Primary Examiner(s): Le, Toan
• Application Number:
  US14/557,327
• Publication Number:
  US 20150153351A1
• Time in Patent Office: 1,177 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: B01L 2200/148 Specific details about calibrations
• CPC Class Codes: B01L 2300/022 Transponder chips
• CPC Class Codes: B01L 2300/123 Flexible; Elastomeric
• CPC Class Codes: B01L 2400/0481 squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/523 with means for closing or opening
• CPC Class Codes: G01N 21/78 producing a change of colour
• CPC Class Codes: G01N 2201/12707 Pre-test of apparatus, e.g. dark test, sensor test
• CPC Class Codes: G01N 2496/80 Multi-analyte reference solutions containing cholesterol, glucose and the like
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48785 Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: Y10T 436/10 : Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/107497 : Preparation composition [e.g., lysing or precipitation, etc.]

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.

Claims

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.

2. The method of claim 1 further comprising detecting the presence of a control solution device with the analyte monitoring device.

3. The method of claim 1 further comprising lancing a control solution device with the analyte monitoring device to extract the control solution therein.

4. The method of claim 1 wherein identifying the control solution comprises analyzing the control solution using a colorimetric technique.

5. The method of claim 1 wherein identifying the control solution comprises analyzing the rate of reaction of the solution material.

6. The method of claim 1 wherein identifying the control solution comprises analyzing the wavelength of the control solution.

7. The method of claim 1 wherein the at least one analyte comprises glucose.

8. The method of claim 1 wherein the test cartridge comprises a multi-test cartridge.

9. The method of claim 1 wherein the control information is contained in a barcode or RFID chip associated with the test cartridge.

10. The method of claim 1 further comprising storing the control information in a memory of the analyte monitoring device.

11. The method of claim 1 wherein the analysis site comprises a reagent.

12. A system for verifying the accuracy of an analyte monitoring device through a control test, the system comprising:

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.

13. The system of claim 12 further comprising a control solution device containing the control material therein.

14. The system of claim 13 wherein the analyte monitoring device is configured to detect the presence of the control solution device.

15. The system of claim 13 wherein the analyte monitoring device is configured to lance the control solution device to extract the control solution.

16. The system of claim 12 wherein the instructions that cause the processor to determine the presence of the control solution comprise instructions that cause the processor to analyze the control solution using a colorimetric technique.

17. The system of claim 12 wherein the instructions that cause the processor to determine the presence of the control solution comprise instructions that cause the processor to analyze the rate of reaction of the control solution.

18. The system of claim 12 wherein the instructions that cause the processor to determine the presence of the control solution comprise instructions that cause the processor to analyze the wavelength of the control solution.

19. The system of claim 12 wherein the at least one analyte comprises glucose.

20. The system of claim 12 further comprising a test cartridge.

21. The system of claim 20 wherein the test cartridge comprises a multi-test cartridge.

22. The system of claim 20 wherein the information is contained in a barcode or RFID chip associated with the test cartridge.

23. The system of claim 12 wherein the analyte monitoring device is configured to store the control information in the non-transitory memory.