Method of manufacturing a disposable diagnostic meter

• US 20060275890A1
• Filed: 06/06/2005
• Published: 12/07/2006
• Est. Priority Date: 06/06/2005
• Status: Abandoned Application

• Current Assignee: Home Diagnostics Incorporated
• Original Assignee: Home Diagnostics Incorporated
• Inventors: Modzelewski, Brent E., Neel, Gary T., Casterline, Cameron Scott
• Application Number:
  US11/144,715
• Publication Number:
  US 20060275890A1
• Time in Patent Office: Days
• US Class Current: 435/287.200
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• CPC Class Codes: A61B 5/150259 Improved gripping, e.g. with high friction pattern or projections on the housing surface or an ergonometric shape
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/48778 Containers specially adapted therefor, e.g. for dry storage

Abstract

A method for manufacturing a diagnostic testing system is provided. Various methods are described for calibrating the test system to work with selected test media compatible with the calibration to provide accurate results. The methods eliminate the need for any kind of user-coding. Packaging only compatible selected diagnostic test media with the calibrated meter can include at least one container for enclosing the diagnostic test media, wherein the container can be physically coupled to the diagnostic meter.

Claims

1. A method for manufacturing a diagnostic testing system, comprising:

producing a diagnostic meter configured to measure the concentration of one or more analytes in a sample;

pre-selecting one or more diagnostic test media having substantially similar functional properties for use with the diagnostic meter;

calibrating the diagnostic meter such that, in use, said meter is capable of accurately measuring the concentration of one or more analytes using the pre-selected diagnostic test media; and

packaging the pre-selected diagnostic test media with the calibrated meter and at least one container for enclosing the diagnostic test media, wherein the container can be physically coupled to the diagnostic meter.

2. The method of claim 1, wherein the sample comprises body fluid.

3. The method of claim 2, wherein the sample is blood.

4. The method of claim 1, wherein the sample includes a non-medical sample.

5. The method of claim 4, wherein the sample includes water.

6. The method of claim 1, wherein the one or more analytes includes glucose.

7. The method of claim 1, wherein calibrating the diagnostic meter includes configuring the test meter software to allow the meter to accurately measure the concentration of one or more analytes using the pre-selected diagnostic test media.

8. The method of claim 1, wherein calibrating the diagnostic meter includes configuring the test meter hardware to allow the meter to accurately measure the concentration of one or more analytes using the pre-selected diagnostic test media.

9. The method of claim 1, further including configuring the diagnostic test meter to stop functioning after performing a number of diagnostic tests no less than the number of test media included in the one or more test media.

10. A method for manufacturing a diagnostic testing system, comprising:

producing a diagnostic meter configured to measure the concentration of one or more analytes in a sample;

pre-calibrating the diagnostic meter using one set of predetermined calibration data;

producing a plurality of test media; and

selecting from the plurality of test media at least one test strip only if compatible with said one set of predetermined calibration data and thereby configured to accurately measure the concentration of one or more analytes using the diagnostic meter that has been pre-calibrated with the predetermined calibration data.

11. The method of claim 10, wherein the sample comprises body fluid.

12. The method of claim 11, wherein the sample is blood.

13. The method of claim 10, wherein the one or more analytes includes glucose.

14. The method of claim 10, wherein the sample includes a non-medical sample.

15. The method of claim 14, wherein the sample includes water.

16. The method of claim 10, wherein pre-calibrating the diagnostic meter includes configuring the test meter software to allow the meter to accurately measure the concentration of one or more analytes using the selected diagnostic test media.

17. The method of claim 10, wherein calibrating the diagnostic meter includes configuring the test meter hardware to allow the meter to measure the concentration of one or more analytes using the selected diagnostic test media.

18. The method of claim 10, further including configuring the diagnostic test meter to stop functioning after performing a number of diagnostic tests no less than the number of test media included in the one or more test media.

19. A method for manufacturing a diagnostic testing system, comprising:

producing a diagnostic meter configured to measure the concentration of one or more analytes in a sample;

pre-calibrating the diagnostic meter with one set of predetermined calibration data for each said analyte; and

producing one or more test media wherein all said test media are configured to accurately measure the concentration of one or more analytes using the diagnostic meter that has been pre-calibrated with the one set of predetermined calibration data.

20. The method of claim 19, wherein the sample comprises body fluid.

21. The method of claim 20, wherein the sample is blood.

22. The method of claim 19, wherein the sample includes a non-medical sample.

23. The method of claim 22, wherein the sample includes water.

24. The method of claim 19, wherein the one or more analytes includes glucose.

25. The method of claim 19, wherein pre-calibrating the diagnostic meter includes configuring the test meter software to allow the meter to measure the concentration of one or more analytes using the selected diagnostic test media.

26. The method of claim 19, wherein pre-calibrating the diagnostic meter includes configuring the test meter hardware to allow the meter to measure the concentration of one or more analytes using the selected diagnostic test media.

27. The method of claim 19, further including configuring the diagnostic test meter to stop functioning after performing a number of diagnostic tests no less than the number of test media included in the one or more test media.

28. A diagnostic testing system, comprising:

an enclosure;

a set of diagnostic test media which can be disposed within the enclosure; and

a diagnostic meter that can be physically coupled with the enclosure, wherein the diagnostic meter is configured to accurately measure the concentration of one or more analytes in a sample and is calibrated to accurately measure the concentration of the one or more analytes using at least one of diagnostic test strip included in the set of diagnostic test media.

29. The system of claim 28, further comprising a sampling device operably connected to the container.

30. The system of claim 29, wherein the sampling device comprises a lancet.

31. The system of claim 30, wherein the lancet comprises a spring for propelling the lancet to puncture the skin and the lancet is connected to the container such that a user can load the spring and release the spring to draw a sample without disconnecting the lancet from the container.

32. The system of claim 31, wherein the lancet comprises a mechanism for adjusting the depth of penetration of the lancet and the lancet is connected to the container and configured such that a user can operate the mechanism to adjust the depth of penetration of the lancet without disconnecting the lancet from the container.