Method for determining a test strip calibration code for use in a meter

• US 7,593,097 B2
• Filed: 05/26/2006
• Issued: 09/22/2009
• Est. Priority Date: 05/26/2006
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson), LifeScan IP Holdings, LLC
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: McInulty, John, Baskeyfield, Damian Edward Haydon, Robinson, Grenville Arthur, Cronshaw, Anthony J., O'Reilly, Thomas J.
• Primary Examiner(s): PUNNOOSE, ROY M
• Application Number:
  US11/441,946
• Publication Number:
  US 20070273904A1
• Time in Patent Office: 1,215 Days
• Field of Search: 356/42, 356/243.4, 356/244, 356/243.1, 422/55, 422/56, 422/57
• US Class Current: 356/42
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A method for determining a test strip calibration code for use in a meter includes inserting a test strip into the meter. The inserted test strip having a substrate with a working surface for receiving the body fluid sample and a reverse surface that is in opposition to the working surface. The test strip also includes a permutative grey scale calibration pattern disposed on either of the working and reverse surfaces, with the permutative grey scale calibration pattern including more than one grey scale region. Moreover, the scale regions of the test strip define a grey scale permutation that uniquely corresponds to a calibration code of the test strip. The method also includes detecting the permutative grey scale calibration pattern with a grey scale photodetector module of the meter and determining a calibration code that uniquely corresponds to a grey scale permutation defined by the permutative grey scale calibration pattern based on permutation matrix stored in the meter.

Claims

1. A method for determining a test strip calibration code for use in a meter, the method comprising:

inserting a test strip into the meter, the test strip having;

a substrate, the substrate having;

a working surface for receiving the body fluid sample; and

a reverse surface that is in opposition to the working surface; and

a permutative grey scale calibration pattern disposed on at least one of the working surface and reverse surface, the permutative grey scale calibration pattern including at least a first grey scale region and a second grey scale region, wherein the first and second grey scale regions define a grey scale permutation that uniquely corresponds to a calibration code of the test strip;

detecting the permutative grey scale calibration pattern with a grey scale photodetector module of the meter; and

determining a calibration code that uniquely corresponds to a grey scale permutation defined by the permutative grey scale calibration pattern based on a permutation matrix stored in the meter.

2. The method of claim 1 wherein the inserting step includes inserting a test strip wherein the permutative grey scale pattern is disposed on the reverse surface.

3. The method of claim 1 wherein the permutative grey scale calibration pattern includes two grey scale regions.

4. The method of claim 1 wherein the permutative grey scale calibration pattern includes a first grey scale region, a second grey scale region and a third grey scale region.

5. The method of claim 1 wherein the grey scale calibration pattern further includes at least one optics calibration region.

6. The method of claim 5 wherein the at least one optics calibration region has a black optics calibration region and a white optics calibration region.

7. The method of claim 6, wherein the at least one optics calibration region further has a 50% grey scale optics calibration region.

8. The method of claim 6 wherein the at least one optics calibration region further has a 25% grey scale optics calibration region and a 75% grey scale optics calibration region.

9. The method of claim 1 wherein the test strip is an electrochemical test strip.

10. The method of claim 9 wherein the test strip is configured for the determination of glucose in a whole blood sample.

11. The method of claim 1 wherein the test strip is a photometric test strip.

12. The method of claim 11 wherein the test strip is configured for the determination of glucose in a whole blood sample.

13. The method of claim 1 wherein the detecting step occurs during the inserting step.

14. The method of claim 1 wherein the detecting step occurs after the inserting step has been completed.

15. The method of claim 1 wherein the detecting step occurs as the test strip is being removed from the meter.