NO CALIBRATION ANALYTE SENSORS AND METHODS

• US 20090011449A1
• Filed: 04/25/2008
• Published: 01/08/2009
• Est. Priority Date: 04/27/2007
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Wang, Yi, Karinka, Shridhara Alva
• Granted Patent: US 8,236,166 B2
• Time in Patent Office: Days
• US Class Current: 435/14
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A meter and sensors, for use in combination, where no calibration code has to be entered by the user or is read by the meter. The meter is configured with a predetermined slope and y-intercept built into the meter. If the slope and y-intercept of the sensor are within a predetermined area or grid, or otherwise close to the slope and y-intercept of the meter, the batch of sensors is acceptable for use with that meter for providing accurate analyte concentration results.

Claims

1. A meter for determining a concentration of an analyte in a sample applied to a sensor, the meter comprising:

a test port arranged and configured to receive the sensor; and

electronics arranged and configured to apply a first signal to the sensor and to detect a second signal from the sensor when the sensor is received by the test port, wherein the electronics are programmed to determine the concentration of the analyte based at least in part on the second signal, a single fixed slope value, and a single fixed intercept value, and wherein said sensors are from a plurality of lots.

2. The meter of claim 1, wherein the meter further comprises a sensor recognition means.

3. The meter of claim 2, wherein the sensor recognition means is arranged and configured to detect a turn on bar of the sensor.

4. The meter of claim 1, wherein the meter is programmed to determine the concentration of the analyte without receiving a calibration code associated with the sensor.

5. The meter of claim 1, wherein the meter is programmed to determine the concentration of the analyte without communication of a calibration code from the sensor.

6. A sensor for determining the concentration of an analyte, the sensor arranged and configured for insertion into a test port of a meter, the meter programmed to determine the concentration of the analyte based at least in part on the second signal, a single fixed slope value, and a single fixed intercept value, wherein the sensor has a slope value and an intercept value that are substantially equal to the single fixed slope value and the single fixed intercept value of the meter, wherein said sensor is one of a plurality of sensors from a plurality of lots.

7. The sensor of claim 6, further comprising a turn on bar.

8. A method of determining an analyte concentration in a sample, comprising:

providing a meter having a single defined slope value and single defined intercept value;

selecting a sensor from a plurality of sensor lots, said sensor having a slope value and an intercept value, wherein the slope value and the intercept value are equal to or substantially similar to the single defined slope and the single defined intercept;

inserting the sensor into the meter;

providing the sample to the sensor; and

determining the analyte concentration in the sample without communicating a calibration code to the meter.

9. The method of claim 8 wherein determining the analyte concentration in the sample without communicating the calibration code to the meter comprises determining the analyte concentration in the sample without the meter actively reading the calibration code.

10. The method of claim 8, wherein determining the analyte concentration in the sample without the meter actively reading the calibration code includes determining the analyte concentration in the sample without the meter actively reading the calibration code from the sensor or sensor package.

11. The method of claim 8, wherein selecting a sensor comprises selecting a sensor having a volume of no more than about 1 μ

L.

12. The method of claim 8, wherein selecting a sensor comprises selecting a sensor having a volume of no more than about 0.5 μ

L.

13. The method of claim 8, wherein selecting a sensor comprises selecting a sensor having a volume of no more than about 0.3 μ

L.

14. The method of claim 8, wherein selecting a sensor comprises selecting a sensor having a volume of no more than about 0.1 μ

L.

15. The method of claim 8, wherein selecting a sensor comprises selecting a tip-fill sensor.

16. The method of claim 8, wherein selecting a sensor comprises selecting a side-fill sensor.

17. The method of claim 8, wherein selecting a sensor comprises selecting a top-fill sensor.

18. The method of claim 8, wherein determining the analyte concentration in the sample comprises determining the concentration of analyte in the sample by coulometry.

19. The method of claim 8, wherein determining the analyte concentration in the sample comprises determining the concentration of analyte in the sample by amperometry.

20. The method of claim 8, wherein determining the analyte concentration in the sample comprises determining the concentration of analyte in the sample by potentiometry.

21. The method of claim 8, wherein determining the analyte concentration in the sample comprises determining a concentration of glucose in a sample of blood.