Analyte detection devices and methods with hematocrit/volume correction and feedback control

1. An arrangement for measuring a concentration of an analyte contained in a sample of body fluid, the arrangement comprising:

an assay pad containing a single chemical reagent, wherein the chemical reagent produces a detectable signal in the form of a color change at a reaction spot formed upon reaction with the analyte, and wherein the concentration of the analyte is measured at the reaction spot;

a light source;

a detector array; and

a processor configured to:

derive a hematocrit level value from the color change at the reaction spot; and

calculate a hematocrit-adjusted analyte concentration using the hematocrit level value.

2. The arrangement of claim 1 , wherein the analyte comprises glucose and the body fluid comprises blood.

3. The arrangement of claim 1 , wherein the detector array is a linear array.

4. The arrangement of claim 1 , wherein the detector array comprises at least one of a linear array, a polar array, and an area array.

5. The arrangement of claim 1 , wherein the detector array comprises a plurality of detector elements, the detector elements comprising CMOS, CCD, photodiode, infrared, fluorescent, or ultraviolet elements.

6. The arrangement of claim 1 , further comprising at least one body fluid sampling catalyst device.

7. The arrangement of claim 6 , wherein the at least one catalyst device comprises at least one of a vacuum pump, a vibration motor, and a heating element.

8. The arrangement of claim 7 , wherein the at least one catalyst device is configured to be responsive to control signals, the control signals based on sample volume calculations.

9. The arrangement of claim 5 , wherein at least a portion of the plurality of detector elements are not in optical registry with the reaction spot and are configured to analyze one or more of a control solution having a known concentration of analyte introduced onto an area of the assay pad that is different from the area of the reaction spot, a standard color producing a known signal, and calibration information specific to the lot of the assay pad.

10. The arrangement of claim 1 further comprising a memory, wherein the processor is further configured to look-up the hematocrit level value in a look-up table stored on the memory.

11. The arrangement of claim 1 , further comprising a needle having a first end configured to pierce skin, and a second end in fluid communication with the assay pad.

12. An analyte monitoring device comprising the arrangement of claim 1 , wherein the arrangement comprises a plurality of assay pads and a plurality of needles, thereby enabling the performance of a plurality of analyte concentration measurements.

13. The analyte monitoring device of claim 12 , further comprising a band for attaching the device to a body of a user.

14. An integrated meter comprising:

at least one piercing element;

at least one actuation member; and

the arrangement of claim 1 .

15. An arrangement for measuring a concentration of an analyte contained in a sample of body fluid, the arrangement comprising:

an assay pad comprising a chemical reagent configured to produce a detectable color change in a reaction with the analyte, wherein the detectable color change is indicative of an analyte level;

a light source;

a detector array; and

a processor configured to:

derive a calibration factor from the detectable color change of the same reaction, wherein the calibration factor is indicative of the level of hematocrit contained in the sample; and

calculate the concentration of the analyte using the analyte level and the calibration factor.

16. The arrangement of claim 15 , wherein the analyte comprises glucose and the body fluid comprises blood.

17. The arrangement of claim 15 , wherein the detector array is a linear array.

18. The arrangement of claim 15 , wherein the detector array comprises at least one of a linear array, a polar array, and an area array.

19. The arrangement of claim 15 , wherein the detector array comprises a plurality of detector elements, the detector elements comprising CMOS, CCD, photodiode, infrared, fluorescent, or ultraviolet elements.

20. The arrangement of claim 15 , further comprising at least one body fluid sampling catalyst device.

21. The arrangement of claim 20 , wherein the at least one catalyst device comprises at least one of a vacuum pump, a vibration motor, and a heating element.

22. The arrangement of claim 21 , wherein the at least one catalyst device is configured to be responsive to control signals, the control signals based on sample volume calculations.

23. The arrangement of claim 19 , wherein at least a portion of the plurality of detector elements are not in optical registry with a reaction spot formed by the reaction and are configured to analyze one or more of a control solution having a known concentration of analyte introduced onto an area of the assay pad that is different from the area of the reaction spot, a standard color producing a known signal, and calibration information specific to the lot of the assay pad.

24. The arrangement of claim 15 further comprising a memory, wherein the processor is further configured to look-up the calibration factor in a look-up table stored on the memory.

25. The arrangement of claim 15 , further comprising a needle having a first end configured to pierce skin, and a second end in fluid communication with the assay pad.

26. An analyte monitoring device comprising the arrangement of claim 15 , wherein the arrangement comprises a plurality of assay pads and a plurality of needles, thereby enabling the performance of a plurality of analyte concentration measurements.

27. The analyte monitoring device of claim 26 , further comprising a band for attaching the device to a body of a user.

28. An integrated meter comprising:

at least one piercing element;

at least one actuation member; and

the arrangement of claim 15 .