WO2009076244A1

WO2009076244A1 - Analyte cartridge with multi-function contacts

Info

Publication number: WO2009076244A1
Application number: PCT/US2008/085769
Authority: WO
Inventors: Qiang Fu; Amaresh Kumar
Original assignee: Bayer Healthcare Llc
Priority date: 2007-12-10
Filing date: 2008-12-06
Publication date: 2009-06-18

Abstract

A cartridge and method for using the cartridge with a testing device is adapted to determine information related to an analyte in a fluid sample. The cartridge comprises a sample-receiving area and at least one test strip containing a reagent for reacting with the analyte in the fluid sample. Also included in the cartridge is a module having a memory and three or less contacts adapted for communicating with the testing device. The three or less contacts may perform at least four functionalities relating to the operation of the testing device.

Description

{ PAGE } ANALYTE CARTRIDGE WITH MULTI-FUNCTION CONTACTS

FIELD OF THE INVENTION

[0001] The present invention generally relates to a cartridge. More specifically, the present invention generally relates to a cartridge to be used with testing devices or meters to determine an analyte concentration of a fluid.

BACKGROUND OF THE INVENTION

[0002] The quantitative determination of analytes in body fluids is of great importance in the diagnoses and maintenance of certain physiological abnormalities. For example, lactate, cholesterol, bilirubin, glucose and hemoglobin Al_c (or Al_c) should be monitored in certain individuals. In particular, it is important that individuals who are diabetic check the glucose and hemoglobin Al_c levels in their body fluids to regulate the glucose intake in their diets. The use of portable testing devices is a common way to test for such analytes. The results of such tests can be used to determine what, if any, insulin or other medication needs to be administered.

[0003] Cartridges are often used with portable testing devices to receive fluid (e.g., blood) from a user. The cartridge typically includes a top portion, a bottom portion, a sample-receiving area, a sensor strip and a chip or module containing a memory device and a plurality of contacts for electrically communicating with the testing device. Multiple electrical connections via multiple contacts may be made between the cartridge and the testing device to provide functions which allow the proper operation of the testing device. Such functions may assist with cartridge detection, calibration and other performance- enhancing features.

[0004] Even though multiple contacts may be necessary to properly operate the cartridge and testing device, many at-home users strongly desire the decreased size of testing materials (testing device, cartridges, lancing devices, etc.). Manufacturers also desire to reduce material costs associated with the testing devices and cartridges. Even a reduction in cost on the order of several cents, when multiplied by the large number of units (i.e., cartridges and testing devices) that are produced, results in substantial cost savings. Furthermore, the fewer the number of components required to operate the testing device and { PAGE \* MERGEFORMAT } cartridge, the more reliable the testing device and cartridge typically will be as there are less opportunities for components to malfunction, become damaged, wear out, etc.

[0005] Therefore, it would be desirable to have a cartridge and testing device that performs multiple functions while still maintaining a desired size for users and a minimum number of components for manufacturers.

SUMMARY OF THE INVENTION

[0006] In one embodiment, a cartridge is adapted to assist in determining information relating to an analyte in a fluid sample. The cartridge includes a sample- receiving area and at least one test strip containing a reagent for reacting with the analyte in the fluid sample. The cartridge further includes a module, the module including a memory and three or less contacts adapted for communicating with a testing device. The three or less contacts perform at least four functionalities relating to the operation of the testing device.

[0007] In another embodiment, a method of determining information related to an analyte of a fluid sample includes the acts of providing a cartridge having a sample-receiving area, at least one test strip and a module. The module includes a memory and three or less contacts for connecting to a testing device. The three or less contacts perform at least four functionalities relating to the operation of the testing device. The method also includes providing the testing device having an opening for receiving the cartridge and contacts for contacting the three or less contacts of the cartridge and placing the cartridge into the opening of the testing device and contacting the three or less contacts with respective contacts of the testing device. The method further includes performing at least one of the at least four functionalities relating to the operation of the testing device via the three or less contacts.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 is an exploded view of a cartridge according to one embodiment.

[0009] FIG. 2A is a top view of the cartridge of FIG. 1 according to one embodiment.

[0010] FIG. 2B is a bottom view of the cartridge of FIG. 1 according to one embodiment. { PAGE \* MERGEFORMAT }

[0011] FIG. 3 is a perspective view of a module or chip according to one embodiment.

[0012] FIG. 4 is an exploded view of a testing device used in connection with the cartridge of FIG. 1.

[0013] FIG. 5 is a perspective view of a module or chip according to another embodiment.

[0014] FIG. 6 is a perspective view of the module or chip of FIG. 5 in contact with the a portion of the testing device.

[0015] FIG. 7 is a graph illustrating a cartridge insertion signal according to one embodiment.

[0016] FIG. 8 is a graph illustrating a cartridge removal and authentication signal according to one embodiment.

[0017] FIG. 9 is a graph illustrating a sample detection signal of a cartridge according to one embodiment.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

[0018] The present invention is directed to an improved cartridge that is adapted to assist in determining information related to an analyte in a fluid (e.g., an analyte concentration). In one embodiment, a cartridge is configured to receive a fluid sample that is analyzed using a testing device or meter. Analytes that may be measured include glucose, lipid profiles (e.g., cholesterol, triglycerides, LDL and HDL), microalbumin, hemoglobin Al c, fructose, lactate, urea, creatinine, creatine, or bilirubin. It is contemplated that other analyte information may be determined using the cartridge of the present system, relating to, for example, enzymes and proteins such as alanine transaminase (ALT), alkaline phosphatase (ALP), gamma glutamyl transferase (GGT), aspartate transaminase (AST), transferrin and amylase, tumor markers such as alpha fetoprotein (AFP), alpha 1 -antitrypsin (AAT) and beta human chorionic gonadotrophin (bHCG), ions and trace metals such as calcium, copper, chloride, bicarbonate and zinc, hormones such as thyroid stimulating hormone (TSH), free thyroxine (FT4), free triiodothyronine (FT3), adrenocorticotropic hormone (ACTH), Cortisol, prolactin and testosterone, red blood cells such as hematocrit, mean cell volume (MCV), mean cell hemoglobin (MCH), red cell count, reticulocytes and erythrocyte sedimentation { PAGE \* MERGEFORMAT } rate (ESR), and white blood cells such as total white blood cells, neutrophil granulocytes, lymphocytes, monocytes, eosinophil granulocytes and basophile granulocytes. The analytes may be in, for example, a whole blood sample, a blood serum sample, a blood plasma sample, other body fluids like ISF (interstitial fluid) and urine, and non-body fluids.

[0019] In one embodiment, the cartridge 10 includes a top portion 12 and a bottom portion 14, as shown in FIG. 1, that are adapted to mate. The cartridge 10 includes a sample-receiving area 16 and one or more test strips or sensors 18 containing a reagent for reacting with the analyte of interest. In the example in FIG. 1, the cartridge 10 includes two test strips 18. The cartridge 10 further includes a sample pad 20 which is in fluid communication with the sample-receiving area 16 and the test strips 18 and may serve to distribute the sample between the one or more test strips 18. Adjacent to the sample pad 20 is a chip or module 30 that is adapted to communicate with a testing device or meter once the cartridge 10 is inserted into the testing device or meter. The chip or module may be associated with multiple functionalities to properly operate the testing device and is described in more detail below. It is further contemplated that additional components may be included in the cartridge 10, although not explicitly shown in the drawings and described herein. For example, electrodes, such as copper and zinc electrodes, may be included in the cartridge 10. The electrodes may create an electric potential when exposed to a fluid sample.

[0020] The top portion 12, the bottom portion 14 and the sample-receiving area 16 may be made from a variety of materials such as polymeric materials. Non- limiting examples of polymeric materials that may be used to form the top portion 12, the bottom portion 14 and the sample-receiving area 16 include polycarbonate, polyethylene terephthalate (PET), polyethylene naphthalate (PEN), polyimide and combinations thereof. It is contemplated that other materials, such as other non-conducting materials, may be used to form the top portion 12, the bottom portion 14 and the sample-receiving area 16.

[0021] The test strips or sensors 18 may be optical test strips or sensors. Optical test sensor systems may use techniques such as, for example, transmission spectroscopy, diffuse reflectance or fluorescence spectroscopy for measuring the analyte concentration. An indicator reagent system and an analyte in a sample of body fluid are reacted to produce a chromatic reaction — the reaction between the reagent and analyte causes the sample to change color. The degree of color change is indicative of the analyte concentration in the { PAGE \* MERGEFORMAT } body fluid. The color change of the sample is evaluated to measure the absorbance level of the transmitted light.

[0022] The chip or module 30 (shown in FIGS. 2B and 3) may contain a plurality of pins or contacts 32 that electrically connect with contacts on a meter or testing device when the cartridge is inserted into an opening in a meter or testing device. In one embodiment, the chip or module 30 contains three or less contacts 32. In the embodiments shown in FIG. 2B and 3, for example, the chip or module 30 contains two contacts 32a,b. The two contacts 32a,b are shown as being polygonal shapes and, more specifically, a generally rectangular or square shape. It is contemplated that the polygonal shapes may be other polygonal shapes and other non-polygonal shapes. Furthermore, the contacts 32 are typically of the same shape and size, but it is contemplated that the test-sensor contacts may be of different shapes and/or sizes. It is also contemplated that, in other embodiments, more or less than two contacts may be included with the chip 30.

[0023] FIGS. 2A and 2B depict top and bottom views of the cartridge 10, respectively. In FIG. 2B, a cutaway portion of the cartridge 10 is shown exposing the chip 30 that is contained in the cartridge 10. In this embodiment, the chip 30 is shown having two contacts 32a,b. These contacts 32a,b are adapted to make contact with the one or more contacts of the meter or testing device, as shown in FIG. 3. As shown here, direct mechanical contacts may be made between contacts on the chip 30 and contacts on the testing device. In other embodiments described herein, the chip 30 may have one or more contacts on opposing sides of the chip 30 and contact with the testing device may occur through those contacts.

[0024] The contacts 32a,b may be associated with features of the testing device which will be described in more detail below. In some embodiments, the contacts 32a,b may be part of a printed circuit board, a flex cable, or may be integrated as part of the electrical package. The contacts 32a,b may be comprised of conductive materials, such as copper, zinc, platinum, and other conducting materials.

[0025] The chip 30 may also include a memory device 34 (see FIG. 5) for storing data relating to the operation of the chip 30 and test sensors 18. The data or information may include reagent-dependent calibration information, a lot number, a checksum, a serial number, the cartridge type (i.e., internal testing, lab testing, etc.), authentication data, a reagent expiration date, used cartridge information, and other similar types of data or { PAGE \* MERGEFORMAT } information. One type of memory device 34 may be a memory chip. Some examples of a memory chip include EEPROM and EPROM chips, such as DS2502, DS2433 and DS2431 which are available from Maxim Integrated Products, Inc. of Sunnyvale, California. These chips are available as SFN (single (line of contact), flat, no leads) packages or SOIC (small outline integrated circuit) packages. In addition to a memory chip, the memory device may be any data storage device known in the art.

[0026] As mentioned above, the contacts 32 are designed to make contact with the contacts of a testing device or meter. A testing device or meter 50 that may be used with the cartridge 10 described herein is shown in an exploded view in FIG. 4. The testing device 50 includes an upper housing 52 and a lower housing 54 that are adapted to mate to assist in protecting the components of the testing device 50. The upper housing 52 includes a display area 56 where testing results and information about the testing device 50 or cartridge 10 may be displayed to a user via an LCD display 58 or other similar device. Some of the information that may be displayed to a user includes analyte-concentration readings, time and date indicators, markers, alarms and any combinations thereof. It is contemplated that other information may be displayed. The display may also include different types of displays, for example, a graphics display, a plasma display, a backlit display, a combination segmented/graphic display or any other suitable display.

[0027] A cutout portion 60 in the upper housing 52 corresponds to the sample- receiving area 16 of the cartridge 10 such that, once the cartridge 10 is inserted into the testing device 50, the sample-receiving area 16 remains exposed to receive a fluid sample. Although not shown in FIG. 4, a user-input mechanism may also be included to allow the user to make selections relating to one or more user features of the testing device 50. The user-input mechanism may include, for example, buttons, scroll bars, touch screens, or any combination of such items. Furthermore, a processor (also not shown) may be included to store analyte concentration readings, calibration information, etc. The processor may also process information and communicate with the memory device 34 in the cartridge 10. The testing device 50 may further include a data port (not shown) that is adapted to communicate with a remote device (e.g., a computer) via a communications link. The communications link may be a wired system or wireless. { PAGE \* MERGEFORMAT }

[0028] An ESD shield 62 is located below the upper housing 52. The ESD shield 62 protects the components of the testing device 50 from electrostatic discharges. An optics assembly 64 is located below the ESD shield 62 and is configured to transmit illumination toward the test strips 18 to assist in the optical analysis of the fluid sample for the analyte of interest. The optics assembly 64 includes at least one lens and a detector. Also included is one or more batteries 66 and a connector 68 that connects to the LCD 58. The connector 68 is sandwiched between a rubber strip, such as a zebra strip, which allows for the alignment of items on a printed circuit board (PCB) 72.

[0029] A light shield 70 positioned adjacent the optics assembly 66 prevents or inhibits stray radiation from entering the detectors. The printed circuit board 72 is positioned below the light shield 70. Attached to the PCB 72 are meter contacts 73. The meter contacts 73 make contact with the contacts 32 of the cartridge 10 to provide information for operating the testing device 10. The testing device 50 is shown as containing at least two contacts that are side-mounted to the PCB 72; however, more or fewer meter contacts 73 may be included in the testing device 50. The shape of the meter contacts 73 may be of a generally angled or crescent shape, although it is contemplated that the meter contacts 73 may be of other shapes and sizes than those depicted in FIG. 4. It is also contemplated that the meter contacts 73 may be located in different locations on the PCB 72 such that the meter contacts 73 are available to make contact with the contacts 32 of the cartridge 10.

[0030] FIG. 5 illustrates another embodiment of the present invention wherein the chip or module 30 includes the memory device 34 and contacts 32a,b connected to a PCB 36. The PCB 36 may also contain contacts 38a,b, which may include, for example, sample- detection contacts. Contacts 38a,b may be internally shorted or connected with the contacts 32a,b on the chip or module 30 via a copper trace for example. For example, contact 32a may be connected with contact 38a and contact 32b may be connected with contact 38b. This results in a circuit wherein when contact 38a is contacted with a meter contact 73, contact 32a is also contacted. Similarly, when contact 38b is contacted with a meter contact 73, contact 32b is also contacted. Thus contact 32a is electrically the same as contact 38a, and contact 32b is electrically the same as contact 38b. Furthermore, the PCB 36 may also include additional contacts that may be internally shorted or connected with contacts 38a,b. For example, contacts 38a,b may be connected with contacts located on a bottom portion of the { PAGE \* MERGEFORMAT }

PCB 36, shown by dotted lines as 40a,b. The additional contacts 40a,b may include, for example, meter detection contacts, which may be internally connected to top contacts 38a,b (sample detection contacts), which in turn are connected to chip contacts 32a,b. This results in a circuit wherein contacts 32a, 38a and 40a are electrically the same contact and contacts 32b, 38b and 40b are electrically the same contact.

[0031] FIG. 6 illustrates a perspective view of the chip 30 once it is inserted into a testing device. The contacts 40a,b (on the bottom portion of the chip 30) are in contact with meter contacts 73 which are attached to the PCB 72 of the testing device 50. As described in more detail below, the contact between the contacts 32, 38 and 40 of the chip 30 and the contacts 73 of the testing device 50 allow the testing device 50 to obtain certain information regarding the testing device 50 and the cartridge 10 including the insertion or removal of the cartridge, the detection of a fluid sample, the authentication of the cartridge, etc.

[0032] Specifically, the contacts 32, 38 and 40 (hereinafter referred to collectively as "32") of the cartridge 10 as described herein allow the testing device 10 to perform several functionalities associated with the operation of the testing device 50. In some embodiments, the functionalities include (1) detecting the insertion of the cartridge 10 into the testing device 50, (2) detecting the removal of the cartridge 10 from the testing device 50, (3) detecting the presence of a sample in the testing device 50, (4) detecting the insertion of a used cartridge into the testing device 50, (5) authenticating the cartridge 10, and (6) implementing the no- coding feature of the cartridge 10. The cartridge 10 as described herein performs such functionalities using three or less contacts 32. In one embodiment, the cartridge 10 performs these functionalities using two contacts 32.

[0033] The ability to perform all of the functionalities described herein using two contacts 32 is advantageous as the fewer the number of contacts, the more reliable the testing device 50. This is due to the lower occurrences of contacts malfunctioning, become damaged or wearing out. Additionally, a substantial reduction in the cost to manufacture the cartridges is realized due to the reduced number of contacts that are required in the cartridge.

[0034] Prior devices typically included several contacts, each associated with a single, different functionality. By contrast, according to the present invention, both contacts 32a and 32b are associated with multiple functionalities. For example, contact 32a and 32b may be associated with detecting the insertion and removal of the cartridge, the { PAGE \* MERGEFORMAT } authentication of the cartridge 10 and the implementation of the no-coding feature of the cartridge 10. Other combinations regarding the contacts and functionalities are contemplated and may be used in accordance with the concepts described herein.

[0035] For the testing device 50 to begin operation, the testing device 50 must proceed through several states which correlate to the functionalities described herein. The states include "waking up" the processor, authenticating the cartridge, detecting a fluid sample, providing the correct calibration information and, then performing the testing for the analyte. Under certain conditions, other states may include detecting the removal of the cartridge or detecting a used cartridge. These states correlate with the different functionalities described herein.

[0036] For the functionality associated with the detection of the insertion of the cartridge 10 into the testing device 50, one of the two contacts 32 provides a signal which goes from a high voltage, i.e., about 3 volts, to a low voltage, i.e., about 0 volts, as shown in FIG. 7. This change in voltage in effect "wakes up" the processor of the testing device 50, which then proceeds to perform an authentication of the cartridge 50.

[0037] For authentication of the cartridge 10, the processor of the testing device 50 performs different levels of authentication. Once the cartridge 10 passes the authentication process, the testing device 10 proceeds with the testing procedure. As an initial authentication sequence, the processor of the testing device 50 sends out a reset pulse (i.e., "tRTSL") to detect a cartridge presence pulse (i.e., "tpoi/'X as shown in FIG. 8. In a second level of authentication, the processor of the testing device 50 authenticates the serial number of the memory device 34 on the cartridge 10, as each memory device 34 has a unique, factory-programmed registration number. A third level of authentication includes the authentication of a manufacturer's digital signature that is located in a particular location in the memory device 34. In some embodiments, one or more of these levels (e.g., level three) may not always be performed.

[0038] For the functionality associated with the detection of the fluid sample, one of the two contacts produces a signal that changes from a high signal to a low signal, as shown in FIG. 9. This sends an interrupt signal to the processor of the testing device 50 and the processor begin the testing process. Once the fluid sample is added to the cartridge 10, the fluid sample flows to the sensor strips 18 and reacts with the reagent and produces a color { PAGE \* MERGEFORMAT } change that is detected by the optics system. Once the testing process is concluded, the testing device 50 performs the digital signal processing to generate the final result which may be displayed to the user and/or saved in memory in the testing device 50.

[0039] The detection of the removal of the cartridge 10 is related to the authentication process described above and shown in FIG. 8. When detecting the removal of the cartridge 10 from the testing device 50 before a fluid sample is received, the processor of the testing device 50 sends out a reset pulse to detect a cartridge presence pulse. If the cartridge 10 has been removed from the testing device 10, then a cartridge presence pulse will not be sent, thus indicating that the cartridge 10 has been removed. When detecting the removal of the cartridge 10 after a fluid sample is added to the cartridge 10, one of the processor pins which makes contact with one of the contacts 32 is able to detect signal logic high and signal logic low which indicates that the cartridge 10 has been removed.

[0040] For the functionality associated with the detection of a used cartridge, once a cartridge 10 is inserted into the testing device 50, the cartridge 10 is marked as "used" by writing to a particular memory location in the memory device 34. Thus, if a user inserts a used cartridge, the testing device 10 may display a message that the cartridge is not valid and/or may simply refrain from performing the test until a new cartridge is inserted.

[0041] For the functionality associated with the no-coding implementation, each cartridge 10 stores reagent-dependent data in the memory device 34 of the cartridge 10. Once the cartridge 10 is inserted into the testing device 50, the testing device 10 downloads the data from the memory device 34. This process thus does not require that a user manually input calibration information into the testing device 50. In one example, the downloaded data may used for testing a fluid sample for the Al_c concentration via an Al_c algorithm stored in the testing device 50.

[0042] All of the functionalities described herein are performed by three or less contacts, and preferably two contacts. Also, with the no-coding implementation, the cartridge may be used with multiple testing devices as the information specific to each cartridge is stored on the cartridge and not any on a particular testing device. Some commercially available instruments or meters, such as those that are manufactured and/or sold by Bayer Healthcare LLC of Tarrytown, New York, may be designed to incorporate the features of the present invention, such as the Metrika AlCNOW⁺. It is contemplated that other instruments { PAGE \* MERGEFORMAT } or meters, in addition to the ones listed above, may be designed to incorporate the features of the present invention. It is also contemplated that the testing device, cartridge and chip may be of a different shape or size than those depicted in Figures 1-6.

EMBODIMENT A

[0043] A cartridge adapted to assist in determining information relating to an analyte in a fluid sample, the cartridge comprising: a sample-receiving area and at least one test strip containing a reagent for reacting with the analyte in the fluid sample; and a module, the module including a memory and three or less contacts adapted for communicating with a testing device, wherein the three or less contacts perform at least four functionalities relating to the operation of the testing device. EMBODIMENT B

[0044] The cartridge of embodiment A wherein the module includes two contacts for performing four functionalities relating to the operation of the testing device. EMBODIMENT C

[0045] The cartridge of embodiment A wherein one of the at least four functionalities is associated with detecting the insertion of the cartridge into the testing device. EMBODIMENT D

[0046] The cartridge of embodiment A wherein one of the at least four functionalities is associated with detecting the removal of the cartridge from the testing device. EMBODIMENT E

[0047] The cartridge of embodiment A wherein one of the at least four functionalities is associated with detecting the presence of a sample fluid in the cartridge. EMBODIMENT F

[0048] The cartridge of embodiment A wherein one of the at least four functionalities is associated with authentication of the cartridge. { PAGE \* MERGEFORMAT } EMBODIMENT G

[0049] The cartridge of embodiment A wherein one of the at least four functionalities is associated with detecting a used cartridge. EMBODIMENT H

[0050] The cartridge of embodiment A wherein one of the at least four functionalities is associated implementing a no-coding function. EMBODIMENT I

[0051] The cartridge of embodiment A wherein one or more contacts is a printed circuit board, a flex cable or an integrated chip. EMBODIMENT J

[0052] The cartridge of embodiment A wherein at least two contacts are on opposing sides of the module. EMBODIMENT K

[0053] The cartridge of embodiment A wherein the analyte is glucose, cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, microalbumin, hemoglobin Al c, fructose, lactate, urea, creatinine, creatine, or bilirubin. PROCESS L

[0054] A method of determining information related to an analyte of a fluid sample, the method comprising the acts of: providing a cartridge having a sample-receiving area, at least one test strip and a module, the module including a memory and three or less contacts for connecting to a testing device, wherein the three or less contacts perform at least four functionalities relating to the operation of the testing device; providing the testing device having an opening for receiving the cartridge and contacts for contacting the three or less contacts of the cartridge; placing the cartridge into the opening of the testing device and contacting the three or less contacts with respective contacts of the testing device; and performing at least one of the at least four functionalities relating to the operation of the testing device via the three or less contacts. { PAGE \* MERGEFORMAT }

PROCESS M

[0055] The method of process L wherein the performing includes detecting the insertion of the cartridge into the testing device via the three or less contacts. PROCESS N

[0056] The method of process L wherein the performing includes detecting the removal of the cartridge from the testing device via the three or less contacts. PROCESS O

[0057] The method of process L wherein the performing includes detecting the presence of a fluid sample via the three or less contacts. PROCESS P

[0058] The method of process L wherein the performing includes authenticating the cartridge via the three or less contacts. PROCESS O

[0059] The method of process L wherein the performing includes detecting a used cartridge via the three or less contacts. PROCESS R

[0060] The method of process L wherein the cartridge includes two contacts to perform the at least four functionalities. PROCESS S

[0061] The method of process L wherein the analyte is glucose, cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, microalbumin, hemoglobin Al c, fructose, lactate, urea, creatinine, creatine, or bilirubin.

[0062] While the present invention has been described with reference to one or more particular embodiments, those skilled in the art will recognize that many changes may be made thereto without departing from the spirit and scope of the present invention. Each of these embodiments, and obvious variations thereof, is contemplated as falling within the spirit and scope of the invention.

Claims

{ PAGE \* MERGEFORMAT } WHAT IS CLAIMED IS:

1. A cartridge adapted to assist in determining information relating to an analyte in a fluid sample, the cartridge comprising: a sample-receiving area and at least one test strip containing a reagent for reacting with the analyte in the fluid sample; and a module, the module including a memory and three or less contacts adapted for communicating with a testing device, wherein the three or less contacts perform at least four functionalities relating to the operation of the testing device.

2. The cartridge of claim 1, wherein the module includes two contacts for performing four functionalities relating to the operation of the testing device.

3. The cartridge of claim 1, wherein one of the at least four functionalities is associated with detecting the insertion of the cartridge into the testing device.

4. The cartridge of claim 1, wherein one of the at least four functionalities is associated with detecting the removal of the cartridge from the testing device.

5. The cartridge of claim 1, wherein one of the at least four functionalities is associated with detecting the presence of a sample fluid in the cartridge.

6. The cartridge of claim 1, wherein one of the at least four functionalities is associated with authentication of the cartridge.

7. The cartridge of claim 1, wherein one of the at least four functionalities is associated with detecting a used cartridge.

8. The cartridge of claim 1, wherein one of the at least four functionalities is associated implementing a no-coding function.

9. The cartridge of claim 1, wherein one or more contacts is a printed circuit board, a flex cable or an integrated chip.

10. The cartridge of claim 1, wherein at least two contacts are on opposing sides of the module.

11. The cartridge of claim 1, wherein the analyte is glucose, cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, microalbumin, hemoglobin Al c, fructose, lactate, urea, creatinine, creatine, or bilirubin.

12. A method of determining information related to an analyte of a fluid sample, the method comprising the acts of: { PAGE \* MERGEFORMAT } providing a cartridge having a sample-receiving area, at least one test strip and a module, the module including a memory and three or less contacts for connecting to a testing device, wherein the three or less contacts perform at least four functionalities relating to the operation of the testing device; providing the testing device having an opening for receiving the cartridge and contacts for contacting the three or less contacts of the cartridge; placing the cartridge into the opening of the testing device and contacting the three or less contacts with respective contacts of the testing device; and performing at least one of the at least four functionalities relating to the operation of the testing device via the three or less contacts.

13. The method of claim 12, wherein the performing includes detecting the insertion of the cartridge into the testing device via the three or less contacts.

14. The method of claim 12, wherein the performing includes detecting the removal of the cartridge from the testing device via the three or less contacts.

15. The method of claim 12, wherein the performing includes detecting the presence of a fluid sample via the three or less contacts.

16. The method of claim 12, wherein the performing includes authenticating the cartridge via the three or less contacts.

17. The method of claim 12, wherein the performing includes detecting a used cartridge via the three or less contacts.

18. The method of claim 12, wherein the cartridge includes two contacts to perform the at least four functionalities.

19. The method of claim 12, wherein the analyte is glucose, cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein, microalbumin, hemoglobin Al c, fructose, lactate, urea, creatinine, creatine, or bilirubin.