MEMORY APPARATUS FOR MULTIUSE ANALYTE TEST ELEMENT SYSTEMS, AND KITS, SYSTEMS, COMBINATIONS AND METHODS RELATING TO SAME

• US 20110151571A1
• Filed: 12/23/2009
• Published: 06/23/2011
• Est. Priority Date: 12/23/2009
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Wooldridge, Scott
• Application Number:
  US12/645,520
• Publication Number:
  US 20110151571A1
• Time in Patent Office: Days
• US Class Current: 436/95
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

One embodiment includes a memory unit for use in connection with a plurality of fluid sample test elements, wherein the memory unit comprises a plurality of memory portions. In one aspect of the embodiment, the memory unit comprises at least one memory portion configured to communicate calibration and expiration information relating to a lot of test elements, to a meter operably connectable with such test elements, and at least one other memory portion configured for storage and communication of data, such as measurement results, relating to the use of the test elements in analyzing a fluid sample. Further embodiments include apparatuses, systems, methods, kits and combinations of test elements and memory units.

Claims

1. A kit comprising:

a plurality of test elements including a region configured to receive a sample of fluid and a reagent adapted to react with the sample of fluid; and

a memory unit having a first set of memory locations and a second set of memory locations, the first set of memory locations storing calibration information relating to the plurality of test elements, wherein the stored calibration information is encrypted;

wherein the memory unit is insertable by a user into a meter effective to provide the meter access to the first set of memory locations and the second set of memory locations.

2. A kit according to claim 1 wherein the first set of memory locations is configured to store encrypted calibration information relating to the plurality of test elements, and the second set of memory locations is password protected.

3. A kit according to claim 1 wherein the memory unit includes a third set of memory locations storing audio content, gaming content, video content, visual content, or a combination thereof.

4. A kit according to claim 1 wherein the test elements are blood glucose test strips and the reagent is operable to react with the sample to provide information indicative of blood glucose concentration.

5. A kit according to claim 1 wherein the memory unit includes flash memory.

6. A kit according to claim 1 wherein the test elements and the memory unit are provided in common packaging.

7. A kit according to claim 1 further comprising a meter operable to communicate with the test elements and the memory unit.

8. A kit according to claim 7 wherein the first set of memory locations stores encrypted computer code and the meter is operable to decrypt the calibration information, decrypt the computer code, and analyze the sample using the decrypted calibration information and the decrypted computer code.

9. A kit according to claim 7 wherein the meter is operable to store password protected information of a measurement of the sample in the second set of memory locations.

10. A kit according to claim 1 wherein the first set of memory locations includes hidden memory locations.

11. A kit according to claim 3 wherein the first set of memory locations, the second set of memory locations and the third set of memory locations are partitions of a common memory.

12. A kit according to claim 1 wherein the second set of memory locations is password protected.

13. A kit according to claim 1 wherein the first set of memory locations and the second set of memory locations are provided with a security feature.

39. A kit according to claim 1 wherein the encrypted calibration information is stored in a hidden memory location.

40. A kit according to claim 1 wherein DRM protected content is stored in the second set of memory locations.

41. A kit according to claim 1 wherein the encrypted calibration information is hardware-level encrypted.

42. A kit according to claim 1 wherein the encrypted calibration information is provided to an external user or device based upon a request and credential verification process.

43. A kit according to claim 1 wherein the calibration information is encrypted using a block cipher, stream cipher, cryptographic hash function, message authentication code, digital signature, Data Encryption Standard (DES) encryption, triple-DES encryption, Advanced Encryption Standard (“

AES”

) encryption, public-key encryption, Diffie-Hellman encryption, RSA encryption, elliptic curve encryption, PGP encryption, El Gamal encryption or a combination thereof.

44. A kit according to claim 1 wherein the first set of memory locations and the second set of memory locations are provided with different security features.

14-33. -33. (canceled)

34. A kit comprising:

a plurality of test elements each being combinable with a meter to measure a glucose concentration of a sample of biological fluid provided to a respective test element;

a memory unit having a first set of memory locations and a second set of memory locations, the first set of memory locations storing calibration information relating to the plurality of test elements, the calibration information being encrypted;

wherein the memory unit is physically connectable to the meter to provide the meter access to the calibration information protected with a security feature.

35. A kit according to claim 34 wherein the meter is operable to store a plurality of glucose concentration measurements in the second set of memory locations, the plurality of glucose concentration measurements being protected with a second security feature.

36. A kit according to claim 35 wherein memory unit includes a third set of memory locations and the meter and the memory unit are operable to control user access to the third set of memory locations based upon a number of glucose concentration measurements in the second set of memory locations.

37. A kit according to claim 34 wherein the calibration information relating to the plurality of test elements stored the first set of memory locations is encrypted.

38. A kit according to claim 35 wherein the plurality of glucose concentration measurements stored the second set of memory locations are encrypted.