GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020

K022545 · Hypoguard USA, Inc. · NBW · Oct 11, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022545
• Device Name: GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020
• Applicant: Hypoguard USA, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

GlucoBalance™ Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

Device Story

Device consists of data transfer cable and software; accessory for Hypoguard blood glucose meters. Transfers glucose test results from meter memory to computer; maintains history of results; converts data into graphs, charts, and reports. Used in home and clinical settings by patients and healthcare professionals. Software does not recommend medical treatment or medication dosage. Output used by providers and patients to review historical trends and support diabetes management decisions.

Clinical Evidence

Bench testing only. Included validation of hardware (data transfer cable) and software functional characteristics. Consumer studies conducted to demonstrate ease of operation for in-home users.

Technological Characteristics

Consists of a data transfer cable and software application. Operates as an accessory to Hypoguard blood glucose meters. Connectivity via cable for data download to a computer. Software provides data management, visualization (graphs/charts), and reporting. No medical treatment or dosage recommendations provided.

Indications for Use

Indicated for people with diabetes and their healthcare professionals in home and clinical settings to assist in the review, analysis, and evaluation of historical blood glucose test results to support diabetes management.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Camit Data Management System from Roche Diagnostics Corp. (K001907)

Submission Summary (Full Text)

{0}------------------------------------------------

K02254/5
OCT 11 2002

# SECTION 2. SUMMARY AND CERTIFICATION

| A. 510(k) Summary | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Hypoguard USA, Inc. |
| Contact Person: | Bruce A. MacFarlane, Ph.D.,<br>Vice President, Regulatory Affairs and Quality Systems<br>Hypoguard USA, Inc.<br>5182 West 76th Street,<br>Minneapolis, MN 55439<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | July 31, 2002 |
| Trade Name: | GlucoBalance Data Management Software |
| Classification Name<br>and Number: | Glucose Test System, Class II, 21 CFR 862.1345 |
| | Calculator/Data Processing Module, Class I, 21 CFR 862.2100 |
| Product Codes: | CGA, NBW and JQP |
| Predicate Device(s): | Camit Data Management System from Roche Diagnostics Corp.<br>(K001907). |
| Device Description | The GlucoBalance Data Management Software is an optional<br>accessory for use with Hypoguard blood glucose meters with data<br>management capabilities. The subject device consists of a data<br>transfer cable and software. The system allows the user to<br>download blood glucose results from their glucose meter to their<br>computer, maintain a history of their glucose test results, and<br>convert them into graphs, charts and reports. It should be noted<br>that the software does not recommend any medical treatment or<br>medication dosage level. |
| Intended Use: | Intended Use: GlucoBalance™ Data Management Software is an<br>optional accessory for use with Hypoguard blood glucose meters<br>with data management capabilities. GlucoBalance transfers data<br>from the meter's memory into a computer for enhanced data<br>management. GlucoBalance is intended for use in home and<br>clinical settings to assist people with diabetes and their health care |

{1}------------------------------------------------

professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

### Functional and Representative samples of the subject device underwent Safety Testing: performance testing to demonstrate appropriate functional characteristics. The testing included validation of the systems hardware (the data transfer cable) and software as well as consumer studies that demonstrated the systems ability to be easily operated by in-home users.

Conclusion: The GlucoBalance Data Management Software is substantially equivalent to the Camit Data Management System from Roche Diagnostics Corp. (K001907).

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bruce A. Mac Farlane, Ph.D. Vice President Regulatory Affaris and Quality Systems Hypoguard USA, Inc. 5182 West 76th Street Minneapolis, MN 55439

OCT 11 2002

k022545 Re:

> Trade/Device Name: GlucoBalance Data Management Software Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: July 31, 2002 Received: August 1, 2002

Dear Dr. MacFarlane:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Indications For Use Page

510(k) Number (if known): K022545

Device Name: GlucoBalance Data Management Software

Indications for Use:

Intended Use: GlucoBalance™ Data Management Software is an optional accessory for use with Hypoguard blood glucose meters with data management capabilities. GlucoBalance transfers data from the meter's memory into a computer for enhanced data management. GlucoBalance is intended for use in home and clinical settings to assist people with diabetes and their health care professionals in review, analysis and evaluation of historical blood glucose test results to support diabetes management.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

prescription

(Division Sign-Off)

✓

---

over the counter

sion of Clinical Labo 510(k) Number

(Optional Format 3-10-98)