ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL

K024234 · Bayer Corp. · NBW · Jan 23, 2003 · Clinical Chemistry

Device Facts

• Record ID: K024234
• Device Name: ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
• Applicant: Bayer Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Ascensia WinGlucofacts and the Ascensia WinGlucofacts Professional software provides data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of data by individuals or health care professionals.

Device Story

Device consists of software (CD) and connecting cable; used with compatible blood glucose meter and PC. Captures blood glucose results from meter; performs data management using standard statistical and graphical tools. Used in home and healthcare facilities by patients or healthcare professionals. Output displayed on PC screen to facilitate data review; assists in clinical decision-making by providing organized glucose trends and statistics. Benefits patient by enabling structured monitoring and review of glycemic control.

Clinical Evidence

Bench testing only. Internal and external performance/validation studies were conducted to demonstrate satisfactory performance of the software in the hands of end users.

Technological Characteristics

Software-based data management system; includes connecting cable for data transfer from blood glucose meter to PC. Utilizes standard statistical and graphical tools for data visualization. Operates on PC platform.

Indications for Use

Indicated for use by persons with diabetes and healthcare professionals as an accessory to Ascensia Blood Glucose monitoring systems for data transfer and management in home and clinical settings.

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

• Glucofacts® Data Management System (K861844)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

JAN 2 3 2003

# Submitter Information

| Contact person: | George M. Tancos |
|-----------------|----------------------------------------|
| Address: | 1884 Miles Avenue<br>Elkhart, IN 46515 |
| Phone: | 574.262.6928 |
| FAX: | 574.262.4945 |
| E-mail: | [e-mail] |
| Date Prepared: | December 19, 2002 |

## Device Information

| Proprietary Name: | The Ascensia™ WinGlucofacts® |
|-------------------|--------------------------------------------------------------|
| | Ascensia™ WinGlucofacts® Professional |
| Common Name: | Software and connecting Cable |
| Classification: | Division of Clinical Laboratory Devices |
| | Panel - Clinical Chemistry and Toxicology |
| | Classification Code 21 CFR 862.2100 |
| | (75 JQP Calculator/Data Processing Module, for Clinical Use) |

## Predicate Device Information

| Name: | Glucofacts® Data Management System |
|----------------|------------------------------------|
| Manufacturer: | Bayer Diagnostics |
| | 430 S. Bieger Street |
| | Mishawaka, In 46544 |
| 510(k) Number: | K861844 |

## Device Description

The Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software consist of a CD, and a connecting cable. It is to be used with a compatible blood glucose meter and a Personal Computer (PC). The software provides data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of the data by individuals or health care professionals.

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### Statement of Intended Use:

The Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software provides data management of patient blood glucose results and uses standard statistical and graphical tools/techniques to facilitate the review of data by individuals or health care professionals.

## Summary of Technological Characteristics:

The Ascensia ***Glucofacts and the Ascensia ***Glucofacts Professional software is used to capture blood glucose meter results and graphically display the information. It uses standard statistical and graphical tools/techniques to facilitate the review of the data by individuals or health care professionals.

### Performance Data:

Internal and external Performance/Validation studies were conducted. The studies demonstrate satisfactory performance of the Ascensia ""Glucofacts and the Ascensia Win Glucofacts Professional software in the hands of end users.

#### Conclusion:

The results of in-house and external evaluations of the Ascensia ""Glucofacts and the Ascensia ""Glucofacts Professional software demonstrate that these devices are equivalent in performance to the predicate devices and suitable of its intended use.

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Re:

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 3 2003

Mr. George M. Tancos R.A. C. Manager, Regulatory Affairs Bayer Corporation 1884 Miles Avenue, P.O. Box 70 Elkhart, IN 46514-0070

> k024234 Trade/Device Name: Ascensia™ WINGlucofacts® Ascensia™M WNGlucofacts® Professional Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: December 19, 2002 Received: December 23, 2002

Dear Mr. Tancos:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K

Device Name:

Ascensia™ WinGlucofacts® Ascensia™ WinGlucofacts® Professional

The Ascensia WirGlucofacts and the Ascensia Indications for Use: WinGlucofacts Professional software are accessories to the AscensiaTM Blood Glucose monitoring systems. The Ascensia ""Glucofacts and the Ascensia """Glucofacts Professional software are Over-The Counter (OTC) devices used by persons with diabetes and by healthcare professionals for data transfer in the home and in healthcare facilities.

Ham Coogen
(Division Sign-Off)
Division Clinical Laboratory Devices
510(k Mumber. K024234

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Use (Per 21 CFR 801.109) OR

**Over-The-Counter**