ASCENSIA BREEZE BLOOD GLUCOSE METER

K024062 · Bayer Corp. · CGA · Mar 3, 2003 · Clinical Chemistry

Device Facts

• Record ID: K024062
• Device Name: ASCENSIA BREEZE BLOOD GLUCOSE METER
• Applicant: Bayer Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The ASCENSIA™ BREEZE™ Blood glucose Meter is for the Self- Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.

Device Story

The Ascensia Breeze Blood Glucose Meter is an electrochemical, amperometric device for measuring glucose in whole blood. It utilizes dry reagent sensors (test strips) provided in cartridges of ten. The device is intended for use by persons with diabetes and healthcare professionals in home settings. The user applies a blood sample to the test strip; the meter performs an electrochemical measurement using glucose oxidase; the result is displayed as plasma-referenced glucose. The device provides frequent monitoring to assist in diabetes management.

Clinical Evidence

Clinical evaluation conducted at five sites comparing the Ascensia Breeze to the Ascensia DEX 2 predicate device. The study assessed performance in the hands of diabetic users. Results demonstrated the device is equivalent in performance to the predicate and suitable for its intended use.

Technological Characteristics

Amperometric glucose oxidase method; linear response range 10-600 mg/dL; results referenced to plasma glucose. Sensors are provided in cartridges of ten. Device is a handheld meter.

Indications for Use

Indicated for persons with diabetes and healthcare professionals in home settings for the measurement of glucose in venous and capillary whole blood samples drawn from the fingertip, palm, forearm, abdomen, and thigh.

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

• ASCENSIA™ DEX® 2

Submission Summary (Full Text)

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Bayer Corporation, Business Group Diagnostics Ascensia TM Breeze™ Blood Glucose Meter Page 1 of 2

## MAR 0 3 2003

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | December 2, 2002 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer Corporation, Business Group Diagnostics |
| Address: | 1884 Miles Avenue<br>P.O. Box 70<br>Elkhart, IN 46515<br>574.262.6928 |
| Contact: | George M. Tancos RAC<br>Manager, Regulatory Affairs |
| Device: | |
| | Trade/Proprietary Name: Ascensia ™ BREEZE™ Blood Glucose Meter |
| | Common/Usual Name: Test for glucose in whole blood -- Blood Glucose Meter |
| | Document Control Number: K024062 |
| Classification Name: | Division of Clinical laboratory Devices<br>Panel -- Clinical Chemistry and Toxicology<br>Classification Code -- 75 CGA (Glucose Oxidase, Glucose) |
| | In 21 CFR 862.1345, a glucose test system is classified as a Class II medical device. |
| Predicate Devices: | ASCENSIA™ DEX® 2<br>Manufactured by: Bayer Diagnostics, Mishawaka, IN |
| Device Description: | The ASCENSIA™ BREEZE™ consists of an electrochemical method- based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes. |
| Intended Use: | The ASCENSIA™ BREEZE™ Blood glucose Meter is for the Self- Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes. ¹ |

^{1 &}quot;Consensus Statement on Self-Monitoring of Blood glucose," Diabetes Care, vol. 10, No. 1, January-February 1987, pages 95-99.

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| Technological Characteristics: | The electronics of the ASCENSIA™ BREEZE™ Blood<br>Glucose Meter employs an amperometric glucose oxidase<br>method to measure glucose in blood. It is conceptually<br>similar as other blood glucose testing monitoring systems<br>available for blood glucose testing. The Reagent Test<br>Sensors are individually sealed in cartridges of ten<br>sensors. Blood glucose results are reference to plasma<br>glucose. The ASCENSIA™ BREEZE™ Blood Glucose<br>Meter has a linear response to glucose from 10-600<br>mg/dL. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Assessment of Performance: | An evaluation of the ASCENSIA™ BREEZE™ Blood<br>Glucose Meter was conducted at five clinical sites to<br>demonstrate the equivalence of the ASCENSIA™<br>BREEZE™ Blood glucose meter to the Ascensia DEX 2<br>Blood Glucose Meter, the predicate device, in the hands<br>of diabetics. |
| Conclusion: | The results of the evaluation of the ASCENSIA™<br>BREEZE™ Blood Glucose Meter demonstrate that the<br>meter is equivalent in performance to the predicate device<br>and suitable for its intended use. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three horizontal lines representing its wings and wavy lines representing its tail feathers.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 0 3 2003

Mr. George M. Tancos Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 1884 Miles Avenue P.O. Box 70 Elkhart, IN 46515-0070

Re: k024062

Trade/Device Name: ASCENSIA" BREEZE™ Blood Glucose Meter Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: CGA Dated: February 18, 2003 Received: February 24, 2003

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 ger.eral controls provisions of the Act include requirements for annual registration. Iisting 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). You may obtain other general information on your responsibilities under the Act 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 Butman

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): K024062

Device Name:

Indications for Use:

ASCENSIA™ BREEZE™ Blood Glucose Meter

The ASCENSIA BREEZE Blood Glucose Meter is used with the ASCENSIA™ AUTODISC™ Blood Glucose Test Strips and ASCENSIA™ AUTODISCTM CONTROLS for the measurement of glucose in whole blood. The ASCENSIA BREEZE Blood Glucose Meter is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings.

The ASCENSIA BREEZE Blood Glucose System is indicated for use with venous, and capillary whole blood samples drawn from the fingertip, palm, forearm, abdomen and thigh.

The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Sean Conroy

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number KE24062

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Per 21 CFR 801.109)

\$\varnothing R\$
and

**Over-The-Counter Use**

(Optional Format 1-2-96)