ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM

K062347 · Bayer Healthcare, LLC · NBW · Nov 22, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062347
• Device Name: ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bayer Healthcare, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Ascensia® BREEZE®2 Blood Glucose Monitoring System consisting of the Ascensia® BREEZE®2 Blood Glucose Meter, Ascensia® BREEZE®2 Reagent Strips and Ascensia® BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia® BREEZE®2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia® BREEZE®2 Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes. Ascensia® Breeze®2 Blood Glucose Monitoring System is not for use with neonatal blood specimens. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Device Story

System measures glucose in whole blood using capillary samples from fingertip, palm, or forearm. Device comprises meter, reagent strips, and control solution. Operates via amperometric glucose oxidase method; provides plasma-referenced glucose results. Used by patients with diabetes in home or clinical settings for self-monitoring. Results assist patients and healthcare providers in diabetes management. System is an OTC device; not for neonatal use.

Clinical Evidence

Clinical validation performed with persons with diabetes. Subject meter results from capillary blood samples compared against healthcare professional-obtained BREEZE®2 results and laboratory glucose analyzer results. Studies demonstrated improved performance compared to the original Ascensia® BREEZE® system.

Technological Characteristics

Amperometric glucose oxidase method; plasma-referenced results; linearity range 20-600 mg/dL. System includes meter, reagent strips, and control solution.

Indications for Use

Indicated for persons with diabetes for self-monitoring of blood glucose via capillary blood from fingertip, palm, or forearm. Not for use with neonatal blood specimens.

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 BREEZE® Diabetes Care System (K024062)

Submission Summary (Full Text)

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

Bayer HealthCare Diabetes Care

Image /page/0/Picture/1 description: The image shows the Bayer company logo. The logo is a circle with the word "BAYER" written vertically in the center. The letters are arranged in a cross shape, with the "Y" in the middle. The logo is simple and recognizable, and it is often used on Bayer products and advertising materials.

NOV 2 1 2006

## 510(k) SUMMARY

## Ascensia® BREEZE®2 Blood Glucose Monitoring System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is k062347

| Prepared: | August 9, 2006 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer HealthCare, Diabetes Care |
| Address: | Bayer HealthCare, Diabetes Care<br>430 South Beiger Street<br>Mishawaka, IN 46544<br>Phone [phone]; FAX [phone] |
| Contact: | Marc A. Henn, Regulatory Affairs Specialist |
| Device: | Trade/Proprietary Name: Ascensia® BREEZE®2 Blood<br>Glucose Monitoring System |
| Common/Usual Name: | Blood Glucose Meter |
| Classification: | Division of Clinical Laboratory Devices<br>Panel - Clinical Chemistry and Toxicology<br>Classification Code - 75 CGA, (Glucose Oxidase, Glucose) |
| Predicate Device: | Ascensia BREEZE® Diabetes Care System, K024062 |
| Device Description: | The Ascensia® BREEZE®2 Blood Glucose Monitoring System<br>consists of:<br>1. Ascensia® BREEZE®2 Blood Glucose Monitor<br>2. Ascensia BREEZE®2 Blood Glucose Test Strips<br>3. Ascensia BREEZE®2 Control Solution |

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

## Page 2 of 2

| Intended Use: | The Ascensia® BREEZE®2 Blood Glucose Monitoring<br>System consisting of the Ascensia® BREEZE®2 Blood<br>Glucose Meter, Ascensia® BREEZE®2 Reagent Strips and<br>Ascensia® BREEZE®2 Control Solution is for the<br>measurement of glucose in whole blood. The Ascensia®<br>BREEZE®2 Blood Glucose Monitoring System allows the<br>user an option to use the palm and forearm in addition to the<br>fingertip (testing) to collect capillary blood for self-monitoring<br>of blood glucose within certain conditions as explained in the<br>labeling. Ascensia® BREEZE®2 Blood Glucose Monitoring<br>System is an over-the-counter (OTC) device used by<br>persons with diabetes. Ascensia® Breeze®2 Blood Glucose<br>Monitoring System is not for use with neonatal blood<br>specimens. The frequent monitoring of blood glucose is an<br>adjunct to the care of persons with diabetes. |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The Ascensia® BREEZE®2 Blood Glucose Monitoring<br>System employs an amperometric glucose oxidase method<br>to measure glucose in blood. It is conceptually the same as<br>other blood glucose monitoring products available for blood<br>glucose testing. Blood glucose results are referenced to<br>plasma glucose. The system has a linearity response to<br>glucose from 20-600 mg/dL. |
| Assessment of<br>Performance: | A validation of the Ascensia® BREEZE®2 Blood Glucose<br>Monitoring System was performed in a clinical setting by<br>persons with diabetes. The subject meter results for<br>capillary blood samples were compared with BREEZE®2<br>results obtained by a healthcare professional and results of<br>a laboratory glucose analyzer. The studies showed<br>improved performance compared with past clinical studies of<br>the original Ascensia® BREEZE® Blood Glucose Monitoring<br>System. |
| Conclusion: | The results of the clinical evaluations of The Ascensia®<br>BREEZE®2 Blood Glucose Monitoring System demonstrated<br>that the device can produce blood glucose results that are<br>substantially equivalent to results obtained on the predicate<br>device. |

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the eagle in a circular fashion. The logo is rendered in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Roger Sonnenburg Manager, Regulatory Affairs Bayer HealthCare, LLC 430 South Beiger St. Mishawaka, IN 46544

NOV 2 1 2006

Re: k062347

Trade/Device Name: Ascensia® BREEZE®2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX Dated: November 15, 2006 Received: November 16, 2006

Dear Mr. Sonnenburg:

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).

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

Page 2 -

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/industry/support/index.html.

Sincerely vours.

Alberto Gutierrez
Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known): k062347

Device Name: Ascensia® BREEZE®2 Blood Glucose Monitoring System

Indications For Use: The Ascensia BREEZE®2 Blood Glucose Monitoring System consisting of the Ascensia "BREEZE"2 Blood Glucose Meter, Ascensia" BREEZE® Reagent Strips and Ascensia BREEZE®2 Control Solution is for the measurement of glucose in whole blood. The Ascensia BREEZE® 2 Gonton Solution in of the measurement of
glucose in whole blood. The Ascensia® BREEZE® 2 Blood Glucose Monitoring System allows the user an option to use the palm and forearm in addition to the fingertip (testing) to collect capillary blood for self-monitoring of blood glucose within certain conditions as explained in the labeling. Ascensia BREEZE®2 Blood Glucose Monitoring System is an over-the-counter (OTC) device used by persons with diabetes. Ascensia BREEZE 2 Blood Glucose Monitoring System is not for use with neonatal blood specimens. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of

L062347