ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM

K043158 · Bayer Healthcare, LLC · NBW · Dec 22, 2004 · Clinical Chemistry

Device Facts

• Record ID: K043158
• Device Name: ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Bayer Healthcare, LLC
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Ascensia BRIO™ Blood Glucose Monitoring System is for the Self-Monitoring of Blood Glucose as an adjunct to the care of person with diabetes.

Device Story

The Ascensia BRIO™ Blood Glucose Monitoring System is an electrochemical meter used with reagent test strips to measure glucose levels in fingertip capillary whole blood. The device is intended for use by persons with diabetes or healthcare professionals in home or clinical settings. The system measures the electrical current generated by the reaction of glucose with glucose oxidase on the test strip electrode. Results are displayed to the user to assist in the management of diabetes. The system provides a linear response to glucose concentrations ranging from 30-550 mg/dL.

Clinical Evidence

Clinical evaluations were conducted internally and externally by persons with diabetes. Results demonstrated that users obtain blood glucose measurements substantially equivalent to current methods. No specific sensitivity, specificity, or p-values were provided in the summary.

Technological Characteristics

Electrochemical sensing using glucose oxidase reagent on test strip electrodes. Linear measurement range: 30-550 mg/dL. System is specific for glucose and referenced to plasma glucose values. Form factor includes a meter and 50-count plastic bottles of test strips.

Indications for Use

Indicated for use with fingertip capillary whole blood specimens for the quantitative measurement of glucose in persons with diabetes. Used as an adjunct to the care of persons with diabetes.

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 Elite Diabetes Care System (k020208, k990649, k991242)

Submission Summary (Full Text)

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DEC 2 2 2004

Bayer HealthCare LLC ASCENSIA BRIO™ Blood Glucose Monitoring System S&E Summary Page 1 of 2

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

| Prepared: | November 8, 2004 |
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| Submitter: | Bayer HealthCare LLC |
| Address: | 1884 Miles Avenue, P.O. Box 70<br>Elkhart, IN 46515<br>574.262.6928 |
| Contact: | George M. Tancos<br>Manager, Regulatory Affairs |
| Device: | Trade/Proprietary Name: Ascensia BRIO™ Blood Glucose<br>Monitoring System |
| | Common/Usual Name: Blood Glucose Meter |
| | Document Control Number: K04 3/58 |
| Classification: | Division of Clinical Laboratory Devices<br>Panel - Clinical Chemistry and Toxicology<br>Classification Code – 75 CGA (Glucose Oxidase, Glucose) |
| Predicate Devices: | ASCENSIA ELITE™ Diabetes Care System |
| Device Description: | The Ascensia BRIO™ Blood Glucose Monitoring System consists<br>of an electrochemical method-based meter and reagent sensor (test<br>strips) designed for testing glucose by persons with diabetes or by<br>healthcare professionals in the home or in healthcare facilities. |
| Intended Use: | The Ascensia BRIO™ Blood Glucose Monitoring System is for the<br>Self-Monitoring of Blood Glucose as an adjunct to the care of<br>person with diabetes. ¹ |

^{1 &}quot;Consensus Statement on Self-Monitoring of Blood Glucose, " Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95.99

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| Technological<br>Characteristics: | The Ascensia BRIOTM Blood Glucose Monitoring System test is based on the measurement of electrical current caused by the reaction of glucose with the reagents (glucose oxidase) on the electrode of the test strip. It is conceptually the same as other blood glucose monitoring products available for blood glucose testing. There are 50 test strips in a plastic bottle. The system is specific for glucose and has been referenced to plasma glucose values from fingerstick capillary samples. The System has a linear response to glucose from 30-550 mg/dL. |
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| Assessment of<br>Performance: | An evaluation of the Ascensia BRIOTM Blood Glucose Monitoring System was studied both internally and externally in a clinical setting by persons with diabetes. The studies demonstrated that users can obtain blood glucose results that are substantially equivalent to current methods for blood glucose. |
| Conclusion: | The results of clinical evaluations of the Ascensia BRIOTM Blood Glucose Monitoring System demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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" around the perimeter. Inside the circle is a stylized image of a human figure with three horizontal lines above it, resembling an abstract representation of a person and their spirit or well-being.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 2 2 2004

Mr. George M. Tancos Manager, Regulatory Affairs Bayer HealthCare LLC. 1884 Miles Avenue, P.O. Box 70 Elkhart, IN 46514-0070

Re: k043158

> Trade/Device Name: Ascensia BRIOTM Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: November 12, 2004 Received: November 15, 2004

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). 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,

Sincerely yours,

Cornelia B. Lorkis

Cornelia B. Rooks, MA Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

(If known). (86-2151)

Device Name: Ascensia BRIO™ Blood Glucose Monitoring System

Indications For Use:

The Ascensia BRIO™ Blood Glucose Meter is used with Ascensia® EASYFILL™ Blood Glucose Test Strips and ASCENSIA® EASYFILL™ CONTROL SOLUTIONS (Low, Normal, and High) for the measurement of glucose in whole blood. The Ascensia BRIO™ Blood Glucose Monitoring System is an Over-the-Counter (OTC) device used by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities.

The Ascensia® Brio™ Blood Glucose Monitoring System is indicated for use with fingertip capillary whole 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 -XX-(21 CFR 807 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)

| Carol C. Benson |
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Division Sign-Off

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