GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)

K020208 · Bayer Group Diagnostics · NBW · Apr 29, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020208
• Device Name: GLUCOMETER ELITE DIABETES CARE SYSTEM (MODIFIED)
• Applicant: Bayer Group Diagnostics
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The GLUCOMETER ELITE® and the GLUCOMETER ELITE® XL Blood Glucose Meters are used with GLUCOMETER ELITE® Test Strips to measure glucose levels in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The GLUCOMETER ELITE Diabetes Care System is an overthe-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Device Story

System consists of blood glucose meter and dry reagent test strips; utilizes electrochemical amperometric glucose oxidase method. Input: whole blood sample from finger or alternate puncture site. Meter transforms electrochemical signal into quantitative glucose concentration (range 20-600 mg/dL). Output: digital blood glucose reading displayed to user. Used by patients for home self-monitoring or by healthcare professionals in clinical settings. Results assist in diabetes management; provides adjunct data for clinical decision-making. Enables frequent monitoring to support glycemic control.

Clinical Evidence

Clinical study conducted with persons with diabetes. Evaluated performance of alternate puncture site testing compared to fingerstick testing. Results demonstrated that alternate site testing is equivalent to fingerstick testing within conditions specified in product labeling.

Technological Characteristics

Amperometric glucose oxidase method; dry reagent sensor (test strips). Linear response range: 20-600 mg/dL. Results referenced to plasma glucose. System is a handheld blood glucose meter.

Indications for Use

Indicated for persons with diabetes for self-monitoring of blood glucose in home settings or by healthcare professionals in clinical facilities. Used for measuring glucose levels in whole blood from finger or alternate puncture sites.

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

• GLUCOMETER ELITE® XL Blood Glucose Meter (K020208)
• GLUCOMETER ELITE® Test Strips (K020208)

Submission Summary (Full Text)

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APR 2 9 2002

Bayer Diagnostics GLUCOMETER ELITE® Diabetes Care System S&E Summary Page 1 of 2

## 510(k) SAFETY AND EFFECTIVENESS SUMMARY

January 18, 2002 Prepared: Bayer Diagnostics Submitter: 1884 Miles Avenue, P.O. Box 70 Address: Elkhart, IN 46515 [phone] George M. Tancos, RAC Contact: Manager, Regulatory Compliance Trade/Proprietary Name: GLUCOMETER ELITE® Diabetes Care Device: System Blood Glucose Meter Common/Usual Name: Blood Glucose Test Strips Document Control Number: K020208 Division of Clinical Laboratory Devices Classification: Panel - Clinical Chemistry and Toxicology Classification Code - 75CGA (Glucose Oxidase, Glucose) GLUCOMETER ELITE® Blood Glucose Meter Predicate Devices: GLUCOMETER ELITE® XL Blood Glucose Meter GLUCOMTER ELITE® Test Strips

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The GLUCOMETER ELITE® Diabetes Care System includes the Device Description: GLUCOMETER ELITE®, GLUCOMETER ELITE® XL Blood Glucose Meters and the GLUCOMETER ELITE® Test Strips. The system is an electrochemical method-based meter and dry reagent sensor (test strips) designed for testing blood glucose by persons with diabetes in the home or by healthcare professionals in healthcare facilities. The GLUCOMETER ELITE® Diabetes Care System is intended Intended Use: for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.4 Technological The GLUCOMETER ELITE® Diabetes Care System employs an Characteristics: amperometric glucose oxidase method to measure glucose in blood. It is conceptually the same as other blood glucose monitoring products available for blood glucose testing. Blood glucose results are referenced to plasma glucose. The System has a linear response to glucose from 20-600 mg/dL. Assessment of The GLUCOMETER ELITE® Diabetes Care System was studied Performance: in a clinical setting by persons with diabetes. The studies demonstrate that users can obtain blood glucose results from alternate puncture sites that are substantially equivalent to blood glucose results obtained from fingersticks within certain conditions explained in product labeling. The results of the clinical evaluation of the GLUCOMETER Conclusion: ELITE® Diabetes Care System demonstrate that the device can produce blood glucose results from alternate puncture sites that are equivalent to blood glucose results obtained from fingersticks within certain conditions explained in product labeling.

^{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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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 an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 2 9 2002

Mr. George M. Tancos Manager, Regulatory Compliance Bayer Corporation 1884 Miles Avenue P.O. Box 70 Elkhart, IN 46515-0070

Re: k020208

Trade/Device Name: GLUCOMETER ELITE® Diabetes Care System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 28, 2002 Received: March 29, 2002

Dear Mr. Tancos:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use suated in the encreative) it its 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 I ou may , aron's 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 11 your device 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 or uny 1 vith 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.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 510(k) premarket This letter will and it your ding of substantial equivalence of your device to a legally marketed noutication. THE I DIT 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, [phone]. In and 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 Information on 7001 165port 105port Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.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

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510(k) Number (if known): K020208

Device Name:

GLUCOMETER ELITE ® Diabetes Care System

Indications for Use:

The GLUCOMETER ELITE® and the GLUCOMETER ELITE® XL Blood Glucose Meters are used with GLUCOMETER ELITE® Test Strips to measure glucose levels in whole blood from specimens taken from the fingers or an alternate puncture site within certain conditions. The GLUCOMETER ELITE Diabetes Care System is an overthe-counter (OTC) device used by persons with diabetes in a home setting and by healthcare professionals in healthcare facilities. The frequent monitoring of blood glucose is an adjunct to the care of persons with diabetes.

Jean Cooge

sion Sign-Off)
ion of Clinical Laboratory Devices
5.0(k) Number K020208

(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) OR

Over-The-Counter Use