GLUCOMETER ELITE BLOOD GLUCOSE METER

K964630 · Bayer Corp. · CGA · Feb 10, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964630
• Device Name: GLUCOMETER ELITE BLOOD GLUCOSE METER
• Applicant: Bayer Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The GLUCOMETER ELITE Blood Glucose Meter is for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.

Device Story

Electrochemical blood glucose meter; uses dry reagent sensors (test strips) to measure glucose levels. Operated by patients or healthcare professionals in home/clinical settings. Modified electronics reduce result time (60s to 30s); expanded operating range (20-600 mg/dL); increased memory (20 results); improved calibration/temperature correction. Provides quantitative glucose concentration output to assist diabetes management.

Clinical Evidence

Clinical evaluation conducted at three sites comparing modified meter to predicate device. Participants included diabetics and healthcare professionals. Results demonstrated equivalent performance.

Technological Characteristics

Electrochemical sensing principle; dry reagent test strips. Modified electronics; ROM capacity increased to 20 results; operating range 20-600 mg/dL. Features improved calibration and temperature correction algorithms. Form factor modified with top-loading test slot.

Indications for Use

Indicated for persons with diabetes or healthcare professionals for self-monitoring of blood glucose in home or healthcare facility 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

• GLUCOMETER ELITE® Blood Glucose Meter (manufactured by Kyoto Daiichi Kagaku Co., Ltd.)

Submission Summary (Full Text)

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K964630

Bayer Corporation, Business Group Diagnostics

GLUCOMETER ELITE® Blood Glucose Meter

510(k) Safety and Effectiveness Summary

Page 1 of 2

FEB 10 1997

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared: November 18, 1996

Submitter: Bayer Corporation, Business Group Diagnostics

Address: 1884 Miles Avenue, P. O. Box 70
Elkhart, IN 46515
[phone]

Contact: Rosanne M. Savol, R.A.C.
Manager, Regulatory Affairs

Device: Trade/Proprietary Name: GLUCOMETER ELITE® Blood Glucose Meter
Common/Usual Name: Blood Glucose Meter
Document Control Number: K96

Classification: Division of Clinical Laboratory Devices
Panel - Clinical Chemistry and Toxicology
Classification Code - 75 CGA (Glucose Oxidase, Glucose)

Predicate Device: GLUCOMETER ELITE® Blood Glucose Meter
Manufactured by Kyoto Daiichi Kagaku Co., Ltd. of Kyoto, Japan

Device Description: The GLUCOMETER ELITE System consists of an electrochemical method-based meter and dry reagent sensors (test strips) designed for testing glucose by persons with diabetes or by healthcare professionals in the home or in healthcare facilities.

Intended Use: The GLUCOMETER ELITE Blood Glucose Meter is for the Self-Monitoring of Blood Glucose as an adjunct to the care of persons with diabetes.*

* "Consensus Statement on Self-Monitoring of Blood Glucose," Diabetes Care, Vol. 10, No. 1, January-February 1987, pp. 95-99.

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Bayer Corporation, Business Group Diagnostics
GLUCOMETER ELITE® Blood Glucose Meter
510(k) Safety and Effectiveness Summary
Page 2 of 2

## Technological Characteristics:

The electronics of the GLUCOMETER ELITE Blood Glucose Meter have been modified to reduce the time for obtaining a result from 60 to 30 seconds. The operating range has been expanded from 40 - 500 mg/dL to 20 - 600 mg/dL. The capacity of the read only memory (ROM) has been increased from retaining 10 results to 20 and improvements in calibration and temperature correction have been implemented. In addition, cosmetic changes to the case give the meter a new appearance and the test slot has been moved from the left side to the top of the meter.

## Assessment of Performance:

An evaluation of the modified GLUCOMETER ELITE Blood Glucose Meter was conducted at three clinical sites to demonstrate the equivalence of the modified meter to the currently used GLUCOMETER ELITE Blood Glucose Meter, the predicate device, in the hands of diabetics and healthcare professionals.

## Conclusion:

The results of the evaluation of the GLUCOMETER ELITE Blood Glucose Meter demonstrate that the modified meter is equivalent in performance to the predicate device and suitable for its intended use.