GLUCOMETER DEX DIABETES CARE SYSTEM

K963500 · Bayer Corp. · CGA · Jan 21, 1997 · Clinical Chemistry

Device Facts

• Record ID: K963500
• Device Name: GLUCOMETER DEX DIABETES CARE SYSTEM
• Applicant: Bayer Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The GLUCOMETER DEX Diabetes Care System is for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.

Device Story

System comprises blood glucose meter, test sensor discs, and control solutions; measures blood glucose via amperometric glucose oxidase method; intended for OTC home use by diabetics and professional use in clinical settings; provides quantitative blood glucose results; aids in diabetes management; results referenced to plasma glucose; linear range 10-600 mg/dL.

Clinical Evidence

In-house and clinical studies conducted by healthcare professionals and persons with diabetes; demonstrated results substantially equivalent to current blood glucose monitoring methods.

Technological Characteristics

Amperometric glucose oxidase biosensor; linear range 10-600 mg/dL; results referenced to plasma glucose; test sensor discs packaged in sets of ten.

Indications for Use

Indicated for self-monitoring of blood glucose in persons with diabetes; for use by patients in home settings and by healthcare professionals in home and clinical 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 Monitoring System
• YSI Model 2300 STAT Plus Analyzer
• ACA® Discrete Clinical Analyzer
• Hitachi 704 chemistry analyzer
• Hitachi 747 chemistry analyzer

Submission Summary (Full Text)

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JAN 21 1997
K963500
page 1 of 2

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared: August 30, 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® DEX™ Diabetes
Care System
Common/Usual Name: Test for glucose in blood
Blood glucose meter
Control material
Document Control Number: K96

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

Predicate Devices: GLUCOMETER ELITE® Blood Glucose Monitoring System;
YSI Model 2300 STAT Plus Analyzer; ACA® Discrete Clinical
Analyzer; Hitachi 704 chemistry analyzer; Hitachi 747 chemistry
analyzer.

Device Description: The GLUCOMETER DEX Diabetes Care System consists of the
GLUCOMETER® DEX™ Blood Glucose Meter;
GLUCOMETER® DEX™ Blood Glucose Test Sensor Disc; and
the GLUCOMETER® DEX™ Controls (Normal, Low and High).
The GLUCOMETER DEX Diabetes Care System is an over-the-
counter (OTC) home test for glucose in blood. It is for use by
persons with diabetes and by healthcare professionals in home
settings and in healthcare facilities.

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Bayer Corporation, Business Group Diagnostics
GLUCOMETER® DEX™ Diabetes Care System
S&E Summary page 2 of 2

Intended Use:
The GLUCOMETER DEX Diabetes Care System is for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes.*

Technological Characteristics:
The GLUCOMETER DEX Diabetes Care System employs an 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. The test sensor discs are individually sealed in a package of ten. Blood glucose results are referenced to plasma glucose. The System has a linear response to glucose from 10 - 600 mg/dL.

Assessment of Performance:
The performance of the GLUCOMETER DEX Diabetes Care System was studied in-house and in clinical settings by healthcare professionals and 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 in-house and clinical evaluations of the GLUCOMETER DEX Diabetes Care System demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use.

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