GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS

K964004 · Bayer Corp. · CFR · Feb 10, 1997 · Clinical Chemistry

Device Facts

• Record ID: K964004
• Device Name: GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
• Applicant: Bayer Corp.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

GLUCOMETER ENCORE Blood Glucose Test Strips are for the self-monitoring of blood glucose as an adjunct to the care of persons with diabetes*

Device Story

GLUCOMETER ENCORE Blood Glucose Test Strips; dry reagent hexokinase-based test; quantitative measurement of glucose in whole blood (10-600 mg/dL). Used with GLUCOMETER ENCORE meters; operated by patients or healthcare professionals in home/clinical settings. Input: whole blood sample; Output: quantitative glucose concentration. Results used for diabetes management/monitoring. Benefit: provides rapid, accurate blood glucose data for glycemic control.

Clinical Evidence

Bench and clinical performance evaluation conducted in U.S. medical center STAT laboratories. Compared GLUCOMETER ENCORE systems (using QA+ and QA meters) against Accu-Chek Advantage H and laboratory methods using fresh arterial whole blood specimens from catheters and deep sticks. Results showed good correlation with predicate and comparative methods.

Technological Characteristics

Dry reagent hexokinase method; quantitative measurement range 10-600 mg/dL (0.6-33.3 mmol/L); referenced to plasma/serum glucose values; compatible with GLUCOMETER ENCORE meters.

Indications for Use

Indicated for persons with diabetes and healthcare professionals in home and clinical settings for the self-monitoring of blood glucose.

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 ENCORE Blood Glucose Test Strips
• ACCU-CHEK® ADVANTAGE™, H Blood Glucose System (Boehringer Mannheim Corporation)

Submission Summary (Full Text)

{0}

K964004 FEB 10 1997
page 1 of 2

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared: October 4, 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 ENCORE® Blood Glucose Test Strips (Modified)
Common/Usual Name: Test for glucose in blood
Document Control Number: K96

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

Predicate Devices: GLUCOMETER ENCORE Blood Glucose Test Strips
ACCU-CHEK® ADVANTAGE™, H Blood Glucose System
(Boehringer Mannheim Corporation)

Device Description: GLUCOMETER ENCORE Blood Glucose Test Strips are over-the-counter home tests for glucose in blood. They are for use by persons with diabetes and by healthcare professionals in home settings and in healthcare facilities. GLUCOMETER ENCORE Blood Glucose Test Strips are for use with GLUCOMETER ENCORE® Blood Glucose Meters.

Intended Use: GLUCOMETER ENCORE Blood Glucose Test Strips are 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.

{1}

Bayer Corporation, Business Group Diagnostics
GLUCOMETER® ENCORE Blood Glucose Test Strips
S&E Summary page 2 of 2

## Technological Characteristics:

GLUCOMETER ENCORE Blood Glucose Test Strips are specific for glucose and have been referenced to give plasma/serum glucose values. The test provides a quantitative measurement of glucose in whole blood from 10 to 600 mg/dL (0.6 to 33.3 mmol/L). The GLUCOMETER ENCORE whole blood glucose test is based on the hexokinase method using dry reagent technology.

## Assessment of Performance:

GLUCOMETER ENCORE Blood Glucose Test Strips were used with the GLUCOMETER ENCORE® QA+ and GLUCOMETER ENCORE® QA Blood Glucose Meters to evaluate the performance of the systems with arterial whole blood specimens. The evaluation was carried out in the STAT Laboratories of a large U.S. medical center. Fresh arterial specimens collected from catheters and deep sticks were used. The performance of the two GLUCOMETER ENCORE Systems was compared to the Accu-Chek® Advantage™ H Blood Glucose Meter and to other laboratory methods for the determination of glucose. The GLUCOMETER ENCORE Systems gave glucose results which compared well with the performance of the predicate and other comparative methods.

## Conclusion:

The results of the clinical evaluation of GLUCOMETER ENCORE Blood Glucose Test Strips used with the GLUCOMETER ENCORE QA+ and GLUCOMETER ENCORE QA Blood Glucose Meters on arterial blood specimens demonstrated that the device is equivalent in performance to the predicate device and suitable for use with arterial blood specimens.