ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM

K944459 · Boehringer Mannheim Corp. · CGA · Apr 17, 1996 · Clinical Chemistry

Device Facts

• Record ID: K944459
• Device Name: ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Boehringer Mannheim Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Apr 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

For use by professionals and people with diabetes for the quantitative determination of glucose in whole blood.

Device Story

System consists of Instant Test Strip and Accu-Chek InstantPlus or Instant DM Monitor; measures blood glucose via colorimetric change on test strip; utilizes glucose oxidase reaction; non-wipe technology; requires lot-specific coding; used by professionals and patients with diabetes in clinical or home settings; monitor detects color change and displays quantitative glucose result; assists in diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and performance comparison to predicate.

Technological Characteristics

Glucose oxidase dry chemistry test strip; colorimetric sensing; lot-specific coding; non-wipe technology; blood glucose monitoring system.

Indications for Use

Indicated for professional and home use by individuals with diabetes for quantitative measurement of glucose in whole blood samples.

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

• Accu-Chek® Easy™ System

Submission Summary (Full Text)

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K944459
APR 17 1996

# Attachment #5

## Summary of Safety and Effectiveness

123

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124
# Summary of Safety and Effectiveness

| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
| --- | --- |
| 1. | Boehringer Mannheim Corporation
9115 Hague Road
Indianapolis, Indiana 46250
Contact Person: Michael Flis
October 23, 1995 |
| 2. | Panel = Clinical Chemistry (75)
Classification No = CGA
Classification Name = Glucose Oxidase, Glucose
Regulation No = 21 CFR 862.1345
Classification = II |
| 3. | We claim equivalence to Boehringer Mannheim Corporation’s Accu-Chek® Easy™ System. |
| 4. | The Instant™ Test Strip, when used as directed with either the Accu-Chek® InstantPlus or Instant DM Monitor, will accurately measure the blood glucose value. The strip changes color as it reacts to glucose in a drop of blood, and the monitor measures this color change. The monitor displays the blood glucose result. |
| 5. | Intended Use: For use by professionals and people with diabetes for the quantitative determination of glucose in whole blood. |
| 6. | As noted above in section 3, we claim equivalence to Boehringer Mannheim Corporation’s Accu-Chek® Easy™ System. |

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# SUMMARY OF SAFETY AND EFFECTIVENESS

## ACCUTREND® GLUCOSE TEST

The Accutrend® Glucose Test is substantially equivalent to our Accu-Chek Easy Self Blood Glucose Monitoring System. Both systems are used to measure glucose in whole blood. The procedure for both tests entails applying a capillary blood sample to a dry chemistry test strip. Both test system utilize non-wipe technologies. The glucose oxidase reaction is measured in both tests. Both test systems have lot-specific coding for each lot of test strips. Finally, both the Accutrend GC and Accu-Chek Easy systems are blood glucose monitoring devices which have been cleared specially for home use.

Boehringer Mannheim Corporation
9115 Hague Road
Indianapolis, Indiana 46256