ELECT BLOOD GLUCOSE MONITORIG SYSTEM

K961985 · Selfcare, Inc. · CGA · Sep 5, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961985
• Device Name: ELECT BLOOD GLUCOSE MONITORIG SYSTEM
• Applicant: Selfcare, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Elect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor effectiveness of diabetes control.

Device Story

System includes glucose reagent test strips, amperometric meter, and quality control solution. User inserts strip into meter; applies fingerstick capillary blood sample. Meter measures electrical current generated by glucose oxidase reaction; current proportional to glucose concentration. Result displayed in 20 seconds. System calibrated to plasma-equivalent values. Used by patients at home for self-monitoring of blood glucose levels to aid diabetes management.

Technological Characteristics

Amperometric meter; glucose reagent test strips; glucose oxidase enzymatic biosensor; electrochemical detection; plasma-equivalent calibration.

Indications for Use

Indicated for diabetics at home for quantitative measurement of glucose in fresh capillary whole blood to monitor diabetes control.

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

• Precision QID Blood Glucose Monitoring System
• Glucometer Elite Diabetes Care System

Submission Summary (Full Text)

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Selfcare, Inc.
200 Prospect Street
Waltham, Massachusetts 02154
Telephone [phone]
Facsimile 617 647 3939
K961985
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# selfcare
## SEP 5 1996

### 510(k) Summary

**Manufacturer:** Selfcare, Inc.
200 Prospect Street
Waltham, MA 02154
Telephone: [phone]
Fax: [phone]

**Contact Person:** Carol Adiletto

**Date:** 20th May 1996

**Device Name:** Elect Blood Glucose Monitoring System

**Common Name:** Blood glucose meter and reagent test strips for blood glucose

**Classification:** Class II as per 21 CFR 862.1345. Glucose test system; Code 75 CGA (Glucose oxidase, glucose) Classification panel - clinical chemistry

**Equivalent Devices:** Precision QID Blood Glucose Monitoring System Glucometer Elite Diabetes Care System

## Product Description

The Elect Blood Glucose Monitoring System comprises a glucose reagent test strip, a amperometric meter and a quality control solution. The user inserts a test strip in the Elect Meter and applies a small drop of blood from a fingerstick to the sample point on the strip. The meter measures the electrical current that is generated which is proportional to the concentration of glucose present in the blood sample. The blood glucose result is displayed in 20 seconds. The system is calibrated to give a result equivalent to a plasma value, the measurement used by most clinical laboratories.

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Page 67

## Intended Use:

The Elect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The Elect System is intended for use outside the body (in vitro diagnostic use) by diabetics at home as an aid to monitor effectiveness of diabetes control.

## Substantial Equivalence:

The Elect Blood Glucose Monitoring System is similar in technological characteristics, methodology and intended use to the predicate devices listed above. The Elect System utilizes similar biosensor methodology based on a standard enzymatic methodology employing the enzyme glucose oxidase coupled to an electrochemical detection system to measure glucose levels in whole blood.