EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM

K961337 · Medisense, Inc. · CGA · Jun 21, 1996 · Clinical Chemistry

Device Facts

• Record ID: K961337
• Device Name: EXACTECH RSG BLOOD GLUCOSE TESTING SYSTEM
• Applicant: Medisense, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jun 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ExacTech RSG Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The product is designed for home or professional use.

Device Story

ExacTech RSG Blood Glucose Testing System uses amperometric biosensor technology to measure glucose in fresh capillary whole blood. User inserts test strip, applies blood sample, and presses sensor button. Glucose oxidase catalyzes oxidation of glucose to gluconic acid; electrochemical mediator transfers electrons to electrode surface, generating current proportional to glucose concentration. Device provides reading after 30-second countdown. Used in home or professional settings (clinics, physician offices) by patients or healthcare providers. Revised hardware improves strip insertion, initiation, and display readability. Software includes pre-programmed universal calibration, eliminating manual user calibration. Output allows healthcare providers to assess glycemic status and manage patient diabetes.

Clinical Evidence

Clinical study at three sites (clinic, physician office, research center) with 178 subjects (ages 9-88). Accuracy evaluated against YSI Analyzer; ExacTech RSG showed correlation coefficient (r) of 0.979 (n=288). Precision evaluated via 20-replicate venous blood testing; CV% ranged from 2.9% to 5.1% across tested glucose levels. Results indicate performance comparable to predicate ExacTech system.

Technological Characteristics

Amperometric biosensor; glucose oxidase enzyme; electrochemical mediator. Hardware revised for improved strip insertion and display. Software includes pre-programmed universal calibration. Standalone handheld device.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood for patients requiring blood glucose monitoring, including those with NIDDM and IDDM, aged 9 to 88 years.

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

• ExacTech Blood Glucose Testing System (K863468)

Reference Devices

• YSI Analyzer

Submission Summary (Full Text)

{0}

MEDISENSE®
JUN 21 1996
K961337

MediSense, Inc.
266 Second Avenue
Waltham, MA 02154
Telephone: [phone]
Fax: [phone]

# 510(k) Summary

Submitter/
Contact Person: Michael Halpin, Manager Regulatory and Clinical Affairs
MediSense, Inc.
266 Second Avenue
Waltham, MA 02154
Telephone: #[phone]
Fax: #[phone]

Date Prepared: April 18, 1996

Device Name: ExacTech RSG Blood Glucose Testing System

Common Name: Blood Glucose Test System

Classification: “Glucose Test System” - Class II per CFR 862.1345

Predicate Devices: ExacTech Blood Glucose Testing System - K863468

Description: The ExacTech RSG Blood Glucose Testing System utilizes amperometric biosensor technology to quantitatively measure glucose in whole blood and control solutions. After inserting a test strip into the sensor, a drop of whole blood or control solution is applied to the target area of the test strip and the sensor button is pressed. A countdown begins and glucose oxidase catalyzes the oxidation of glucose to produce gluconic acid. During the reaction, electrons are transferred by an electrochemical mediator to the electrode surface, generating a current that is measured by the ExacTech RSG Sensor. The size of the current is proportional to the amount of glucose present in the sample, thus giving an accurate reading of glucose concentration after 30 seconds.

Intended Use: The ExacTech RSG Blood Glucose Testing System is intended for in vitro diagnostic use (i.e., for external use only) for the quantitative measurement of glucose in fresh capillary whole blood. The product is designed for home or professional use.

Comparison to Predicate Device: The ExacTech RSG Blood Glucose Testing System has technological characteristics equivalent to those of the predicate ExacTech Blood Glucose Testing System.

The hardware for the ExacTech RSG Sensor has been revised compared to the predicate ExacTech Sensor to improve user features such as ease of test strip insertion, ease of test initiation and display readability. The software for the ExacTech RSG Sensor has been revised compared to the predicate ExacTech software to include pre-programmed universal calibration information eliminating the need for a calibration procedure.

Dedicated to Personal Health Management

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The only design difference between the new ExacTech RSG test strips and the predicate ExacTech test strips is the method of calibration. ExacTech RSG test strips do not require a user calibration procedure because the sensor is pre-programmed with universal calibration information specific to ExacTech RSG test strips.

## Performance Studies:

Comparative nonclinical testing of the ExacTech RSG Blood Glucose Testing System and the standard ExacTech Blood Glucose Testing System included linearity and dynamic range testing. The performance of the ExacTech RSG System was determined to be comparable to the performance of the standard ExacTech System.

Comparative clinical testing of the ExacTech RSG Blood Glucose Testing System and the standard ExacTech Blood Glucose Testing System was performed at three sites and included a clinic, physician’s office, and clinical research center. A total of 178 subjects (34% male, 66% female) ranging in age from 9 to 88 years participated in the study. The majority of participants were either White or Hispanic. A diversity of both education and occupation was observed at all sites. Two of the sites had a higher percentage of subjects with NIDDM and one site had a higher percentage of subjects with IDDM.

To evaluate accuracy, capillary whole blood was collected from each subject and tested by a trained operator on both the new ExacTech RSG and standard ExacTech Systems, as well as a YSI Analyzer. Results for the three sites are summarized below and indicate that the accuracy of the ExacTech RSG System is comparable to the accuracy of the standard ExacTech System.

| | ExacTech RSG System | Standard ExacTech System |
| --- | --- | --- |
| Correlation Coefficient (r) | 0.979 | 0.983 |
| Slope (m), mg/dL | 0.971 | 0.925 |
| Y-intercept, mg/dL | 2.2 | 4.7 |
| N | 288 | 170 |

To evaluate precision, venous whole blood was tested twenty times on both the new ExacTech RSG and standard ExacTech Systems. Results obtained at one of the sites are summarized below and indicate that the precision of the ExacTech RSG System is comparable to the precision of the standard ExacTech System.

| ExacTech RSG System | | | Standard ExacTech System | | |
| --- | --- | --- | --- | --- | --- |
| Mean,
mg/dL | SD,
mg/dL | CV,
% | Mean,
mg/dL | SD,
mg/dL | CV,
% |
| 59.1 | 3.03 | 5.1 | 53.1 | 3.77 | 7.1 |
| 89.2 | 3.59 | 4.0 | 87.9 | 5.07 | 5.8 |
| 175.6 | 7.37 | 4.2 | 143.8 | 9.77 | 6.8 |
| 297.5 | 8.57 | 2.9 | 268.0 | 9.36 | 3.5 |

## Conclusion:

Results of comparative nonclinical and clinical testing demonstrate that the performance of the ExacTech RSG Blood Glucose Testing System is comparable to the performance of the standard ExacTech Blood Glucose Testing System and suitable for its intended use.