FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM

K992684 · Abbott Diabetes Care, Inc. · LFR · Jan 14, 2000 · Clinical Chemistry

Device Facts

• Record ID: K992684
• Device Name: FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Abbott Diabetes Care, Inc.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TheraSense FreeStyle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh whole capillary blood. The FreeStyle System is intended for use outside the body (in vitro diagnostic use) by health care professionals and people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and it is not intended for use on neonates or with arterial blood samples.

Device Story

System consists of handheld meter, electrochemical biosensor test strips, and lancing device. User inserts strip; touches strip to blood drop (finger or arm); capillary action fills chamber (0.3 microliters). Glucose dehydrogenase enzyme reacts with blood glucose to produce electrical current; meter measures current; displays glucose concentration on LCD. Used by patients at home or clinicians in point-of-care settings. Provides quantitative results to assist in diabetes management; enables monitoring of glycemic control. Benefits include small sample volume requirement and alternative site testing.

Clinical Evidence

Multi-center controlled clinical study compared FreeStyle system to FastTake and standard laboratory methods. Evaluated accuracy and precision in lay users with diabetes and experienced technicians. Clarke Error Grid Analysis confirmed clinically acceptable accuracy. Results showed equivalent performance between lay users and trained technicians, and correlation with laboratory methods.

Technological Characteristics

Electrochemical biosensor glucose reagent test strip; glucose dehydrogenase enzyme methodology; handheld meter with LCD; capillary action sample intake; 0.3 microliter sample volume; finger or arm testing sites.

Indications for Use

Indicated for quantitative glucose measurement in fresh whole capillary blood from finger or arm. For use by people with diabetes mellitus at home or healthcare professionals to monitor diabetes control. Not for neonates, arterial blood, or diagnosis/screening of diabetes.

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

• FastTake (K970707)
• Accu-Chek Advantage with Comfort Curve Test Strips (K930979, K980731, K982002)
• AtLast (K982076)

Submission Summary (Full Text)

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TheraSense Inc.

K992684

JAN 1 4 2000

Image /page/0/Picture/4 description: The image shows the logo for TheraSense. The logo features a stylized human figure with outstretched arms, forming the letter 'S'. To the right of the figure is the word "THERASENSE" in bold, sans-serif font. Below the company name is the tagline "The Technology of Caring" in a smaller, italicized font.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is Not Assigned

### 1. Device Name

| Classification Name: | Glucose Test System (§ 862.1345) |
|----------------------|---------------------------------------------|
| Common/Usual Name: | Blood Glucose Meter and Reagent Test Strips |
| Proprietary Names: | FreeStyle™ Blood Glucose Monitoring System |

#### Legally Marketed Devices to which 2. Substantial Equivalence is Claimed:

| Predicate Device | 510(k) number |
|-------------------------------------------------------|-------------------------------|
| FastTake | K970707 |
| Accu-Chek Advantage with Comfort Curve Test<br>Strips | K930979<br>K980731<br>K982002 |
| AtLast | K982076 |

# 3. Device Description

The FreeStyle Blood Glucose Monitoring System comprises an electrochemical biosensor glucose reagent test strip, a handheld meter, a quality control solution, a complete Owner's

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..

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TheraSense Inc.

Booklet and a Quick Reference Guide. A lancing device, lancets and a logbook for recording test results are also included with the system.

When the user inserts a test strip, the meter turns on. The user acquires a blood sample (with the test strip in the meter) by picking up the meter and touching the edge of the test strip at the blood target area, filling the chamber on the strip by capillary action. The meter sounds a tone (beeps) to let the user know that the sample chamber is full and the reaction has begun. When the test is complete, the meter displays the glucose reading on its liquid crystal display (LCD).

### 4. Intended Use of the Device

The TheraSense FreeStyle Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh whole capillary blood. The FreeStyle System is intended for use outside the body (in vitro diagnostic use) by health care professionals and people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for use in the diagnosis of or screening for diabetes mellitus and it is not intended for use on neonates or with arterial blood samples.

### 5. Principle of Operation

The user obtains a blood sample using a conventional lancing technique on the finger or arm. The user inserts a test strip into the meter, which turns the meter on. When the strip is touched to the blood drop, the sample chamber on the strip fills by capillary action in approximately 2 seconds. The blood sample volume required is approximately 0.3 microliters (300 nanoliters), which can be obtained from the finger or other areas of the body such as the arm. Test results are displayed in about 15 seconds. The time required to display test results varies depending on the blood glucose concentration (approximately 15 to 45

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..

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seconds).

The glucose in the blood sample reacts with the glucose dehydrogenase enzyme to yield gluconolactone, and produces a small electrical current. This current is measured by the FreeStyle meter and displayed as a glucose level.

### 6. Summary of Data Demonstrating Substantial Equivalence

Performance testing of the FreeStyle Blood Glucose Monitoring System demonstrated that the system meets the performance requirements for its intended use. Laboratory testing was conducted in accordance with FDA draft guidance "Review Criteria for Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology. The results demonstrate that the FreeStyle Blood Glucose Monitoring System satisfies all performance requirements.

A multi-center controlled clinical study was conducted to demonstrate accuracy and precision of the FreeStyle System when used by lay users with diabetes mellitus and by experienced technicians. Blood glucose results obtained with FreeStyle and with the predicate device, FastTake were compared to a standard laboratory test for measuring blood glucose.

The clinical data demonstrate that the performance of FreeStyle correlates well with the laboratory method. When the blood glucose results were analyzed by the Clarke Error Grid Analysis, the System produced results within the range of clinical acceptable accuracy. The data also demonstrate that the FreeStyle performs equivalently to the predicate device, FastTake. The data also demonstrate that the system performs equivalently in the hands of the lay user and a trained technician.

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### 7. Conclusions Drawn from Nonclinical and Clinical Tests

Laboratory and clinical studies demonstrate that the TheraSense FreeStyle Blood Glucose Monitoring System is equivalent to the FastTake Blood Glucose Monitoring System and is safe and effective for its intended use.

Proprietary Data: This document and the information contained herein may not be reproduced, used or disclosed without prior written consent of TheraSense, Inc..

000368

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, which is a common symbol associated with medicine and healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 4 2000

Eva A. Conner, Ph.D. Vice President, Ouality Assurance/Regulatory Affairs Therasense. Inc. 1360 South Loop Road Alameda, California 94502

Re: K992684

> Trade Name: FreeStyle™ Blood Glucose Monitoring System Regulatory Class: II Product Code: LFR Dated: November 8, 1999 Received: November 9, 1999

Dear Dr. Connor:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D, M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

### 510(k) Number: K992684

Device Name: FreeStyle™ Blood Glucose Monitoring System

#### Indications for Use:

The TheraSense Inc. FreeStyle™ Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh whole capillary blood. It is intended for use by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The FreeStyle "" System is intended for use outside the body (in vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and it is not intended for use on neonates (newborns) or arterial blood.

The FreeStyle Blood Glucose Monitoring System is specifically indicated for use on the finger or arm.

Cospes
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992684

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-the-Counter Uses

unter Uses

(Per 21 CFR 801.109)