ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM

K021943 · Lifescan, Inc. · CGA · Jun 28, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021943
• Device Name: ONETOUCH PROFILE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jun 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The ONETOUCH Profile Meter is used for the quantitative determination of glucose in whole blood by lay persons in the home and by medical professionals in clinical settings as an aid in monitoring effectiveness of diabetes management.

Device Story

OneTouch Profile Meter; portable glucose monitoring system. Input: whole blood sample. Operation: quantitative glucose measurement. Usage: home (lay persons) and clinical (medical professionals). Output: blood glucose concentration displayed on device screen. Clinical utility: aids monitoring of diabetes management effectiveness. Device modification: updated labeling to instruct users to verify display integrity prior to each test.

Indications for Use

Indicated for quantitative glucose measurement in whole blood for lay persons in home settings and medical professionals in clinical settings to aid diabetes management.

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.

Submission Summary (Full Text)

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'JUN 2 8 2002

K021943

# 510(k) SUMMARY

.

(As required by 21 C.F.R. § 807.92)

| Submitted By: | Lifescan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035 |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John E. Hughes<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary<br>Prepared: | June 20, 2002 |
| Device Name | ONETOUCH® Profile Meter |
| Classification | 862.1345 Glucose Test System |
| Description of the<br>Changed Labeling | The labeling of this device was modified to enhance instructions for<br>use advising users to insure the display is operating properly each<br>time they perform a test. |
| Statement of<br>Intended Use: | The ONETOUCH Profile Meter is used for the quantitative<br>determination of glucose in whole blood by lay persons in the home<br>and by medical professionals in clinical settings as an aid in<br>monitoring effectiveness of diabetes management. |
| Substantial<br>Equivalence: | The current labeling for this meter advises users to check that the<br>display is operating properly. The revised labeling clarifies that the<br>user should check the display integrity each time a test is<br>performed. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 2 8 2002

Mr. John E. Hughes Manager Regulatory Submissions LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

k021943 Re:

> Trade/Device Name: OneTouch® Profile Meter Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA Dated: May 24, 2002 Received: May 28, 2002

Dear Mr. Hughes:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmaldsmamain.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:

K021943

ONETOUCH® Profile Meter Device Name:

### Indications for Use:

The ONETOUCH® Profile Meter is used for the quantitative measurement of glucose in whole blood by lay persons in the home and by medical professionals in clinical settings as an aid in monitoring effectiveness of diabetes management.

Hap Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K021943

Concurrence of CDRH, Office of Device Evaluation

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use