ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM

K021819 · Lifescan, Inc. · NBW · Aug 23, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021819
• Device Name: ONE TOUCH ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart™ System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The One Touch® UltraSmart™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.

Device Story

System consists of meter, test strips, control solution, lancing device, and lancets. Meter measures glucose in capillary whole blood via test strips; provides electronic logbook for tracking insulin/medication doses, food, exercise, and illness. Used at home by patients or in clinical settings by professionals. Data port allows download of logbook information to personal computer for review. Facilitates diabetes management by providing expanded memory and data storage compared to predicate devices.

Clinical Evidence

Laboratory and clinical studies demonstrate performance equivalent to the One Touch Ultra Blood Glucose System.

Technological Characteristics

System includes meter, test strips, control solution, and lancing accessories. Glucose measurement via electrochemical detection (same as predicate). Features electronic logbook with data port for PC connectivity. No specific materials or software architecture details provided.

Indications for Use

Indicated for people with diabetes and healthcare professionals for quantitative measurement of glucose in fresh capillary whole blood to monitor diabetes control effectiveness.

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

• One Touch® Ultra™ Blood Glucose Monitoring System (K002134)
• One Touch® Profile® Blood Glucose Monitoring System (K950727)

Submission Summary (Full Text)

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## 510(k) SUMMARY

(As required by 21 C.F.R. § 807.92)

| | (As required by 21 C.F.R. § 807.92) |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K021819 |
| Submitted By: | Lifescan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035 |
| Contact Person: | Mary Ellen Holden<br>Senior Regulatory Affairs Specialist<br>Lifescan, Inc. |
| Date Summary | Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail]<br>June 3, 2002 |
| Prepared:<br>Device Name: | One Touch® UltraSmart™ Blood Glucose Monitoring System |
| Classification<br>Names: | (1) The One Touch® UltraSmart™ Meter and ONE TOUCH®<br>Ultra™ Test Strip are Class II devices (21 CFR § 862.1345,<br>Glucose Monitor).<br>(2) One Touch® Ultra™ Control Solution is a Class I device (21<br>CFR § 862.1660, Single Analyte Control).<br>(3) Sterile lancet, Lancing Device and accessories are Class I<br>(exempt) devices (21 CFR § 878.4800, Lancet, Blood). |
| Substantial<br>Equivalence: | The One Touch® UltraSmart™ Blood Glucose Monitoring System is<br>substantially equivalent to the previously cleared One Touch®<br>Ultra™ Blood Glucose Monitoring System (K002134), in that both<br>devices are intended for the quantitative measurement of glucose in<br>capillary whole blood (for in vitro diagnostic use) by people with<br>diabetes and healthcare professionals. Both devices use the<br>identical method of glucose detection and have the same safety and<br>effectiveness. In addition, it is substantially equivalent to the One<br>Touch® Profile® (K950727) Blood Glucose Monitoring System, a<br>predicate device with similar advanced memory features |
| Description of the<br>Device: | The One Touch® UltraSmart™ System consists of the One Touch®<br>UltraSmart™ Meter, One Touch® Ultra™ Test Strips, One Touch®<br>Ultra™ Control Solution, UltraSoft™ Lancing Device, UltraClear™<br>cap and UltraSoft™ lancets. The One Touch® UltraSmart™ Meter,<br>when used with the One Touch® Ultra™ Blood Glucose Test Strips,<br>quantitatively measures glucose in capillary whole blood. The One<br>Touch® Ultra™ Control Solution verifies the performance of the<br>One Touch® Ultra™ Blood Glucose Test Strips. |
| | The UltraSoft™ Lancing Device, UltraClear™ cap and UltraSoft™<br>lancets are provided to facilitate obtaining a capillary blood sample. |
| Statement of<br>Intended Use: | The One Touch® UltraSmart™ Blood Glucose Monitoring System is<br>intended to be used for the quantitative measurement of glucose in<br>fresh capillary whole blood. The One Touch® UltraSmart™ System<br>is intended for use outside the body (for <i>in vitro</i> diagnostic use) by<br>people with diabetes at home and by health care professionals in a<br>clinical setting as an aid to monitor the effectiveness of diabetes<br>control. |
| | The One Touch® UltraSmart™ Blood Glucose Monitoring System<br>provides the user with electronic logbook functions that store data<br>such as insulin and oral medication doses, food intake, amount of<br>exercise, and health information such as illnesses. The meter<br>includes a data port that enables the user to download electronic<br>logbook data to a personal computer |
| Description of<br>Similarities and<br>Differences: | The One Touch® UltraSmart™ System, provides the same glucose<br>monitoring capability as the predicate device, the One Touch®<br>Ultra™ System (K002134). One Touch® UltraSmart™ and One<br>Touch® Ultra™ are essentially identical from the perspective of<br>measuring glucose. In fact, they use the same One Touch Ultra™<br>test strip. The primary differences are in the advanced memory<br>features. In this respect, the One Touch® UltraSmart™ System adds<br>electronic logbook features similar to those offered commercially<br>by the One Touch® Profile Meter (K950727). |
| | The advanced memory features of One Touch® UltraSmart™ are<br>similar to those of the One Touch® Profile Meter previously cleared<br>for market (K950727). The One Touch® UltraSmart™ meter offers<br>more memory, which allows advanced features not available with<br>the predicate devices. The increased data storage expanded<br>memory offers more opportunities to people with diabetes in<br>managing their diabetes. |
| Summary of<br>Performance Data | Laboratory studies and clinical studies demonstrate that the One<br>Touch® UltraSmart™ Blood Glucose System provides equivalent<br>performance to the One Touch® Ultra™ Blood Glucose System. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 lines forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 3 2002

Ms. Mary Ellen Holden Sr. Regulatory Affairs Specialist LifeScan. Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

k021819 Re: Trade/Device Name: ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 3, 2002 Received: June 4, 2002

Dear Ms. Holden:

We have reviewed your 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 (QS) 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 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/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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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## 3.0 ODE INDICATIONS FOR USE STATEMENT

## Indications for Use Statement

| 510(k) Number: | K021819 |
|----------------|--------------------------------------------------------|
| Device Name: | ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System |

Indications for Use:

The One Touch® UltraSmart™ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The One Touch® UltraSmart" System is intended for use outside the body (for in vitro diagnostic use) by people with diabetes at home and by health care professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The One Touch® UltraSmari™ Blood Glucose Monitoring System provides the user with electronic logbook functions that store data such as insulin and oral medication doses, food intake, amount of exercise, and health information such as illnesses. The meter includes a data port that enables the user to download electronic logbook data to a personal computer.

Concurrence of CDRH, Office of Device Evaluation

| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter Use <span></span> |
|---------------------------------------|----|------------------------------------|
|---------------------------------------|----|------------------------------------|

Carol C Benson for Jean Cooper, DVM
(Division Sign-Off)
Division of Clinical Laboratory Devices

| 510(k) Number | KO21819 |
|---------------|---------|
|---------------|---------|

ONE TOUCH® UltraSmart™ Blood Glucose Monitoring System