ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM

K043197 · Lifescan, Inc. · CGA · May 20, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043197
• Device Name: ONETOUCH ULTRA, INDUO AND ULTRASMART BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: May 20, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The OneTouch® Ultra® Family of Systems are intended to be used for quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra Family of Systems are intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch Ultra Family of Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.

Device Story

System uses glucose oxidase biosensor test strips and reflectance photometer to measure capillary blood glucose. User applies blood to strip; reagents generate electrical current proportional to glucose concentration; meter calculates and displays result. Used by patients at home or clinicians in clinical settings. Provides quantitative glucose readings to aid diabetes management. Includes electronic logbook (UltraSmart) and integrated insulin dosing cap (InDuo). Palm testing requires steady-state conditions; fingertip testing preferred for rapid glucose changes or suspected hypoglycemia. Data port allows download to PC for analysis.

Clinical Evidence

Clinical testing demonstrated that palm and finger glucose measurements are equivalent during steady state. No other clinical data provided; performance characteristics remain unchanged from predicate devices.

Technological Characteristics

In vitro diagnostic system; glucose oxidase electrochemical biosensor; reflectance photometer; capillary blood sample; data management software; PC connectivity via data port; integrated insulin doser (InDuo model); electronic logbook (UltraSmart model).

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for people with diabetes at home or clinical settings. Specifically indicated for use on finger, arm, or palm. Contraindicated for palm testing if glucose is rapidly changing (e.g., within 2 hours of meals, exercise, or rapid-acting insulin) or if hypoglycemia is suspected.

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

• OneTouch® Ultra® Test Strip (K043197)
• OneTouch® Ultra® Blood Glucose Monitoring System (K043197)
• OneTouch® InDuo® Blood Glucose Monitoring System (K043197)
• OneTouch® UltraSmart® Blood Glucose Monitoring System (K043197)

Submission Summary (Full Text)

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Koy3197

MAY 2 0 2005

# 510(k) Summary

| Submitter | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035 |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | John E. Hughes<br>Phone: [phone]<br>Fax: [phone]<br>E-mail:[e-mail] |
| Date Summary Prepared | May 18, 2005 |
| Classification Name | (1) OneTouch® Ultra® Test Strip and OneTouch® Ultra®<br>Family of Blood Glucose Monitoring Systems (OneTouch®<br>Ultra®, OneTouch® InDuo® and OneTouch® UltraSmart®)<br>Common name: Glucose test system<br>Classification: Blood Glucose Meters and Test Strips are Class<br>II devices (21 CFR Section 862.1345, Glucose Test System)<br>(2) OneTouch Ultra Control Solution is a Class I device (21<br>CFR Section 862.1660, Single Analyte Control.)<br>(3) UltraSoft Blood Sampler and Sterile Lancet - Sterile<br>Lancet, Lancing Device and accessories are Class I (exempt)<br>devices (21 CFR Section 878.4800, Lancet, Blood. |
| Predicate Devices | OneTouch® Ultra® Test Strip<br>OneTouch® Ultra® Blood Glucose Monitoring System<br>OneTouch® InDuo® Blood Glucose Monitoring System<br>OneTouch® UltraSmart® Blood Glucose Monitoring System |

#### Device Description

Device Description
The OneTouch Family of Systems consists of the OneTouch Ultra, InDuson UltraSmart The OneTouch Ultra Test Strips, OneTouch Ultra Control Solution, UltraSoft Lancing Meter, Olici Ouch Othu Pet Strips, Olancets. The OneTouch Ultra meter, when used with Device, OnlaCical Cap and Oliudon anteters - quantitatively measures glucose in capillary the One Touch Offica Blood Chacose Fest Solution verifies the performance of the OneTouch Ultra Blood Glucose Test Strips.

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### Intended Use

The OneTouch® Ultra® Family of Systems are intended to be used for quantitative The One Touch® Otha® Family of Systems are and and million in the OneTouch Ultra Family of illeasurenced on gracese in ness cap the body (in viro diagnostic use) by people with Systems are intentious for the store professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch Ultra Family of Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.

### Comparison to Predicate Device System

The modifications to the OneTouch Ultra Family of systems encompass changes to the intended use (and associated labeling changes) for the OneTouch Ultra Test Strips. The intended use (and assocexpanded to include palm testing. The labeling has been modified to expand the Alternative Site Testing (AST) sites to include the palm of the hand. Clinical testing demonstrated that palm and finger glucose measurements are equivalent during the steady state. In addition, incremental changes to the device systems have been addressed.

### Technological Characteristics

There has been no change to the fundamental scientific technology.

### Summary of Performance Characteristics

There has been no change to the performance characteristics of the device systems.

#### Conclusion

The modified intended used and associated labeling changes for the OneTouch Ultra Test Strip and OneTouch Family of Blood Glucose Monitoring Systems are substantially equivalent to the predicate devices.

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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 and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The words "HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

MAY 2 0 2005

k043197 Re:

K043177
Trade/Device Name: OneTouch® Ultra® Blood Glucose Monitoring System OneTouch® InDuo® Blood Glucose Monitoring System OneTouch® IIIDaos 2100 Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CGA, NBW Dated: April 19, 2005 Received: April 20, 2005

Dear Ms. Holden:

We have reviewed your Section 510(k) premarket notification of intent to market the device in we nave reviewed your Section 510(x) premainer's substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regarry to regally in the Medical Device American Comments, or to connierce phor to May 20, 1970, are excordance with the provisions of the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval app alle Cosment Act (Act) that to not require appro the general controls provisions of the Act. The 1 ou may, mercetore, market the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), if your device is classified (360 a00 vb) inrols. Existing major regulations affecting your device It may be subject to Such additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 can oc found in Title 21, Courseling your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance or a baces complies with other requirements of the Act
that FDA has made a determination that your device complies with other requiremen that IDA has made a decemination administered by other Federal agencies. You must of ally if cue al statutes and regulations adminities out not limited to: registration and listing (21 comply with an the Her S require.Roms 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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#### Page 2 - .

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maneting your antial equivalence of your device to a legally premits the results in the PDF intuing of cast....... for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific information acround in a prour device, please contact the Office of In of questions on the promotion and Safety at [phone]. Also, please note the VINO Diagnostic Device Dranding by reference to premarket notification" (21CFR Part 807.97). regulation childed, "Misorananting of responsibilities under the Act from the You may outlif onlier general information on your respected at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K043197

Device Name: OneTouch® Ultra® Blood Glucose Monitoring System

Indications for Use:

The OneTouch® Ultra® Blood Glucose Monitoring System is intended to be used for quantiative The OneTouch® Ultra® Blood Chacose Momornig of steem oneTouch® Ultra® System is intended
measurement of glucose in fresh capillary whole blood. The One and healthcare measurement of glucose in nesn capilary whole block. I with diabetes at home and healthcare
for use outside the body (in virro diagnostic use) by people of dispetes control for use outside the body (in wird diagnostic ase) by poople with the effectiveness of diabetes control.

The OneTouch® Ultra® Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.

Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of 1

Updated August 30, 2004

Nlote Ziz C

Division Sign-Of

Office of In Vitro Diagnostic Device Evaluation and Safet

510(k) k043197

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## Indications for Use

510(k) Number (if known): K043197

Device Name: OneTouch® InDuo® Blood Glucose Monitoring System

Indications for Use:

The OneTouch® InDuo® System is intended to be used for quantitative measurement of glucose in The One I ouch® InDuble System is intended to be assesser is intended for use outside the body fresn capillary whole blood. The One robeits of class of cases of theather professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch® InDuo® Blood Glucose Meter also functions as the cap for the InDuo® Insulin The Oller ouch of InDuce BROGE er to form a single unit for user convenience.

The OneTouch InDuo® Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __X (21 CFR 801 Subpart C)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Page 1 of 1

Updated August 30, 2004

Alberto
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k043197

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## Indications for Use

510(k) Number (if known): K043197

Device Name: OneTouch® UltraSmart® Blood Glucose Monitoring System

Indications for Use:

The OneTouch® UltraSmart® System is intended to be used for quantitative measuement of The OneTouch® UtraSmart® System is intended to be astem intended for use outside
glucose in fresh capillary whole blood. The One his and healtheare wofessionals in a glucose in fresh capillary Whole blood. The One of Inc. one and healthcare professionals in a
the body (in vitro diagnostic use) by people with diabetest in a the body (in viro diagnostic doo) of post property.
clinical setting as an aid to monitor the effectiveness of diabetes control.

The OneTouch UltraSmart® Blood Glucose Monitoring System provides the user with electronic The OneTouch UltraSmart® Blood Shacose Moulin and oral medication doses, food intake, amount of logbook functions that store data such as illisum and our meeted includes a data port that enables the user to download electronic data to a personal computer.

The OneTouch® UltraSmart® Smart Blood Glucose Monitoring System is specifically indicated for use on the finger, arm or palm.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _X_______________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

Concurrence of CDRH, Qffice of In Vitro Diagnostic Devices (OIVD)

Page 1 of 1

Alberts S
Division Sign-Off

Division Sign-Off

Updated August 30, 2004

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) ko4/3/97