MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM

K062195 · Lifescan, Inc. · NBW · Aug 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K062195
• Device Name: MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 16, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

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

Device Story

System measures glucose in fresh capillary whole blood; used by patients at home or clinicians in clinical settings. Device consists of meter, test strips, control solution, and blood sampler with lancets. User applies blood sample to test strip; meter performs electrochemical analysis to quantify glucose concentration. Output displayed on meter screen; aids in monitoring diabetes control. Modifications to predicate include meter hardware and firmware updates; electrical safety testing updated to ISO 15197:2003(E).

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to ensure P1 parameter stability following physical impact (dropping/jarring).

Technological Characteristics

Electrochemical glucose measurement. System includes meter, test strips, control solution, and blood sampler. Modifications include meter hardware and firmware updates. Electrical safety testing performed per ISO 15197:2003(E).

Indications for Use

Indicated for use by patients with diabetes for the quantitative measurement of glucose in capillary whole blood.

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® Blood Glucose Monitoring System (K062195)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the LifeScan logo, which includes the company name in bold, sans-serif font. Below the company name, in a smaller font, is the text "a Johnson & Johnson company". To the left of the company name is a circular graphic with a black swoosh above the company name.

K062195

# OneTouch® Ultra® Blood Glucose Monitoring System

# 510(k) Summary

AUG 16 2006

| Submitter | LifeScan, Inc.<br>1000 Gibraltar Drive |
|-------------|-------------------------------------------------------------|
| | Milpitas, CA 95035-6312 |
| | 510(k) Contact: Cindy Morrow, LifeScan, Inc. |
| | Alternate 510(k) Contact: Mary Ellen Holden, LifeScan, Inc. |
| Device Name | OneTouch® Ultra® Blood Glucose Monitoring System |
| | Common name: Glucose test system |
| | Classification: |
| | (1) OneTouch® Ultra® Blood Glucose Meters and |
| | OneTouch® Ultra® Test Strips are Class II devices |
| | (21 CFR § 862.1345) |
| | (2) OneTouch® Ultra® Control Solution is a Class I |
| | device (21 CFR § 862.1660) |
| | (3) OneTouch® UltraSoft® Adjustable Blood Sampler |
| | with OneTouch® ClearCap™ and OneTouch® |
| | UltraSoft® Sterile Lancets are Class I (exempt) devices |
| | (21 CFR § 878.4800) |

#### System Description

The OneTouch Ultra Blood Glucose Monitoring System consists of the OneTouch Ultra Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler with OneTouch ClearCap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® meter hardware and software has been modified. There are no changes to other system testing components compared to the currently marketed product.

OneTouch Ultra Blood Glucose Monitoring System Predicate Device

#### Intended Use

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

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Image /page/1/Picture/0 description: The image shows the logo for LifeScan, a Johnson & Johnson company. The logo features the word "LIFESCAN" in bold, sans-serif font, with the tagline "a Johnson & Johnson company" written in a smaller, italicized font underneath. To the left of the word "LIFESCAN" is a graphic element that appears to be a stylized globe or sphere. The logo has a sleek and professional design.

510(K) Summary, Page 2 of 2

#### Comparison to Predicate Device

The modifications to the device encompass meter hardware and software/firmware changes. The labeling has been updated to provide electrical safety testing certification in accordance with ISO 15197:2003(E). There has been no change to the intended use, operating principle, functionality, or material composition of the device.

### 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 system.

A system accuracy study demonstrated that the modified OneTouch Ultra Blood Glucose Monitoring System and the currently marketed OneTouch Ultra Blood Glucose Monitoring System are substantially equivalent.

Design Verification (including software verification and validation testing) confirmed that the performance, safety and effectiveness of the modified OneTouch Ultra Blood Glucose Monitoring System were equivalent with that of the predicate device.

The modified meter was tested in accordance with ISO 15197:2003(E) including system accuracy and electrical safety testing. In addition, testing was performed to verify the effectiveness of the changes to the meter hardware and software.

#### Conclusion

The modified OneTouch Ultra Blood Glucose Monitoring System is substantially equivalent to the predicate OneTouch Ultra Blood Glucose Monitoring 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

AUG 1 6 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cindy Morrow Sr. Regulatory Submission Specialist LifeScan. Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

Re: k062195

Trade/Device Name: OneTouch® Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 31, 2006 Received: August 1, 2006

Dear Ms. Morrow:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I mo ichet 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

Alberto Guts

Alberto Gutierrez, Ph.D. 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): K06 x \ (5

Device Name: OneTouch® Ultra® Blood Glucose Monitoring System

Indications For Use:

The OneTouch Ultra Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra System is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and/or by healthcare dragmootic as an aid to monitor the effectiveness of diabetes control.

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

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

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

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