ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM

K053529 · Lifescan, Inc. · NBW · Jan 17, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053529
• Device Name: ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jan 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 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 2 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; utilizes meter, test strips, control solution, and blood sampler. Designed for home use by patients or clinical use by professionals to monitor diabetes control. Modifications to predicate include updated meter software/firmware, ergonomic/physical design, and hardware changes. Operates via electrochemical sensing technology consistent with predicate. Provides quantitative glucose results to assist in clinical decision-making and diabetes management.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements to confirm modifications met predetermined acceptance criteria.

Technological Characteristics

Electrochemical glucose measurement; consistent with predicate technology. Includes meter, test strips, control solution, and adjustable blood sampler. Modifications involve ergonomic/physical design and software/firmware updates. No changes to fundamental scientific technology or material composition.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for individuals with diabetes at home or by healthcare professionals in clinical settings. Indicated for use on finger, forearm, or palm.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the LifeScan logo, which includes a stylized globe and the company name in bold, sans-serif font. Below the company name, it says "a Johnson & Johnson company" in a smaller, italicized font. The logo has a swoosh design element above the company name, adding a dynamic visual element to the overall design. The logo is in black and white.

K053529

IAN 17

# OneTouch® Ultra® 2 Blood Glucose Monitoring System

# 510(k) Summary

| Submitter | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035-6312<br>Contact: Lisa McGrath<br>Date Prepared: December 16, 2005 |
|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | OneTouch® Ultra® 2 Blood Glucose Monitoring System<br>Common name: Glucose test system<br>Classification:<br>(1) OneTouch® Ultra® 2 Blood Glucose Meters and<br>OneTouch® Ultra® Test Strips are Class II devices (21<br>CFR § 862.1345)<br>(2) OneTouch® Ultra® Control Solution is a Class I<br>device (21 CFR § 862.1660)<br>(3) OneTouch® UltraSoft® Adjustable Blood Sampler and<br>Sterile Lancets are Class I (exempt) devices (21 CFR § |

# System Description

The OneTouch Ultra 2 Blood Glucose Monitoring System consists of the OneTouch Ultra 2 Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch UltraSoft Blood Sampler and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch Ultra 2 Meter; there are no changes to other system testing components compared to the currently marketed product.

878.4800)

OneTouch Ultra Blood Glucose Monitoring System ( Ko2 4 194 ) Predicate Device

# Intended Use

The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 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 2 Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

{1}------------------------------------------------

### 510(K) Summary, Page 2

#### Comparison to Predicate Device

The modifications to the device encompass meter software/firmware, ergonomic/physical design, hardware and labeling changes. 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 meter equivalence study demonstrated that the OneTouch® Ultra® 2 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 OneTouch Ultra 2 Blood Glucose Monitoring System was equivalent with that of the predicate device.

The modified meter was tested in accordance with ISO 15197:2003(E) including a consumer evaluation to assess ease of use (human factors and user acceptance). In addition, reading level assessment of the product labeling was conducted and validated for comprehension.

# Conclusion

The modified OneTouch Ultra 2 Blood Glucose Monitoring System is substantially equivalent to the predicate OneTouch Ultra Blood Glucose Monitoring System.

{2}------------------------------------------------

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 its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white and appears to be a simple, vectorized design.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 7 2006

Ms. Lisa G. McGrath Regulatory Project Leader LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

k053529 Re:

Trade/Device Name: OneTouch® Ultra® 2 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: December 17, 2005 Received: December 19, 2005

Dear: Ms. McGrath

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).

{3}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 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 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 vours,

Alberto G. A.

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

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): K053529

Device Name: OneTouch® Ultra® 2 Blood Glucose Monitoring System

Indications For Use:

The OneTouch Ultra 2 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch Ultra 2 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 2 Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

Prescription Use × (Part 21 CFR 801 Subpart D)

Image /page/4/Picture/7 description: The image shows the text "AND/OR" with the "AND" portion of the text circled. The text is written in a simple, sans-serif font. The circle around "AND" is hand-drawn and slightly irregular. The image appears to be a simple, possibly hand-drawn, graphic.

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Page 1 of 1

Albert Sevy
Division Sign-Off

Office of 1 a Vitro Diagnostic Device Evaluation and Salery

10(k) ........................................................................................................................................................................