ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM

K072543 · Lifescan, Inc. · NBW · Oct 5, 2007 · Clinical Chemistry

Device Facts

• Record ID: K072543
• Device Name: ONETOUCH SELECT BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 5, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The OneTouch® Sclect™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Select™ System is intended for self-testing outside the body (in vitro diagnostic use) by pcople 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® Select™ 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; consists of meter, test strips, control solutions, and lancing device. User applies blood sample to test strip; meter performs electrochemical analysis to quantify glucose concentration. Used by patients at home or clinicians in clinical settings. Output displayed on meter screen to aid diabetes management. Modifications from predicate include ergonomic/physical design, hardware/firmware updates, electrode layout changes, and addition of second control solution level.

Clinical Evidence

No clinical data provided. Substantial equivalence established via design control activities, risk analysis, and verification/validation testing of modifications.

Technological Characteristics

Electrochemical glucose monitoring system. Components: meter, test strips, control solutions, lancing device. Modifications include updated ergonomic design, hardware/firmware, and electrode layout. Complies with ISO 15197:2003(E) for analytical performance.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for people with diabetes (home use) and healthcare professionals (clinical setting) to monitor diabetes control. 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.

Predicate Devices

• OneTouch® Ultra® 2 Blood Glucose Monitoring System (K072543)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the LifeScan logo, which is a black oval shape with the words "LIFESCAN" in bold, black letters. Below the company name is the text "Johnson & Johnson company" in a smaller font. The logo is simple and modern, and the use of black and white gives it a clean and professional look. The logo is likely used to represent the company and its products.

0CT 5 * 2007

# 0 neTouch® Select™ Blood GlucoseM onitoring System

510 k) Sum m ary

K072543

| Sponsor | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035 U.S.A. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Primary 510(k) Contact:<br>Alison Wilson<br>LifeScan Scotland Ltd.<br>Beechwood Park North<br>Inverness, IV2 3ED<br>United Kingdom<br><br>Phone: [phone]<br>e-mail: [e-mail]<br><br>Alternate 510(k) Contact:<br>Mary Ellen Holden<br>LifeScan Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035 U.S.A.<br>Phone: [phone]<br>E-mail: [e-mail] |
| Device Name and<br>Classification | OneTouch® Select™ Blood Glucose Monitoring System<br>Common name: Glucose test system<br>Classification:<br>(1) OneTouch® Select™ Blood Glucose Meters and<br>OneTouch® Select™ Test Strips are Class II devices<br>(21 CFR § 862.1345)<br>(2) OneTouch® Select™ Control Solutions are a Class I<br>device (21 CFR § 862.1660)<br>(3) OneTouch® Lancing Device with OneTouch® AST<br>ClearCap™, OneTouch® UltraSoft® Adjustable Blood<br>Sampler with OneTouch® UltraClear® Cap and<br>OneTouch® UltraSoft® Sterile Lancets are Class I<br>(exempt) devices (21 CFR § 878.4800) |

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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, black letters. Below the company name is the text "a Johnson & Johnson company" in a smaller font. The logo also includes a graphic element that resembles a stylized orbit around the company name.

## System Description

The OneTouch® Select™ Blood Glucose Monitoring System consists of the OneTouch® Select™ Meter, OneTouch® Select™ Test Strips (provided separately), OneTouch® Select™ Control Solution (provided separately), OneTouch® Select™ High Control Solution (provided separately), either the OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap or the OneTouch® Lancing Device with Onc Touch® AST ClearCap and OneTouch® UltraSoft Sterile Lancets.

The OneTouch® Select™ meter, test strip and high control solution are modifications of the OneTouch Ultra 2® meter, test strip and normal control solution, respectively.

There are no changes to other system testing components compared to the currently marketed product.

Predicate Device OneTouch® Ultra® 2 Blood Glucose Monitoring System

## Intended U se

The OneTouch® Sclect™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Select™ System is intended for self-testing outside the body (in vitro diagnostic use) by pcople 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® Select™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

# C om parison to Predicate D evice

The modifications to the device encompass:

- . M eter : ergonomic/physical design, electronic/hardware, software/firmware changes.
- . Test Strip: changes to appearance and layout of electrodes
- ControlSolution : availability of a second level of control .

There has been no change to the intended use, operating principle, functionality, or material composition of the device.

#### Technological C haracteristics

There has been no change to the fundamental scientific technology.

#### Summary of Perform ance Characteristics

There has been no change to the performance characteristics of the system.

A comparison of system accuracy performance demonstrated that the OneTouch® Select™ Blood Glucose Monitoring System and the currently marketed OneTouch Ultra 2 Blood Glucose Monitoring System are substantially equivalent.

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Design Verification testing (including software verification and validation testing) Dosign Vormediten working (more and effectiveness of the OneTouch® Select™ economical mae Monitoring System were equivalent to that of the predicate device.

The modified blood glucose monitoring system (meter, strips, and control) was tested in accordance with ISO 15197:2003(E). Analytical performance testing included system accuracy, repeatability and intermediate precision testing. A User performance evaluation assessed accuracy of results and usability of the device (human factors) in the hands of intended users. In addition, comprehension of the proposed product labeling was validated.

#### C onclusion

The OneTouch® Sclect™ Blood Glucose Monitoring System is substantially equivalent to the predicate OneTouch Ultra 2 Blood Glucose Monitoring System.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

LifeScan, Inc. c/o Ms. Alison Wilson Regulatory Affairs Specialist 1000 Gibraltar Drive Milpitas, CA 95035-6312

OCT 5 2007

Re: k072543

Trade/Device Name: OneTouch® Select™ Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: September 07, 2007 Received: September 10, 2007

Dear Ms. Wilson:

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) 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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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): ____________________________________________________________________________________________________________________________________________________

Device Name: OneTouch® Select™ Blood Glucose Monitoring System

Indications For Use:

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

The OneTouch Select 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)

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

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| 510(k) | k072543 |