ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM

K082513 · Lifescan, Inc. · NBW · Oct 22, 2008 · Clinical Chemistry

Device Facts

• Record ID: K082513
• Device Name: ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 22, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing 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 Vita™ 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 test strips and meter. User applies blood sample to test strip; meter performs electrochemical analysis; displays quantitative glucose result. Used by patients at home or healthcare professionals in clinical settings. Modifications from predicate include ergonomic design, removal of user coding step, and updated test strip electrode layout. Provides immediate feedback for diabetes management; aids in monitoring glycemic control.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of the modified features.

Technological Characteristics

Electrochemical glucose monitoring system. Components: meter, test strips, control solutions, lancing device, sterile lancets. Features modified electrode layout on test strips. Software/firmware updated to remove user coding requirement. Operates via capillary blood sample.

Indications for Use

Indicated for use by patients 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® Select™ Blood Glucose Monitoring System (K072543)
• OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529)

Submission Summary (Full Text)

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

K052513

Image /page/0/Picture/1 description: The image shows the LifeScan logo, which includes the word "LIFESCAN" in bold, sans-serif font. Below the word "LIFESCAN" is the phrase "a Johnson & Johnson company" in a smaller, lighter font. To the left of the word "LIFESCAN" is a graphic element that appears to be a stylized representation of a blood drop or a similar shape. The logo has a sleek and modern design.

OCT 2 2 2008

# OneTouch® Vita™ Blood Glucose Monitoring System

## 510(k) Summary

| Sponsor | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035 U.S.A. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Primary 510(k) Contact (submitter):<br>Oyinkan Donaldson<br>LifeScan Scotland Ltd.<br>Beechwood Park North<br>Inverness, IV2 3ED<br>United Kingdom<br>Phone: [phone]<br>e-mail: [e-mail]<br>Secondary 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® Vita™ Blood Glucose Monitoring System<br>Common name: Glucose test system<br>Classification:<br>(1) OneTouch® Vita™ Blood Glucose Meters and<br>OneTouch® Vita ™ Test Strips are Class II<br>devices<br>(21 CFR § 862.1345)<br>(2) OneTouch® Vita™ 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<br>Blood Sampler with OneTouch® UltraClear® Cap<br>and OneTouch® UltraSoft® Sterile Lancets are<br>Class I (exempt) devices (21 CFR § 878.4800) |

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

Image /page/1/Picture/0 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in bold, sans-serif font. Below the word is the text "johnson johnson company" in a smaller, cursive font. To the left of the word is a graphic of a globe with a curved line extending from the bottom left to the top right.

#### System Description

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

The OneTouch® Vita™ meter is a modification of the OneTouch® Select™ and OneTouch® Ultra®2 meters. The OneTouch® Vita™ test strip is a modification of the OneTouch® Ultra® test strip (component of the OneTouch® Ultra®2 Blood Glucose Monitoring System).

There are no changes to other system testing components compared to the predicate devices.

#### Predicate Devices - OneTouch® Select™ Blood Glucose Monitoring System (K072543, cleared 4th Oct 2007)

- OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529, cleared 17 Jan 2006)
#### Intended Use

The OneTouch® Vita™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch® Vita™ System is intended for self-testing 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 Vita™ Blood Glucose Monitoring System is specifically indicated for use on the finger, forearm or palm.

#### Comparison to Predicate Devices

The device modifications encompass:

- Meter ergonomic/physical design and software/firmware changes . including removal of user coding step
- Test Strip changes to electrode layout and cosmetic appearance .

The OneTouch® Vita™ Blood Glucose Monitoring System has the same intended use, material composition and operating principle as the predicate devices.

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

Image /page/2/Picture/0 description: The image shows the LifeScan logo, which includes the company name in bold, stylized letters. Below the company name, in smaller font, is the text "Johnson & Johnson company". To the left of the company name is a graphic element that appears to be a stylized globe or sphere with an arc extending from it.

#### Technological Characteristics

The OneTouch® Vita™ Blood Glucose Monitoring System has the same
fundamental scientific technology as the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra®2 Blood Glucose Monitoring System predicate devices.

#### Summary of Performance Characteristics

The OneTouch Vita™ Blood Glucose Monitoring System has the same performance characteristics as the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra 2 Blood Glucose Monitoring System predicate devices.

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

Design Verification testing (including software verification and validation testing) confirmed that the performance, safety, and effectiveness of the OneTouch® Vita™ Blood Glucose Monitoring System is equivalent to that of the predicate devices.

The modified blood glucose monitoring system (meter and test strip) 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 usability of the device (human factors) in the hands of intended users and validated comprehension of the proposed product labeling.

#### Conclusion

The OneTouch® Vita™ Blood Glucose Monitoring System is substantially equivalent to the OneTouch® Select™ Blood Glucose Monitoring System and OneTouch® Ultra®2 Blood Glucose Monitoring System predicate devices.

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

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure in black, with three distinct lines forming its body and wings. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 0 6 2008

LifeScan Inc. c/o Mrs. Ovinkan Donaldson 1000 Gibraltar Dr. Milpitas. CA 95035

k082513 Re: Trade Name: OneTouch Vita Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Codes: NBW, CGA Dated: September 18, 2008 Received: September 22, 2008

Dear Mrs. Donaldson:

This letter corrects our substantially equivalent letter of October 22, 2008.

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).

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

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

Sincerely yours,

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

Yéan 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

{5}------------------------------------------------

### Indications for Use

510(k) Number (if known): __<< 8 2s / 3

Device Name: OneTouch® Vita™ Blood Glucose Monitoring System

Indications For Use:

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

The OneTouch® Vita™ 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 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