ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM

K061118 · Lifescan, Inc. · NBW · May 19, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061118
• Device Name: ONETOUCH ULTRAMINI BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 19, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The OneTouch UltraMini Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. The OneTouch UltraMini 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 UltraMini 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 for in vitro diagnostic use. Operated by patients at home or healthcare professionals in clinical settings. Device is a modified version of the OneTouch Ultra Blood Glucose Monitoring System, featuring ergonomic, physical, electronic, and firmware updates. Input consists of blood sample applied to test strip; meter processes signal to provide quantitative glucose concentration. Output displayed to user to aid in diabetes management and monitoring effectiveness of control. No changes to fundamental scientific technology or operating principles compared to predicate.

Clinical Evidence

No clinical data provided; substantial equivalence supported by design control activities, risk analysis, and verification/validation testing of physical, electronic, and software modifications.

Technological Characteristics

Glucose test system; electrochemical sensing principle. Components: meter, test strips, control solution, lancing device. Modifications include ergonomic/physical design, electronic/hardware, and software/firmware. No change to fundamental scientific technology. Connectivity/software details not specified beyond firmware updates.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for people with diabetes at home or healthcare professionals in clinical settings 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 Blood Glucose Monitoring System

Submission Summary (Full Text)

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K061118

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# OneTouch® UltraMini™ Blood Glucose Monitoring System

## 510(k) Summarv

Submitter

LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312

510(k) Contact Name: Mary Ellen Holden, Regulatory Project Leader. LifeScan. Inc. [phone] or E-Mail: [e-mail]

510(k) Prepared by: Alison Wilson, Regulatory Specialist, LifeScan Scotland Limited

OneTouch® UltraMini™ Blood Glucose Monitoring System Common name: Glucose test system

Classification:

- (1) OneTouch® UltraMini™ 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® Lancing Device with ASTTM Clear Cap, OneTouch® UltraSoft® Adjustable Blood Sampler with OneTouch® UltraClear® Cap and OneTouch® UltraSoft® Sterile Lancets are Class I (exempt) devices (21 CFR § 878.4800)

#### System Description

The OneTouch UltraMini Blood Glucose Monitoring System consists of the OneTouch UltraMini Meter, OneTouch Ultra Test Strips (provided separately), OneTouch Ultra Control Solution, OneTouch Lancing Device with AST Clear Cap or OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap and OneTouch UltraSoft Sterile Lancets. The predicate OneTouch® Ultra® Meter has been modified to produce the OneTouch UltraMini Meter. The OneTouch Lancing Device with AST Clear Cap is a modification (smaller size) of the existing OneTouch UltraSoft Blood Sampler with OneTouch UltraClear Cap (class I, exempt device). There are no changes to any of the other system testing components compared to the currently marketed product.

#### Predicate Device

OneTouch Ultra Blood Glucose Monitoring System

Device Name

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510(K) Summary, Page 2

#### Intended Use

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

#### Comparison to Predicate Device

The modifications to the device encompass meter ergonomic/physical design, electronic/hardware, software/firmware and labeling changes. There has been no change to the intended use, fundamental scientific technology, operating principle, or essential functionality 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 UltraMini 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 UltraMini 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, Clinical Accuracy, and 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 UltraMini 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/2 description: The image shows a logo for the Department of Health & Human Services, USA. The logo features a stylized human figure with three arms reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the figure.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 19 2006

LifeScan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035-6312 Attn: Mary Ellen Holden, Regulatory Project Leader

Re: k061118

> Trade/Device Name: One-Touch® UltraMini™ Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: April 20, 2006 Received: April 21, 2006

#### Dear Ms. Holden:

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

Sincerely yours,

Alberto G

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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510(k) Number (if known): KOG // /8

Device Name: OneTouch® UltraMini™ Blood Glucose Monitoring System

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Indications For Use:

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

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(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

Carol C. Benson

**Office of In Vitro Diagnostic Device Evaluation and Safety**

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