ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM

K073231 · Lifescan, Inc. · NBW · Apr 18, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073231
• Device Name: ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OneTouch® UltraLink™ Blood Glucose Monitoring System is intended to be used for self-testing outside the body (in vitro diagnostic use) for the quantitative measurement of glucose in fresh capillary whole blood obtained from the finger, forearm or palm. The OneTouch® UltraLink™ System is intended for use by people with diabetes in a home setting and by healthcare professionals in a clinical setting as an aid to monitor the effectiveness of diabetes control. The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

Device Story

System measures glucose in fresh capillary whole blood via test strips; provides quantitative results. Modification of OneTouch Ultra 2; adds radio-frequency (RF) telemetry to transmit glucose values to compatible Medtronic MiniMed Paradigm and Guardian REAL Time devices. Used by patients at home or clinicians in clinical settings. Healthcare providers use output to assess diabetes control effectiveness. Benefits include automated data transfer to compatible insulin pump/CGM systems, facilitating diabetes management.

Clinical Evidence

Bench testing per ISO 15197:2003. Precision and accuracy evaluated; 95% of results within ±15 mg/dL (at <75 mg/dL) or ±20% (at ≥75 mg/dL) of reference. Linearity confirmed per CLSI/NCCLS EP-6A. Human factors/performance studies at two U.S. clinical sites confirmed equivalent ability for lay and professional users to obtain suitable results.

Technological Characteristics

Glucose test system; electrochemical sensing. Includes meter, test strips, control solution, lancing device, lancets. Features RF telemetry for data transmission. Complies with ISO 15197:2003 for precision, accuracy, and safety. Linearity per CLSI/NCCLS EP-6A.

Indications for Use

Indicated for people with diabetes in home settings and healthcare professionals in clinical settings for quantitative measurement of glucose in fresh capillary whole blood (finger, forearm, palm). Not for neonatal use, screening/diagnosis of diabetes, or critically ill/hyperosmolar patients. Alternative site testing only during steady state.

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 (K053529)
• BD Paradigm Link® Blood Glucose Monitor (K040603)

Submission Summary (Full Text)

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K073231

APR 1 8 2008

## 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §807.92

| Submitted by: | LifeScan, Inc.<br>1000 Gibralter Ave.<br>Milpitas, CA. 95035 |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kim Fonda<br>Senior Regulatory Affairs Specialist<br>Phone: [phone]<br>FAX: [phone]<br>E-Mail: [e-mail] |
| Summary Date: | November 14, 2007 |
| Trade Name: | OneTouch ^® UltraLink ^™ Blood Glucose Monitoring System |
| Common Name: | Blood Glucose Monitor |
| | Device Classification: Class II, Glucose Test System (21 CFR §862.1345, Product Code NBW) |

### Substantial Equivalence

The OneTouch® UltraLink™Blood Glucose Monitoring System is substantially equivalent to the OneTouch® Ultra®2 Blood Glucose Monitoring System as cleared under K053529. Both devices have a similar intended use, measure the same sample type and have similar performance characteristics. The OneTouch® UltraLink™ Blood Glucose Monitoring System is substantially equivalent to the BD Paradigm Link® Blood Glucose Monitor as cleared under K040603 for the ability to transmit blood glucose results using Radio-Frequency telemetry.

### Device Description

The OneTouch® UltraLink Blood Glucose Monitoring System is a modification to the OneTouch® Ultra® 2 Blood Glucose Monitoring System, retaining the features, functions, and user interface of the OneTouch® Ultra® 2 meter while introducing a feature allowing Radio-Frequency transmission of blood glucose results to compatible Medtronic MiniMed, Inc. devices. The OneTouch® UltraLink™ Blood Glucose Monitoring System is composed of the OneTouch®

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UltraLink™ Blood Glucose meter, OneTouch® Ultra® Test Strips, OneTouch® Ultra® Control Solution, OneTouch® Lancing device, OneTouch® UltraSoft® Lancets, and meter carrying case. System modifications were made only to the blood glucose meter, carrying case, and instructions for use.

### Intended Use

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

| Predicate Device | Similarities to Subject Device | Differences between Subject<br>Device<br>(Modifications) |
|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| OneTouch® Ultra®2 Blood<br>Glucose Monitoring System<br>(K053529)<br>Quantitative measurement<br>of blood glucose | Same intended use<br>Same sample type<br>Same fundamental scientific<br>technology<br>Same system components | Meter: ergonomic/physical<br>design, electronic/hardware,<br>software/firmware.<br>Instructions for use - addition of<br>Radio Frequency use information |
| BD Paradigm Link® Blood<br>Glucose Monitor<br>(K040603)<br>Radio-Frequency<br>transmission of blood<br>glucose results. | Same fundamental scientific<br>technology<br>Equivalent radio-Frequency<br>protocol specifications | RF module contained in a<br>different blood glucose meter |

### Technological Characteristics

# Comparison with Predicate devices

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#### Performance Summary

| Performance<br>Characteristic | Test method employed | Results |
|-------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | ISO 15197:2003,<br>Section 7.2 | The OneTouch® UltraLink™ Blood Glucose<br>Monitoring System demonstrated acceptable<br>system precision. |
| Accuracy | ISO 15197:2003<br>Section 7.3 (7.4) | Ninety-five percent (95 %) of the individual<br>glucose results fell within ± 15 mg/dL of the<br>results of the reference method at glucose<br>concentrations < 75 mg/dL and within<br>± 20 % at glucose concentrations ≥75 mg/dL. |
| User Performance | ISO 15197:2003, Section 8 | Results from performance and human factors<br>studies at two U.S. clinical sites demonstrated<br>equivalent ability of lay and professional users to<br>obtain results suitable for the intended use of the<br>device. |
| Linearity | CLSI/NCCLS EP-6A | The OneTouch® UltraLink™ Blood Glucose<br>Monitoring System demonstrated acceptable<br>system linearity over the measurement range. |
| Safety and<br>Reliability | ISO 15197:2003, Section 6 | The OneTouch® UltraLink™ Blood Glucose<br>Monitoring System demonstrated acceptable<br>safety and reliability per the test methods<br>described. |

## Conclusion from Performance Evaluation

The OneTouch® UltraLink™ Blood Glucose Monitoring System demonstrates substantial equivalence to the OneTouch® Ultra®2 Blood Glucose Monitoring System, and to the BD Paradigm Link™ Blood Glucose Meter for the Radio-Frequency (wireless) communication feature.

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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 caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 1 8 2008

LifeScan, Inc. c/o Ms. Kim Fonda Regulatory Project Leader 1000 Gibraltar. Drive Milpitas, CA 95035

Re: k073231

Trade/Device Name: One Touch Ultralink Blood Glucose Monitoring System Regulation Number: 21 CFR§862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: April 01, 2008 Received: April 02, 2008

Dear Ms. Fonda:

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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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.

Sean 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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## Indication for Use

510(k) Number (if known): K073231

Device Name: OneTouch® UltraLink™ Blood Glucose Monitoring System

Indications For Use:

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

The OneTouch® UltraLink™ Blood Glucose monitor may be used to transmit glucose values to appropriate MiniMed Paradigm® and Guardian® REAL Time devices using radio frequency communication.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson
Division Sign Off

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K073231