ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM

K093745 · Lifescan, Inc. · NBW · Feb 11, 2011 · Clinical Chemistry

Device Facts

• Record ID: K093745
• Device Name: ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Lifescan, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. The OneTouch® Verio" Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio" Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv). The OneTouch® Verio™ Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

Device Story

System measures glucose in fresh capillary whole blood samples via electrochemical amperometric detection. Input: blood sample applied to test strip; electrical current generated by reaction between glucose and Glucose Dehydrogenase reagent; current transmitted to meter. Output: quantitative blood glucose concentration displayed to user. Used at home by patients with diabetes to monitor glycemic control. Healthcare providers may also use device for point-of-care testing. Output informs patient self-management decisions regarding diabetes therapy. System includes meter, test strips, and control solutions for verification of system performance.

Clinical Evidence

Bench testing included system accuracy, repeatability, and intermediate precision per ISO 15197:2003(E). User performance evaluation assessed accuracy and usability in intended users (patients and HCPs). System performance compared to YSI laboratory reference method. Results showed system accuracy and precision met requirements, performing similarly to the predicate device.

Technological Characteristics

Amperometric electrochemical detection; reagent uses Glucose Dehydrogenase. System includes meter, test strips, and control solutions. Connectivity/software details not specified beyond modified electronic/software design compared to predicate.

Indications for Use

Indicated for quantitative blood glucose measurement in people with diabetes. For single-patient, home-use, in vitro diagnostic testing of fresh capillary whole blood from fingertips, forearm, or palm. Not for neonatal use, diabetes diagnosis, or screening. Alternative site testing restricted to steady-state glucose conditions.

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)
• OneTouch® Select™ Control Solutions (K072543)

Submission Summary (Full Text)

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093745

#### 510(K) SUMMARY

| SPONSOR | LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035 U.S.A. | FEB 11 2011 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CORRESPONDENT | Lisa McGrath<br>LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, CA 95035<br>Phone: [phone]/e-mail: [e-mail] | |
| DEVICE NAME AND<br>CLASSIFICATION | Trade Name: OneTouch® Verio™ Blood Glucose Monitoring System<br>Common name: Glucose test system<br>Classification:<br>OneTouch® Verio™ Blood Glucose Meters and OneTouch® Verio™ Test Strips<br>are Class II devices (21 CFR § 862.1345, Product Code NBW, LFR)<br>OneTouch® Verio™ Control Solutions are Class I devices (21 CFR § 862.1660)<br>Product Code JJX | |

#### SYSTEM DESCRIPTION

The OneTouch® Verio" Blood Glucose Monitoring System consists of the OneTouch® Verio" Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio" Control Solutions (mid and high levels), the Lancing Device, Sterile Lancets and Clear Cap (sold separately). The OneTouch® Verio" System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.

## PREDICATE DEVICES

OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529) OneTouch® Select™ Control Solutions (K072543)

## INTENDED USE/INDICATIONS FOR USE

The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The OneTouch® Verio" Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio" Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use.

The OneTouch® Verio" Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

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#### 510(K) SUMMARY, CONTINUED

The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

#### COMPARISON TO PREDICATE DEVICES

The Subject device is different from the predicate device for the following aspects:

- Meter: ergonomic/physical design, user interface, hardware, modified electronic and software ● changes.
- Test Strip: materials of construction, physical layout of the strip electrodes, enzyme chemistry, . calibration coding and sample application location.
- Control Solution: glucose nominal levels, composition and color of control solutions. .

There have been no changes to the intended use, operating principle or scientific technology.

## TECHNOLOGICAL CHARACTERISTICS

There has been no change to the fundamental scientific technology, which is amperometric detection. The operating principle remains electrochemical reaction; however the Subject device uses Glucose Dehydrogenase and the predicate device uses Glucose Oxidase as the reagent.

#### SUMMARY OF PERFORMANCE CHARACTERISTICS

The OneTouch® Verio" 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 in the hands of intended users. The OneTouch® Verio" Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI).

#### System Accuracy

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

## System Accuracy Results for Glucose Concentrations <75 mg/dL

Percent (and number) of meter results that match the laboratory test

| Withi | Within | I<br>\$ \$1.64 |
|-----------------------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 78/06 /<br>/01 '<br>20%<br>I<br>I | 00/<br>the<br>I | ነው። የጥንተ፡ንጥር ጥናት (ኬሚስትሪ) የጥንተ፡ንጥር ጥናት (ኬሚስትሪ) የጥንተ፡ንጥር ጥናት (ኬሚስትሪ) የጥንተ፡ንጥር ጥናት (ኬሚስትሪ) የጥንተ፡ንጥር ጥናት (ኬሚስትሪ) የጥንተ፡ንጥር ጥናት (ኬሚስትሪ) የጥንተ፡ንጥር ጥናት (ኬሚስትሪ) የሚያስተዋል። የጥንተ<br>6106 |

## System Accuracy Results for Glucose Concentrations ≥75 mg/dL

Percent (and number) of meter results that match the laboratory test

| Within = J .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Within<br>+100<br> | Within ±15% | Within ±20% |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|------------------------|-------------|
| 318/504 | 1201<br>100 | 400/504 /<br>100<br>0% | ANICA |

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# 510(K) SUMMARY, CONTINUED

#### Regression Statistics

Samples were tested in duplicate on three test strip lots. Results indicate that the OneTouch® Verio" System compares well with a laboratory method.

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・

#### Precision

Within Run Precision (300 Venous Blood Tests)

| Target Glucose<br>(mg/dL) | Mean Glucose<br>(mg/dL) | Standard Deviation<br>(mg/dL) | Coefficient of<br>Variation (%) |
|---------------------------|-------------------------|-------------------------------|---------------------------------|
| 40 | 39.37 | 1.07 | 2.72 |
| 100 | 100.58 | 1.75 | 1.74 |
| 130 | 126.12 | 2.41 | 1.91 |
| 200 | 189.24 | 3.36 | 1.78 |
| 350 | 323.63 | 6.65 | 2.05 |

Results show that the greatest variability observed between test strips when tested with blood is 2.72% or less.

#### Total Precision

(600 Control Solution Tests)

| Glucose Level Ranges<br>(mg/dL) | Mean Glucose<br>(mg/dL) | Standard Deviation<br>(mg/dL) | Coefficient of<br>Variation (%) |
|---------------------------------|-------------------------|-------------------------------|---------------------------------|
| Low (38-62) | 50.66 | 1.28 | 2.53 |
| Mid (102-138) | 116.51 | 2.89 | 2.48 |
| High (298-403) | 350.02 | 7.7 | 2.2 |

#### User Performance Evaluation

Subject and HCP Fingertip Results for Glucose Concentrations <75 Mg/dL

| Tester | Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|---------|-----------------|------------------|------------------|
| Subject | 21/28<br>(75%) | 28/28<br>(100%) | 28/28<br>(100%) |
| | HCP | 16/28<br>(57.1%) | 24/28<br>(85.7%) |

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#### 510(K) SUMMARY, CONTINUED

| Tester | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---------|-------------------|--------------------|--------------------|--------------------|
| Subject | 68/128<br>(53.1%) | 115/128<br>(89.8%) | 127/128<br>(99.2%) | 128/128<br>(100%) |
| HCP | 74/125<br>(59.2%) | 109/125<br>(87.2%) | 120/125<br>(96.0%) | 124/125<br>(99.2%) |

Subject and HCP Fingertip Results for Glucose Concentrations ≥75 Mg/dL

## Alternate Site Testing

Subject AST Results for Glucose Concentrations <75 mg/dL

| Site | Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|---------|-----------------|------------------|------------------|
| Palm | 6/8<br>(75.0%) | 8/8<br>(100%) | 8/8<br>(100%) |
| Forearm | 4/7<br>(57.1%) | 6/7<br>(85.7%) | 7/7<br>(100%) |

#### Subject AST Results for Glucose Concentrations ≥75 mg/dL

| Site | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---------|-------------------|--------------------|--------------------|--------------------|
| Palm | 80/154<br>(51.9%) | 132/154<br>(85.7%) | 146/154<br>(94.8%) | 150/154<br>(97.4%) |
| Forearm | 66/144<br>(45.8%) | 110/144<br>(76.4%) | 127/144<br>(88.2%) | 138/144<br>(95.8%) |

Design verification and validation testing confirmed that the performance, safety, and effectiveness of the OneTouch® Verio" Blood Glucose Monitoring System were equivalent to that of the predicate device. The OneTouch® Verio Meter met recognized electrical and safety standards.

#### CONCLUSIONS

The OneTouch® Verio" Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety, effectiveness and the underlying scientific and operating principles used, to the predicate OneTouch® Ultra®2 Blood Glucose Monitoring System (K053529), and OneTouch® Select™ Control Solutions (K072543).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES '

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Image /page/4/Picture/3 description: The image shows the date February 1, 2011. The month is abbreviated as FEB. The day is 1 and the year is 2011. The text is in a bold, sans-serif font.

Life Scan, Inc. c/o Ms. Lisa McGrath Regulatory Project Manager/Global Regulatory Affairs 1000 Gibraltar Drive, MS 2C Milpitas, CA 95035-6312

Re: k093745

> Trade Name: One Touch Verio Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose Test System. Regulatory Class: Class II Product Codes: NBW, LFR, JJX Dated: February 8, 2011 Received: February 9, 2011

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 enclosuré) 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); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to paremarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 the [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

CJC.

Courtney Harper, 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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# INDICATIONS FOR USE FORM

510(k) Number (if known): _ K093745

OneTouch® Verio™ Blood Glucose Monitoring System Device Name: ____

Indications for Use:

The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The OneTouch® Verio" Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients.

The OneTouch® Verio" Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio™ Blood Glucose Monitoring System should not be used for the diagnosis of or screening of diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidlv).

The OneTouch® Verio™ Test Strips are for use with the OneTouch® Verio" Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The OneTouch® Verio" Control Solutions are for use with the OneTouch® Verio" Blood Glucose Meter and Test Strips to check that the meter and test strips are working together properly and that the test is performing correctly.

| Prescription Use<br>(Part 21 CFR 801<br>Subpart D) | AND/OR | Over-The-Counter Use <span style="text-decoration: underline;">X</span> (21 CFR 801<br>Subpart C) |
|----------------------------------------------------|--------|---------------------------------------------------------------------------------------------------|
|----------------------------------------------------|--------|---------------------------------------------------------------------------------------------------|

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

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

Carol C. Benson

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

510(k) K093745