ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM

K120708 · Cilag GmbH International · NBW · Feb 7, 2013 · Clinical Chemistry

Device Facts

• Record ID: K120708
• Device Name: ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Cilag GmbH International
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single person and should not be shared. The OneTouch Verio Sync BGMS 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 Sync BGMS 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 Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

Device Story

System measures glucose in fresh capillary whole blood via amperometric electrochemical reaction in test strips. Input: blood sample on test strip; output: glucose concentration displayed on meter. Device includes meter, test strips, control solutions, lancing device, and lancets. Used at home by patients with diabetes. Features wireless communication with OneTouch Reveal Diabetes Management Application and rechargeable battery. Output allows patients to monitor diabetes control effectiveness. Differences from predicate include ergonomic design, simplified UI, wireless connectivity, and rechargeable battery; no changes to core electrochemical sensing technology.

Clinical Evidence

System accuracy evaluated via method comparison against YSI 2300 reference using 100 participants (glucose range 40-434 mg/dL). User performance study conducted with 273 untrained lay users (glucose range 49-506 mg/dL). Results showed 100% of samples within ±20% of reference for concentrations ≥75 mg/dL and 100% within ±15 mg/dL for concentrations <75 mg/dL. Precision studies (repeatability and intermediate) demonstrated CVs between 1.49% and 3.04%. Bench testing confirmed performance across hematocrit (20-60%), altitude (up to 10,000 ft), and temperature/humidity ranges.

Technological Characteristics

Amperometric measurement using GDH-FAD enzyme dry reagent assay. Plasma-calibrated. Dimensions: 3.9 x 1.6 x 0.5 inches. Connectivity: Bluetooth wireless to mobile devices. Power: AC adaptor/USB. Operating range: 50–111°F, 10–90% humidity. Hematocrit range: 20–60%. Standards: CLSI EP06-A, EP07-A, ISO 15197:2003, IEC 61010-1, IEC 61326-1.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertips in people with diabetes for home monitoring of diabetes control. Not for neonatal use, diabetes diagnosis/screening, or use on critically ill, shock, dehydrated, hypotensive, or hyper-osmolar patients.

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 Verio Blood Glucose Monitoring System (k093745)

Reference Devices

• OneTouch Verio IQ (K110637)

Submission Summary (Full Text)

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K120708

# (510(k) Summary (as required by section 807.92(c).

FEB 7 2013

| Sponsor | LifeScan Europe, a Division of Cilag GmbH<br>International<br>Landis and Gyr Strasse 1<br>Zug, Switzerland 6300 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Nadine Nasr, Regulatory Project Manager<br>LifeScan, Inc.<br>1000 Gibraltar Drive<br>Milpitas, California 95035<br>Phone: [phone]<br>Email: [e-mail]<br>Alternate 510(k) Contact:<br>Yvonne Middlefell, Director Regulatory Affairs<br>LifeScan Scotland Ltd<br>Beechwood Business Park North<br>Inverness, Scotland IV2 3ED<br>United Kingdom<br>Phone: [phone]<br>Mobile: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared | 07th Feb 2013 |
| Device Trade Name | OneTouch Verio Sync Blood Glucose Monitoring<br>System |
| Common Name | Glucose Test System |

LifeScan Europe, a Div. of Cilag GmbH International

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| Classification | OneTouch Verio Sync Blood Glucose Meters and<br>OneTouch Verio Test Strips are Class II devices (21<br>CFR § 862.1345), Product Code NBW, LFR | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| System Description | The OneTouch® Verio™ Sync Blood Glucose<br>Monitoring System consists of the OneTouch® Verio™<br>Sync Blood Glucose Meter, OneTouch® Verio™ Test<br>Strips, OneTouch® Verio™ Level 3 and Level 4<br>Control Solutions, Lancing Device and Sterile<br>Lancets. The OneTouch® Verio™ Sync Blood Glucose<br>Monitoring System measures the glucose content of a<br>blood sample by means of an electrical current<br>produced in the test strip and sent to the meter for<br>measurement. | |
| Predicate Device | OneTouch Verio Blood Glucose Monitoring System<br>(K093745, cleared on February 11, 2011) | |
| Intended Use/Indications for Use | The OneTouch Verio Sync Blood Glucose<br>Monitoring System (BGMS) is intended to be used<br>for the quantitative measurement of glucose (sugar) in<br>fresh capillary whole blood samples drawn from the<br>fingertip. The system is intended to be used by a<br>single person and should not be shared.<br><br>The OneTouch Verio Sync BGMS is intended for self<br>testing outside the body (in vitro diagnostic use) by<br>people with diabetes at home as an aid to monitor the<br>effectiveness of diabetes control. The OneTouch<br>Verio Sync BGMS should not be used for the<br>diagnosis of or screening of diabetes or for neonatal<br>use.<br><br>The OneTouch Verio Test Strips are for use with the<br>OneTouch Verio Sync Blood Glucose Meter to<br>quantitatively measure glucose (sugar) in fresh | |
| | capillary whole blood samples drawn from the fingertips. | |
| Comparison to Predicate Device | The Subject device is different from the predicate device for the following aspects:<br>• Meter: shape/size, ergonomic design,<br>simplified user interface, wireless communication with the OneTouch Reveal Diabetes Management Application and a rechargeable battery.<br><br>There have been no changes to the OneTouch® Verio™ Test Strip principle of operation, materials of construction, design of strip or electrodes, and they are identical to the test strips in the OneTouch® Verio™ Blood Glucose Monitoring System, K093745. The OneTouch® Verio™ Control Solutions composition and functional performance are also the same as those cleared in the OneTouch® Verio™ Blood Glucose Monitoring System, K093745. However, changes were made to the labeling provided with those components of the system at the request of the Food and Drug Administration during review of the OneTouch Verio IQ 510(k) Submission, K110637. There are some differences in the intended use, specifically around alternate site testing and the removal of the indication for forearm or palm testing. The OneTouch Verio Sync Blood Glucose Monitoring System is not validated for alternate site testing. Only | |
| | fingertip testing is indicated for this system. | |
| Technological Characteristics | There has been no change to the fundamental scientific | |
| | technology, which is amperometric detection. The | |
| | operating principle remains electrochemical reaction. | |
| | | |
| Summary of Performance | The OneTouch® Verio™ Sync Blood Glucose | |
| Characteristics | Monitoring System (meter, strips, and control | |
| | solutions) was tested in accordance with ISO | |
| | 15197:2003(E). Analytical performance testing | |
| | included system accuracy, repeatability, intermediate | |
| | precision and linearity testing. A user performance | |
| | evaluation assessed accuracy of results and usability of | |
| | the device in the hands of intended users. The | |
| | OneTouch® Verio™ Sync Blood Glucose Monitoring | |
| | System performed similarly to both the predicate | |
| | device as well as to a laboratory reference method, the | |
| | Yellow Springs Instrument (YSI). | |

LifeScan Europe, a Div. of Cilag GmbH International

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LifeScan Europe, a Div. of Cilag GmbH International

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LifeScan Europe, a Div. of Cilag GmbH International

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#### System Accuracy

A comparison of system accuracy performance demonstrated that the OneTouch® Verio" Sync Blood Glucose Monitoring System and the OneTouch® Verio™ Blood Glucose Monitoring System are substantially equivalent.

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

Number (and percent) of meter results that match the laboratory test

| Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|-----------------|------------------|------------------|
| 40/57 (70%) | 55/57 (96%) | 57/57 (100%) |

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

Number (and percent) of meter results that match the laboratory test

| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---------------|---------------|------------------|----------------|
| 174/243 (72%) | 235/243 (97%) | 242/243 (99.59%) | 243/243 (100%) |

LifeScan Europe, a Div. of Cilag GmbH International

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### Total Precision

(600 Control Solution Tests)

| Glucose Level<br>Ranges<br>(mg/dL) | Mean Glucose<br>(mg/dL) | Standard Deviation<br>(mg/dL) | Coefficient of<br>Variation (%) |
|------------------------------------|-------------------------|-------------------------------|---------------------------------|
| Low (38-62) | 38.63 | 0.88 | 2.27 |
| Mid (102-138) | 117.39 | 2.00 | 1.70 |
| High (298-403) | 335.91 | 6.25 | 1.86 |

#### User Performance Evaluation

Subject Fingertip Results for Glucose Concentrations <75 mg/dL

| Tester | Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|---------|-----------------|------------------|------------------|
| Subject | 5/23 (22%) | 15/23 (65%) | 22/23 (96%) |

Subject Fingertip Results for Glucose Concentrations ≥75 mg/dL

| Tester | Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|---------|---------------|---------------|---------------|---------------|
| Subject | 141/250 (56%) | 219/250 (88%) | 242/250 (97%) | 248/250 (99%) |

LifeScan Europe, a Div. of Cilag GmbH International

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

### Conclusions

The OneTouch Verio Sync Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principles used to the predicate, the OneTouch Verio Blood Glucose Monitoring System (K093745, 2/11/11).

LifeScan Europe, a Div. of Cilag GmbH International

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Image /page/7/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular pattern around a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines beneath them, possibly representing water or movement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### February 7, 2013

Cilag GMBH International c/o Nadine Nasr, Regulatory Project Manager Lifescan, Inc. 1000 Gibraltar Drive Milpitas, CA 95035

Re: k120708

Trade/Device Name: OneTouch Verio Sync Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: January 09, 2013

Received: January 30, 2013

#### Dear Ms. Nasr:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2—Ms. Nasr

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you usille speeffice aov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson for

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

510(k) Number (if known): k120708

Device Name: OneTouch Verio Sync Blood Glucose Monitoring System

Indications for Use:

The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single person and should not be shared.

The OneTouch Verio Sync BGMS 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 Sync BGMS 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 Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.

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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Devices and Radiologic Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Devices and Radiologic Health

510(k)_k120708

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