OneTouch Verio Flex Blood Glucose Monitoring System

K150214 · Lifescan Europe · NBW · Jul 31, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150214
• Device Name: OneTouch Verio Flex Blood Glucose Monitoring System
• Applicant: Lifescan Europe
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OneTouch Verio Flex™ 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 fingertip. The OneTouch Verio Flex™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. OneTouch Verio Flex™ 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 Flex™ Blood Glucose Monitoring System is not to 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 Flex™ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

Device Story

System measures glucose in fresh capillary whole blood samples via test strips; utilizes amperometric electrochemical detection. Meter receives electrical current from test strip; processes signal to calculate glucose concentration. Features include ergonomic design, strip port connector, and range indicator software. Used by single patients at home for diabetes management. Output displayed on meter; assists patients in monitoring diabetes control effectiveness. System includes meter, test strips, control solutions, lancing device, and lancets.

Clinical Evidence

Clinical accuracy evaluated in 115 subjects (capillary blood) and a user performance study with 172 untrained lay users. Results compared to YSI 2300 reference method. In lay user study, 99.3% of results were within ±20% of reference for glucose ≥75 mg/dL and 95.2% within ±15 mg/dL for glucose <75 mg/dL. Bench testing included precision, linearity (20-600 mg/dL), interference, hematocrit (20-60%), altitude (up to 10,000 ft), and temperature/humidity studies.

Technological Characteristics

Amperometric glucose monitoring system; FAD-GDH enzyme chemistry. Meter uses multichip module, segmented monochrome LCD, and Bluetooth Smart connectivity. Powered by battery. Dimensions: 0.63 x 2.05 x 3.39 inches. Weight: 1.7 oz. Compliant with ISO 14971, ISO 10993-1, and EP07-A2/EP06-A guidelines. Sterilization: N/A (meter); test strips are dry reagent.

Indications for Use

Indicated for people with diabetes for self-testing of capillary whole blood glucose from the fingertip to monitor diabetes control. Contraindicated for neonatal use, diagnosis/screening of diabetes, critically ill patients, patients in shock, severely dehydrated patients, or hyperosmolar patients. Not indicated for alternate site testing.

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 (K131363)

Submission Summary (Full Text)

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

July 31, 2015

LIFESCAN EUROPE ALISON WILSON REGULATORY AFFAIRS PROJECT MANAGER BEECHWOOD PARK NORTH INVERNESS IV2 3ED, GREAT BRITAIN

Re: K150214

Trade/Device Name: One Touch Verio Flex™ Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: June 25, 2015 Received: July 02, 2015

Dear Alison Wilson:

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 Parts 801 and 809); 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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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours.

# Courtney

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

510(k) Number (if known) k150214

Device Name

OneTouch Verio FlexTM Blood Glucose Monitoring System

Indications for Use (Describe)

The OneTouch Verio Flex™ 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 fingertip. The OneTouch Verio Flex™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be be shared.

OneTouch Verio Flex™ 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 Flex™ Blood Glucose Monitoring System is not to 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 Flex™ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the LifeScan logo, which includes a blue globe on the left side and a blue swoosh above the text "LIFESCAN". Below the text, in a smaller, red font, it says "a Johnson & Johnson company". The logo is clean and professional, representing a well-established brand in the healthcare industry.

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

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

| Sponsor | LifeScan Europe, a Division of Cilag GmbH International<br>Gubelstrasse 34<br>Zug, Switzerland 6300 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Alison Wilson, Regulatory Affairs Project Manager<br>LifeScan Scotland Ltd.<br>Beechwood Park North<br>Inverness, IV2 3ED<br>United Kingdom<br>Phone: [phone]<br>e-mail: [e-mail]<br>Alternate 510(k) Contact:<br>Oyinkan Donaldson, Senior Regulatory Affairs Manager<br>LifeScan Scotland Ltd<br>Beechwood Park North<br>Inverness, IV2 3ED<br>United Kingdom<br>Phone: [phone]<br>Mobile: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | May 2015 |
| Device Trade Name | OneTouch Verio Flex Blood Glucose Monitoring System |
| Common Name | Glucose Test System |

LifeScan Europe, a Div. of Cilag GmbH International

Page 1 of 13

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/4/Picture/0 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in large, bold, blue letters. Below the company name is the text "a Johnson & Johnson company" in a smaller, red font. To the left of the company name is a blue globe and a curved blue line above the company name.

Division of Cilag GmbH International

#### Gubelstrasse 34 , CH-6300 Zug, Switzerland

| Classification | OneTouch Verio Flex™ Blood Glucose Meters and OneTouch Verio™<br>Test Strips are Class II devices (21 CFR § 862.1345), Product Code<br>NBW, LFR<br>OneTouch Verio™ Control Solutions are Class I devices (21 CFR<br>§862.1660), Product Code JJX<br>Lancing Device and Sterile Lancets are Class I (exempt) devices (21<br>CFR § 878.4800), Product Code FMK | |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| System Description | The OneTouch Verio Flex Blood Glucose Monitoring System consists<br>of the OneTouch Verio Flex Blood Glucose Meter, OneTouch® Verio®<br>Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions,<br>Lancing Device and Sterile Lancets. The OneTouch Verio Flex Blood<br>Glucose Monitoring System measures the glucose content of a blood<br>sample by means of an electrical current produced in the test strip and<br>sent to the meter for measurement. | |
| Predicate Device | OneTouch® Verio™ Blood Glucose Monitoring System (K131363,<br>Cleared 30th August 2013) | |
| Intended<br>Use/Indications for<br>Use | The OneTouch Verio Flex Blood Glucose Monitoring System is<br>intended to be used for the quantitative measurement of glucose (sugar)<br>in fresh capillary whole blood samples drawn from the fingertip. The<br>OneTouch Verio Flex Blood Glucose Monitoring System is intended to<br>be used by a single patient and should not be shared.<br>OneTouch Verio Flex Blood Glucose Monitoring System is intended for<br>self testing outside the body (in vitro diagnostic use) by people with<br>diabetes at home as an aid to monitor the effectiveness of diabetes<br>control. The OneTouch Verio Flex Blood Glucose Monitoring<br>System is not to 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<br>Verio Flex Blood Glucose Meter to quantitatively measure glucose<br>drawn from the fingertips. | | |
| Comparison to<br>Predicate Device | The Subject device is different from the predicate device in the<br>following aspects:<br>• Meter:<br>○ Ergonomic/physical design: Changes to size, shape and color<br>○ Electronic/hardware: Strip port connector<br>○ Software/Firmware changes: Modified Blood Glucose<br>Algorithm and addition of a range indicator software feature.<br>• Labelling:<br>○ New branding and Instructions for Use<br><br>There are no changes to the OneTouch® Verio® Test Strips or the<br>OneTouch® Verio® Level 3 (Mid) and Level 4 (High) Control Solutions<br>cleared for use with the predicate OneTouch® Verio™ Blood Glucose<br>Monitoring System 510(k) (K131363).<br><br>There have been no changes to the intended use, operating principle or<br>scientific technology. | |
| Technological<br>Characteristics | There has been no change to the fundamental scientific technology,<br>which is amperometric detection. The operating principle remains<br>electrochemical reaction. | |
| Summary of<br>Performance<br>Characteristics | The OneTouch Verio Flex Blood Glucose Monitoring System (meter,<br>strips, and control solutions) was designed and tested in accordance with<br>ISO 15197:2013(E). Analytical performance testing included system | |
| Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
| 77.8% | 100% | 100% |
| (42/54) | (54/54) | (54/54) |

LifeScan Europe, a Div. of Cilag GmbH International

Page 2 of 13

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/5/Picture/0 description: The image shows the LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the company name, in smaller red font, is the text "a Johnson & Johnson company".

Division of Cilag GmbH International

#### Gubelstrasse 34 , CH-6300 Zug, Switzerland

LifeScan Europe, a Div. of Cilag GmbH International

Page 3 of 13

Confidential and Proprietary Information

Part 2 510K Summary

Traditional 510(k)

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Image /page/6/Picture/0 description: The image shows the LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the company name, in smaller red cursive font, is the text "a Johnson & Johnson company".

Division of Cilag GmbH International

#### Gubelstrasse 34 , CH-6300 Zug, Switzerland

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 Flex Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI).

## Method Comparison Performance

A study evaluating the glucose values from the OneTouch Verio Flex Blood Glucose monitoring System (obtained by healthcare professional fingersick samples from diabetic subjects) and compared to the glucose results obtained by the recognized glucose reference method (YSL 2300) from 115 subjects showed the following results:

NOTE: first test sample data is presented here.

## Method Comparison Results for Glucose Concentrations <75 mg/dL

Percent (and number) of meter results that match the YSI reference

## Method Comparison Results for Glucose Concentrations ≥75 mg/dL

Percent (and number) of meter results that match the YSI reference

| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|------------|-------------|-------------|-------------|
| 62.9% | 94.8% | 98.6% | 99.3% |
| (183/291) | (276/291) | (287/291) | (289/291) |

LifeScan Europe, a Div. of Cilag GmbH International

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Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

# System Accuracy Results for Glucose concentrations across the glucose range:

Percent (and number) of meter results that match the YSI reference

| Within ±10 mg/dL (±0.83 mmol/L) or ±15% | Within ±10 mg/dL (±0.83 mmol/L) or ±20% |
|-----------------------------------------|-----------------------------------------|
| 98.8%<br>(341/345) | 99.4%<br>(343/345) |

LifeScan Europe, a Div. of Cilag GmbH International

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Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/8/Picture/0 description: The image contains the word "LifeScan" in a simple, sans-serif font. The text is black and appears against a white background. The word is presented in a straightforward, unadorned manner.

Image /page/8/Picture/1 description: The image shows the logo for LifeScan, a Johnson & Johnson company. The logo features the word "LIFESCAN" in large, bold, blue letters. Below the company name is the text "a Johnson & Johnson company" in a smaller, cursive font. To the left of the company name is a blue globe graphic.

A linear regression ananlysis of the method comparison study data demonstrated that the OneTouch®VerioFlex™ Blood Glucose Monitoring System (subject device) and the OneTouch® Verio" Blood Glucose Monitoring System (predicate device) are substantially equivalent; and that the subject device compared well to the laboratory reference instrument (YSI analyzer). NOTE: first test sample data is presented here and within the product labelling

| BGMS | Lot # | #<br>Participants | #<br>Tests | Slope<br>[95% CI] | Intercept<br>[95% CI]<br>(mg/dL) | Std.<br>Error<br>(Sy.x)<br>(mg/dL) | R2 |
|---------------------|-------|-------------------|------------|------------------------|----------------------------------|------------------------------------|-------|
| OneTouch® Verio™ | D | 115 | 115 | 0.97<br>[0.95 to 0.99] | 6.05<br>[2.41 to 9.69] | 10.15 | 0.99 |
| OneTouch®VerioFlex™ | A | 115 | 115 | 1.00<br>[0.98 to 1.02] | -0.31<br>[-4.04 to<br>3.42] | 10.41 | 0.99 |
| | B | 115 | 115 | 0.99<br>[0.97 to 1.01] | 1.14<br>[-2.91 to<br>5.20] | 11.33 | 0.99 |
| | C | 115 | 115 | 1.01<br>[0.99 to 1.03] | 0.01<br>[-4.13 to<br>4.16] | 11.57 | 0.99 |
| | | 3 lots | 345 | 345 | 1.00<br>[0.99 to 1.01] | 0.28<br>[-2.00 to<br>2.56] | 11.11 |

## Regression Statistics for the Subject and Predicate Device compared to YSI

Table above reflects regression limits of 15mg/dL <75mg/dl and % results within 15%>75mg/dL

LifeScan Europe, a Div. of Cilag GmbH International

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Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/9/Picture/0 description: The image shows the LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the word "LIFESCAN" is the phrase "a Johnson & Johnson company" in smaller, red letters. A blue swoosh appears above the globe and the word "LIFESCAN".

## Lay User Performance Evaluation

A study to validate the accuracy performance of the OneTouch Verio Flex Blood Glucose Monitoring System in the hands of the user was undertaken. A comparison of the Lay User OneTouch Verio Flex Blood Glucose Monitoring System fingertip results compared to glucose results obtained on the recognized glucose reference method (YSI 2300 STAT PLUS glucose analyzer), are summarized below. Glucose values from fingertip capillary blood samples obtained by 172 lay persons showed the following results:

## Subject Fingertip Results for Glucose Concentrations <75 mg/dL

Percent (and number) of meter results that match the YSI reference

| Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|-----------------|------------------|------------------|
| 76.2% | 95.2% | 95.2% |
| (16/21) | (20/21) | (20/21) |

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

Percent (and number) of meter results that match the YSI reference

| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|------------|-------------|-------------|-------------|
| 58.3% | 88.7% | 98.0% | 99.3% |
| (88/151) | (134/151) | (148/151) | (150/151) |

## Precision (Repeatability)

Within Run Precision (300 Venous Blood Samples Tested per glucose level)

| LifeScan Europe, a Div. of Cilag GmbH International | Page 7 of 13 |
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| Part 2 510K Summary | <b>Confidential and Proprietary Information</b> |
| Traditional 510(k) | OneTouch Verio FlexTM Blood Glucose Monitoring System |

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Image /page/10/Picture/0 description: The image shows the LifeScan logo, which features the company name in bold, blue letters. Above the name is a blue swoosh, and to the left is a blue globe. Below the company name, in smaller, red cursive letters, is the text "a Johnson & Johnson company."

Division of Cilag GmbH International

#### Gubelstrasse 34 , CH-6300 Zug, Switzerland

| Target Glucose | Mean Glucose | Standard Deviation | Coefficient of |
|----------------|--------------|--------------------|----------------|
| (mg/dL) | (mg/dL) | (mg/dL) | Variation (%) |
| 20 | 18.3 | 0.63 | 3.43 |
| 40 | 36.5 | 0.83 | 2.26 |
| 90 | 88.5 | 1.72 | 1.95 |
| 130 | 127.9 | 2.50 | 1.95 |
| 200 | 199.3 | 3.94 | 1.98 |
| 350 | 344.6 | 6.18 | 1.79 |
| 600 | 583.4 | 10.54 | 1.81 |

Results show that the greatest variability observed between test strips when tested with blood is 1.72mg/dl SD or less at glucose levels less than 100mg/dl, or 1.98% or less at glucose levels at 100mg/dl or above

## Total Precision (Intermediate 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 (%) |
|------------------------------------|-------------------------|-------------------------------|---------------------------------|
| Very Low (0-24) | 12.46 | 0.57 | 4.54 |
| Low (25 - 49) | 37.14 | 0.92 | 2.48 |
| Mid (102 - 138) | 117.68 | 2.41 | 2.05 |
| High (298 – 403) | 348.99 | 8.31 | 2.38 |
| Very High (446-604) | 515.18 | 13.53 | 2.63 |

LifeScan Europe, a Div. of Cilag GmbH International

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Image /page/11/Picture/0 description: The image shows the logo for LifeScan, a Johnson & Johnson company. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the company name is the text "a Johnson & Johnson company" in a smaller, handwritten-style font.

#### System Accuracy performance in accordance with ISO 15197:2013(E)

Accuracy of the subject device was analysed and assessed in compliance with the product design requirements in accordance with the requirements of ISO 15197:2013(E) Clause 6.3 System Accuracy and Clause 8 User Performance Evaluation.

#### System Accuracy in compliance with ISO 15197:2013(E) Clause 6.3:

A study was conducted to evaluate glucose values from fingertip capillary blood samples obtained by healthcare professionals from 100 subjects in accordance with the glucose ranges required by ISO15197:2013 Clause 6.3.5. The analysis showed the following results: 100% for all 3 test strip lots within ±15mg/dl of the medical laboratory values at glucose concentrations below 100mg/dL and 99.3%, 100%, 98.7% within ±15% of the medical laboratory values at glucose concentrations at or above 100mg/dL.

## System Accuracy Results for Glucose Concentrations <100 mg/dL

Percent (and number) of meter results that match the YSI reference

| Test Strip Lot Number | Within ±5mg/dL | Within ±10mg/dL | Within ±15mg/dL |
|-----------------------------|--------------------|--------------------|-------------------|
| A | 86%<br>(43/50) | 98%<br>(49/50) | 100%<br>(50/50) |
| B | 80%<br>(40/50) | 98%<br>(49/50) | 100%<br>(50/50) |
| C | 80%<br>(40/50) | 98%<br>(49/50) | 100%<br>(50/50) |
| Pooled Results for Lots A-C | 82.0%<br>(123/150) | 98.0%<br>(147/150) | 100%<br>(150/150) |

## System Accuracy Results for Glucose Concentrations ≥100 mg/dL

Percent (and number) of meter results that match the YSI reference

LifeScan Europe, a Div. of Cilag GmbH International Page 9 of 13 Confidential and Proprietary Information

Part 2 510K Summary

Traditional 510(k)

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Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

| Test Strip Lot Number | Within ±5% | Within ±10% | Within ±15% |
|--------------------------------|--------------------|--------------------|--------------------|
| A | 65.3%<br>(98/150) | 93.3%<br>(140/150) | 99.3%<br>(149/150) |
| B | 64.0%<br>(96/150) | 96.0%<br>(144/150) | 100%<br>(150/150) |
| C | 59.3%<br>(89/150) | 94.7%<br>(142/150) | 98.7%<br>(148/150) |
| Pooled Results for Lots<br>A-C | 62.9%<br>(283/450) | 94.7%<br>(426/450) | 99.3%<br>(447/450) |

## System accuracy results across the glucose range tested: concentrations between 38.2 mg/dL and 466.3 mg/dL

Percent (and number) of meter results that match the YSI reference

| Test Strip Lot Number | Within ±15mg/dL or ±15% |
|------------------------|-------------------------|
| A | 99.5%<br>(199/200) |
| B | 100%<br>(200/200) |
| C | 99.0%<br>(198/200) |
| Pooled Results for A-C | 99.5%<br>(597/600) |

NOTE: Where 38.2 mg/dL represents the lowest glucose reference value and 466.3 mg/dL represents the highest glucose reference value (YSI value).

## User Performance Evaluation in compliance with ISO 15197:2013(E) Clause 8

| LifeScan Europe, a Div. of Cilag GmbH International | Page 10 of 13 |
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| Part 2 510K Summary | <i>Confidential and Proprietary Information</i> |
| Traditional 510(k) | OneTouch Verio Flex™ Blood Glucose Monitoring System |

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Image /page/13/Picture/0 description: The image shows the LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in large, bold, blue letters. Below the word "LIFESCAN" is the text "a Johnson & Johnson company" in a smaller, red, cursive font. A blue swoosh design arches over the globe and the word "LIFESCAN".

Division of Cilag GmbH International Gubelstrasse 34 , CH-6300 Zug, Switzerland

A study to validate the accuracy performance of the OneTouch Verio Flex Blood Glucose Monitoring System in the hands of the Lay user in accordance with ISO 15197:2013(E) Clause 8 was undertaken. A comparison of the Lay User OneTouch Verio Flex Blood Glucose Monitoring System fingertip results compared to glucose results obtained on the recognized glucose reference method (YSI 2300 STAT PLUS glucose analyzer), are summarized below:

Glucose values from fingertip capillary blood samples obtained by 167 lay persons showed the following results:

93.1% within ±15mg/dl of the glucose reference (YSI) values at glucose concentrations below 100mg/dL and 98.6% within ±15% of the medical laboratory values at glucose concentrations at or above 100mg/dL.

97.6% of the total number of samples across the entire glucose range were within ±15 mg/dl or ±15% of the medical laboratory values.

# Subject Fingertip Results for Glucose Concentrations <100 mg/dL

Percent (and number) of meter results that match the YSI reference

| Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|-----------------|------------------|------------------|
| 72.4% | 93.1% | 93.1% |
| (21/29) | (27/29) | (27/29) |

# Subject Fingertip Results for Glucose Concentrations ≥100 mg/dL

Percent (and number) of meter results that match the YSI reference

| Within ±5% | Within ±10% | Within ±15% |
|-------------------|--------------------|--------------------|
| 58.7%<br>(81/138) | 88.4%<br>(122/138) | 98.6%<br>(136/138) |

## Results for Glucose concentrations across the glucose range:

LifeScan Europe, a Div. of Cilag GmbH International

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Part 2 510K Summary

Traditional 510(k)

OneTouchVerio Flex™ Blood Glucose Monitoring System

Confidential and Proprietary Information

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the LifeScan logo, which features a blue globe on the left side and the word "LIFESCAN" in large, bold, blue letters. Above the word LIFESCAN is a blue curved line. Below the word LIFESCAN is the text "a Johnson & Johnson company" in a smaller, cursive font.

Division of Cilag GmbH International

#### Gubelstrasse 34 , CH-6300 Zug, Switzerland

#### Percent (and number) of meter results that match the YSI reference

# Within ±15 mg/dL (±0.83 mmol/L) or ±15%

97.6% (163/167)

LifeScan Europe, a Div. of Cilag GmbH International

Page 12 of 13

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/15/Picture/0 description: The image shows the logo for LifeScan, a Johnson & Johnson company. The logo features the company name in a bold, blue font, with a blue swoosh above it. To the left of the company name is a blue globe. Below the company name, in a smaller, red font, is the text "a Johnson & Johnson company."

Division of Cilag GmbH International Gubelstrasse 34 , CH-6300 Zug, Switzerland

#### Summary

Design verification and validation testing confirmed that the performance, safety, and effectiveness of the OneTouch® VerioFlex™ Blood Glucose Monitoring System were met against all design input specifications and the system can be considered substantially equivalent to that of the predicate device. The OneTouch Verio Flex Meter also meets the requirements of ISO15197:2013 and applicable recognized electrical and safety standards including FCC requirements.

#### Conclusions

The OneTouch® Verio Flex™ Blood Glucose Monitoring System is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principles to the predicate, the OneTouch® Verio" Blood Glucose Monitoring System (K131363).

LifeScan Europe, a Div. of Cilag GmbH International

Page 13 of 13

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)