OneTouch Ultra Plus Flex Blood Glucose Monitoring System

K151611 · Lifescan Europe · NBW · Dec 14, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151611
• Device Name: OneTouch Ultra Plus Flex Blood Glucose Monitoring System
• Applicant: Lifescan Europe
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 14, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OneTouch Ultra Plus 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 Ultra Plus Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. OneTouch Ultra Plus 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 Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. The OneTouch Ultra Plus Test Strips are for use with the OneTouch Ultra Plus 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 reaction. User applies blood to strip; meter processes electrical current to calculate glucose concentration. Designed for single-patient home use; operated by patient. Includes meter, test strips, control solutions, lancing device, and sterile lancets. Features wireless communication and range indicator software. Output displayed on meter screen; assists patients in monitoring diabetes control effectiveness. Benefits include convenient, accurate self-monitoring of blood glucose levels.

Clinical Evidence

Clinical performance evaluated via user performance study with 169 lay users. Results compared to YSI reference method. For glucose < 75 mg/dL, 95% of results were within ±15 mg/dL. For glucose > 75 mg/dL, 100% of results were within ±20%. Linear regression showed slope 1.02, R² 0.99. Usability study confirmed labeling comprehension.

Technological Characteristics

Amperometric glucose monitoring system. Reagent: FAD-GDH, potassium ferricyanide. Power: 3V Li battery (CR2032). Connectivity: Bluetooth Low Energy, USB. Operating range: 10-40°C, 10-90% RH. Software: Gemini Blood Glucose algorithm. Sterilization: N/A (non-sterile device).

Indications for Use

Indicated for single-patient, home-use, in vitro diagnostic quantitative measurement of glucose in fresh capillary whole blood from the fingertip by people with diabetes to monitor diabetes control. Not for diagnosis, screening, or neonatal use.

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

December 14, 2015

LIFESCAN EUROPE NIKI SKELLY REGULATORY AFFAIRS CONSULTANT BEECHWOOD PARK NORTH INVERNESS, SCOTLAND IV2 3ED, GREAT BRITAIN

Re: K151611

Trade/Device Name: OneTouch Ultra Plus Flex Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW. LFR Dated: November 17, 2015 Received: November 20, 2015

Dear Niki Skelly:

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,

# Katherine Serrano -S

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

510(k) Number (if known) K151611

Device Name

OneTouch Ultra Plus Flex Blood Glucose Monitoring System

Indications for Use (Describe)

The OneTouch Ultra Plus 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 One Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be be shared.

OneTouch Ultra Plus 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 One Duch Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use.

The OneTouch Ultra Plus Test Strips are for use with the OneTouch Ultra Plus 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. The logo features a blue arc over the word "LIFESCAN" in blue, block letters. Below the company name is the phrase "a Johnson & Johnson company" in a cursive, red font. To the left of the company name is a blue globe.

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 | Niki Skelly, Regulatory Affairs Consultant<br>LifeScan Scotland Ltd.<br>Beechwood Park North<br>Inverness, IV2 3ED<br>United Kingdom<br>Phone: [phone]<br>Mobile : [phone]<br>e-mail: [e-mail]<br>Alternate 510(k) Contact:<br>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>Mobile: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] |
| Date Prepared | December 11th 2015 |
| Device Trade Name | OneTouch Ultra Plus Flex Blood Glucose Monitoring System |
| Common Name | Glucose Test System |
| Classification | OneTouch Ultra Plus Flex Blood Glucose Meters and OneTouch Ultra<br>Plus Test Strips are Class II devices (21 CFR § 862.1345), Product<br>Code NBW, LFR |
| System Description | The OneTouch Ultra Plus Flex Blood Glucose Monitoring System<br>consists of the OneTouch Ultra Plus Flex Blood Glucose Meter,<br>OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Level 3 and<br>Level 4 Control Solutions, Lancing Device and Sterile Lancets. The |
| | OneTouch Ultra Plus Flex Blood Glucose Monitoring 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 Device | OneTouch® Verio™ Blood Glucose Monitoring System (K131363,<br>Cleared 30th August 2013) |
| Intended<br>Use/Indications for<br>Use | The OneTouch Ultra Plus 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 Ultra Plus Flex Blood Glucose Monitoring System is<br>intended to be used by a single patient and should not be shared.<br>The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is<br>intended for self testing outside the body (in vitro diagnostic use) bydiabetes control. The OneTouch Ultra Plus Flex Blood Glucose<br>Monitoring System is not to be used for the diagnosis of or screening of<br>diabetes, or for neonatal use.<br>The OneTouch Ultra Plus Test Strips are for use with the OneTouch<br>Ultra Plus 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: |
| | Meter:<br>• Ergonomic/physical design: Changes to size, shape and color<br>• Electronic/hardware: Modified Strip Port Connector and<br>addition of wireless communications facility<br>• Software/Firmware changes: Modified Blood Glucose<br>Algorithm and addition of a range indicator software feature<br>• Labelling: |
| | New branding and Instructions for Use for Meter, Test Strips<br>and Control Solutions |
| | Strip: |
| | Change to color of spacer layer |
| | Laser line on left strip leg to align with new Strip Port<br>Connector |
| | The only change to the Control Solutions cleared for use with the<br>predicate OneTouch® Verio™ Blood Glucose Monitoring System 510(k)<br>(K131363) as OneTouch Verio Control Solutions Level 3 (Mid) and<br>Level 4 (High) is that a new brand name of OneTouch Ultra Plus Level<br>3 (Mid) and Level 4 (High) Control Solutions will be used to align<br>branding with the new system; the formula is identical to the cleared<br>Control Solution. The OneTouch Verio Control Solutions will continue<br>to be marketed with the associated cleared BGMS. |
| | 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 Ultra Plus Flex Blood Glucose Monitoring System<br>(meter, strips, and control solutions) was designed and tested in<br>accordance with ISO 15197:2013(E). Analytical performance testing<br>included interference, system accuracy, repeatability, intermediate<br>precision and linearity testing. A user performance evaluation assessed<br>accuracy of results and usability of the device in the hands of intended<br>users. The OneTouch Ultra Plus Flex Blood Glucose Monitoring<br>System performed similarly to both the predicate device and a<br>laboratory reference method, the Yellow Springs Instrument (YSI). |

LifeScan Europe, a Div. of Cilag GmbH International

Page 1 of 15

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 logo for LifeScan, a Johnson & Johnson company. The logo features a blue globe on the left, followed by the company name "LIFESCAN" in large, bold, blue letters. Below the company name, in smaller red cursive font, is the text "a Johnson & Johnson company". The logo has a curved line above the globe and company name.

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

LifeScan Europe, a Div. of Cilag GmbH International

Page 2 of 15

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 logo for LifeScan, a Johnson & Johnson company. The logo features the word "LIFESCAN" in large, bold, blue letters. Above the word is a blue swoosh and a blue globe. Below the word is the text "a Johnson & Johnson company" in a smaller, red font.

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

LifeScan Europe, a Div. of Cilag GmbH International

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image is the logo for LifeScan, a Johnson & Johnson company. The logo features a blue swoosh design above a globe graphic on the left. The text "LIFESCAN" is written in large, bold, blue letters, and below it, in a smaller, cursive, red font, is the text "a Johnson & Johnson company".

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

# Interference Performance

The maximum allowed concentration of every potentially interfering substance was tested in a study (i.e. the highest concentration tested that would not compromise system response of the OneTouch Ultra Plus Flex System). Samples with 2 levels of glucose 70 and 300mg/dL were tested by spiking with potentially interfering substances at 4 concentrations, each sample was analyzed by the OneTouch Ultra Plus Flex meter. Test results of the spiked samples were compared with results from control samples without potential interfering substances and the difference between the 2 samples was calculated. The results in the table below are within ≤10% of the control sample.

| Interferent | Maximum<br>Allowed<br>Concentration<br>(mg/dL) | Does the Maximum Allowed<br>Concentration exceed the High<br>Normal/Therapeutic<br>Endogenous Concentration? |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acetaminophen | 10.892 | Yes |
| Ascorbic Acid | 6.38 | Yes |
| Bilirubin | 20.53 | Yes |
| Cholesterol | 794.4 | Yes |
| Creatinine | 31.83 | Yes |
| Dopamine | 0.0512 | Yes |
| EDTA | 0.10 | Yes |
| Ephedrine | 0.21 | Yes |
| Galactose | 60.39 | Yes |
| Gentisic Acid | 1.85 | Yes |
| Glutathione | 92.61 | Yes |
| Haemoglobin | 237.6 | Yes |
| Heparin | 2.15 | Yes |
| Ibuprofen | 50.52 | Yes |
| Icodextrin | 1241.72 | Yes |
| Interferent | Maximum<br>Allowed<br>Concentration<br>(mg/dL) | Does the Maximum Allowed<br>Concentration exceed the High<br>Normal/Therapeutic<br>Endogenous Concentration? |
| Lactose | 4.25 | Yes |
| L-Dopa (Levo-Dopa) | 1.01 | Yes |
| Maltose | 363.60 | Yes |
| M-Dopa (Methyl-Dopa) | 1.50 | Yes |
| Pralidoxime Iodide (PAM) | OneTouch Ultra<br>Plus Flex Blood<br>Glucose<br>Monitoring<br>system not to be<br>used with<br>patients<br>undergoing<br>PAM treatment | No<br>OneTouch Ultra Plus Flex<br>SMBG system is not to be used<br>with patients undergoing PAM<br>treatment: Caution included in<br>product labelling4 |
| Salicylic Acid | 58.90 | Yes |
| Tetracycline | 1.52 | Yes |
| Tolazamide | 15.03 | Yes |
| Tolbutamide | 65.98 | Yes |
| Triglycerides | 3431.11 | Yes |
| Urea | 297.55 | Yes |
| Uric Acid | 8.11 | Yes |
| Interferent | Maximum<br>Allowed<br>Concentration<br>(mg/dL) | Does the Maximum Allowed<br>Concentration exceed the High<br>Normal/Therapeutic<br>Endogenous Concentration? |
| Xylose | 8.09 | No<br>OneTouch Ultra Plus Flex<br>SMBG system is not to be used<br>with patients undergoing xylose<br>absorption treatment:<br>Caution included in product<br>labelling 3 |

LifeScan Europe, a Div. of Cilag GmbH International

Page 4 of 15

Part 2 510K Summary

# Confidential and Proprietary Information

Traditional 510(k)

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Image /page/7/Picture/0 description: The image shows the LifeScan logo, which includes a blue globe on the left side. To the right of the globe is the company name, "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

LifeScan Europe, a Div. of Cilag GmbH International

Page 5 of 15

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/8/Picture/0 description: The image shows the LifeScan logo, which is a blue, stylized wordmark. The word "LIFESCAN" is written in large, bold, blue letters. Below the wordmark, in smaller red letters, is the phrase "a Johnson & Johnson company". To the left of the wordmark is a blue globe with a blue swoosh above the wordmark.

LifeScan

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

Based on the results in this table, interferent limitations identified in labeling are noted below 1 2 3 4 ップ クリッ

1 Uric acid at concentrations greater than 8mg/dL can interfere with glucose measurements.

2 Drugs containing acetaminophen (e.g Tylenol etc.) or Dopamine at doses higher than the recommended high therapeutic level, may result in inaccurate readings from the OneTouch Ultra Plus Flex™ blood glucose monitoring system.

3 The OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System should not be used within 24 hours of receiving a D-xylose absorption test as it may cause inaccurately high results.

4 The OneTouch Ultra Plus Flex™ Meter should not be used when PAM (Pralidoxime) is known or suspected to be in the whole blood sample.

LifeScan Europe, a Div. of Cilag GmbH International

Page 6 of 15

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, which features the company name in bold, blue letters. Above the name is a blue swoosh and a globe graphic. Below the name, in smaller red font, is the text "a Johnson & Johnson company."

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

# Method Comparison Performance

A study evaluating the glucose values from the OneTouch Ultra Plus 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 (YSI 2300) from 113 subjects showed the following results: NOTE: first test sample data is presented here.

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

| Within ±5 mg/dL | Within ±10 mg/dL | Within ±15 mg/dL |
|------------------|------------------|------------------|
| 71.7%<br>(43/60) | 95.0%<br>(57/60) | 100%<br>(60/60) |

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% |
|--------------------|--------------------|--------------------|-------------------|
| 61.3%<br>(171/279) | 89.6%<br>(250/279) | 98.6%<br>(275/279) | 100%<br>(279/279) |

#### 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% |
|-----------------------------------------|
| 97.9%<br>(332/339) |

A linear regression ananlysis of the method comparison study indicates that the OneTouch Ultra Plus Flex Blood Glucose Monitoring System compared well to the laboratory reference instrument (YSI analyzer). Comparison of the OneTouch Ultra Plus Flex Blood Glucose Monitoring System (subject device) and OneTouch Verio Blood Glucose Monitoring System (predicate device), based on the difference between the proportions of results within +10mg/dl or + 15% of the corresponding reference values,indicates that the subject device and the predicate device are substantially equivalent.

LifeScan Europe, a Div. of Cilag GmbH International

#### Page 7 of 15

Part 2 510K Summary

# Confidential and Proprietary Information

Traditional 510(k)

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Image /page/10/Picture/0 description: The image shows the LifeScan logo, which includes a blue swoosh design above the text. The text "LIFESCAN" is written in a bold, blue font. Below the main text, there is a smaller tagline that reads "a Johnson & Johnson company" in a cursive, red font. The logo also features a globe graphic on the left side.

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

NOTE: first test sample data is presented here and within the product labelling

| BGMS | Lot # | # 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<br>Verio | D | 113 | 0.98<br>[0.96 to 1.00] | 4.86<br>[1.10 to 8.61] | 10.6 | 0.99 |
| OneTouch<br>Ultra Plus<br>Flex | A | 113 | 1.02<br>[1.00 to 1.05] | -2.16<br>[-6.66 to 2.33] | 12.7 | 0.99 |
| | B | 113 | 0.99<br>[0.97 to 1.01] | -1.54<br>[-5.37 to 2.30] | 10.8 | 0.99 |
| | C | 113 | 1.01<br>[0.99 to 1.02] | -2.33<br>[-5.94 to 1.27] | 10.2 | 0.99 |
| | 3 lots | 339 | 1.01<br>[1.00 to 1.02] | -2.01<br>[-4.35 to 0.33] | 11.5 | 0.99 |

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

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

# Lay User Performance Evaluation

A study to validate the accuracy performance of the OneTouch Ultra Plus Flex Blood Glucose Monitoring System in the hands of the user was conducted. A comparison of the Lay User OneTouch Ultra Plus 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 169 lay persons showed the following results:

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

Within ±5 mg/dL Within ±10 mg/dL Within ±15 mg/dL 75.0% 90.0% 95.0% (19/20) (15/20) (18/20)

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

LifeScan Europe, a Div. of Cilag GmbH International

Page 8 of 15

Part 2 510K Summary

# Confidential and Proprietary Information

Traditional 510(k)

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Image /page/11/Picture/0 description: The image shows the LifeScan logo. The logo features the word "LIFESCAN" in a bold, blue font. Below the word is the phrase "a Johnson & Johnson company" in a smaller, red font. To the left of the word "LIFESCAN" is a blue globe graphic with a curved line above it.

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

# 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% |
|------------|-------------|-------------|-------------|
| 63.1% | 88.6% | 96.0% | 100% |
| (94/149) | (132/149) | (143/149) | (149/149) |

# Subject Results for Glucose concentrations across the glucose range:

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

| Within ± 10mg/dL or ± 15% |
|---------------------------|
| 95.3%<br>(161/169) |

LifeScan Europe, a Div. of Cilag GmbH International

Page 9 of 15

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/12/Picture/0 description: The image contains the logo for LifeScan, a Johnson & Johnson company. The logo features the word "LIFESCAN" in large, bold, blue letters. Below the company name, in a smaller, cursive font, is the text "a Johnson & Johnson company". To the left of the company name is a blue globe graphic with a blue swoosh above the company name.

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

# Precision (Repeatability)

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

| Target Glucose | Mean Glucose | Standard Deviation | Coefficient of |
|----------------|--------------|--------------------|----------------|
| (mg/dL) | (mg/dL) | (mg/dL) | Variation (%) |
| 20 | 19.39 | 0.55 | 2.86 |
| 40 | 34.98 | 0.86 | 2.46 |
| 90 | 98.81 | 1.89 | 1.91 |
| 130 | 139.26 | 2.95 | 2.11 |
| 200 | 222.32 | 4.28 | 1.92 |
| 350 | 382.15 | 8.14 | 2.13 |
| 600 | 641.27 | 13.51 | 2.11 |

Results show that the greatest variability observed between test strips when tested with blood is 1.89mg/dl SD or less at glucose levels less than 100mg/dl, or 2.13% or less at glucose levels at 100mg/dl or above

LifeScan Europe, a Div. of Cilag GmbH International

Page 10 of 15

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/13/Picture/0 description: The image shows the logo for LifeScan, a Johnson & Johnson company. The logo features the word "LIFESCAN" in large, blue, sans-serif font. Below the company name is the text "a Johnson & Johnson company" in a smaller, red, cursive font. To the left of the company name is a blue globe graphic with curved lines above and below.

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

# 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) | 12.39 | 0.47 | 3.76 |
| Low (25 - 49) | 36.87 | 0.97 | 2.62 |
| Mid (102 - 138) | 117.98 | 2.19 | 1.86 |
| High (298 – 403) | 352.03 | 7.92 | 2.25 |
| Very High (446-604) | 520.56 | 12.60 | 2.42 |

# 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 100%, 98.6%, 97.8% within ±15% of the medical laboratory values at glucose concentrations at or above 100mg/dL.

LifeScan Europe, a Div. of Cilag GmbH International Page 11 of 15 Part 2 510K Summary Confidential and Proprietary Information Traditional 510(k) OneTouch Ultra Plus Flex Blood Glucose Monitoring System

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Division of Cilag GmbH International

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

| Test Strip Lot Number | Within ±5mg/dL | Within ±10mg/dL | Within ±15mg/dL |
|-----------------------------|--------------------|--------------------|-------------------|
| A | 61.3%<br>(38/62) | 91.9%<br>(57/62) | 100%<br>(62/62) |
| B | 71.0%<br>(44/62) | 96.8%<br>(60/62) | 100%<br>(62/62) |
| C | 66.1%<br>(41/62) | 93.5%<br>(58/62) | 100%<br>(62/62) |
| Pooled Results for Lots A-C | 66.1%<br>(123/186) | 94.1%<br>(175/186) | 100%<br>(186/186) |

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

#### 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 ±5% | Within ±10% | Within ±15% |
|--------------------------------|--------------------|--------------------|--------------------|
| A | 65.9%<br>(91/138) | 92.0%<br>(127/138) | 100%<br>(138/138) |
| B | 60.9%<br>(84/138) | 92.8%<br>(128/138) | 98.6%<br>(136/138) |
| C | 67.4%<br>(93/138) | 93.5%<br>(129/138) | 97.8%<br>(135/138) |
| Pooled Results for Lots<br>A-C | 64.7%<br>(268/414) | 92.8%<br>(384/414) | 98.8%<br>(409/414) |

#### System accuracy results across the glucose range tested: concentrations between 36.7 to 507.3 mg/dL

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

| Test Strip Lot Number | Within ±15mg/dL or ±15% |
|------------------------|-------------------------|
| A | 100%<br>(200/200) |
| B | 99.0%<br>(198/200) |
| C | 98.5%<br>(197/200) |
| Pooled Results for A-C | 99.2%<br>(595/600) |

LifeScan Europe, a Div. of Cilag GmbH International

Page 12 of 15

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 LifeScan logo. The logo features a blue globe on the left, followed by the word "LIFESCAN" in blue, bold letters. Below the word "LIFESCAN" is the phrase "a Johnson & Johnson company" in a smaller, red, cursive font.

NOTE: Where 36.7 mg/dL represents the lowest glucose reference value and 507.3 mg/dL represents the highest glucose reference value (YSI value).

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

A study to validate the accuracy performance of the OneTouch Ultra Plus Flex Blood Glucose Monitoring System in the hands of the Lay User in accordance with ISO 15197:2013(E) Clause 8 was performed. A comparison of the Lay User OneTouch Ultra Plus Flex Blood Glucose Monitoring System fingertip results to the 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 166 lay persons showed the following results:

96.8% within ±15mg/dl of the glucose reference (YSI) values at glucose concentrations below 100mg/dL and 97.0% within ±15% of the medical laboratory values at glucose concentrations at or above 100mg/dL.

97.0% 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 |
|-----------------|------------------|------------------|
| 71.0% | 87.1% | 96.8% |
| (22/31) | (27/31) | (30/31) |

LifeScan Europe, a Div. of Cilag GmbH International

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/16/Picture/0 description: The image shows the LifeScan logo, which includes a blue globe graphic on the left side. The text "LIFESCAN" is written in large, bold, blue letters. Below the main text, in smaller red cursive font, it says "a Johnson & Johnson company".

Division of Cilag GmbH International

Gubelstrasse 34 , CH-6300 Zug, Switzerland

# 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% |
|------------|-------------|-------------|
| 65.2% | 89.6% | 97.0% |
| (88/135) | (121/135) | (131/135) |

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

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

| Within ±15 mg/dL (±0.83 mmol/L) or ±15% | | |
|-----------------------------------------|-----------|--|
| 97.0% | (161/166) | |

LifeScan Europe, a Div. of Cilag GmbH International

Page 14 of 15

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)

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Image /page/17/Picture/0 description: The image shows the LifeScan logo, which includes a blue globe on the left side. The words "LIFESCAN" are written in blue, and below that, in red cursive, it says "a Johnson & Johnson company". The logo is clean and professional, suggesting a reputable and established company.

LifeScan 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 Ultra Plus Flex 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 Ultra Plus Flex System also meets the requirements of ISO15197:2013 and applicable recognized electrical and safety standards including FCC requirements.

#### Conclusions

The OneTouch Ultra Plus 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

Part 2 510K Summary

Confidential and Proprietary Information

Traditional 510(k)