(182 days)
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.
The OneTouch Verio Flex Blood Glucose Monitoring System consists of the OneTouch Verio Flex Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio 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.
OneTouch Verio Flex™ Blood Glucose Monitoring System Acceptance Criteria and Study Details
1. Acceptance Criteria and Reported Device Performance
The OneTouch Verio Flex™ Blood Glucose Monitoring System was designed and tested in accordance with ISO 15197:2013(E) guidelines for system accuracy. The key acceptance criteria and reported performance from the device's system accuracy study are summarized below.
Acceptance Criteria per ISO 15197:2013(E) Clause 6.3 - System Accuracy (Healthcare Professional Use):
| Glucose Concentration Range | Acceptance Criterion (Percentage of samples within range) |
|---|---|
| < 100 mg/dL | ≥ 95% of results within ±15 mg/dL |
| ≥ 100 mg/dL | ≥ 95% of results within ±15% |
| Overall (Combined) | ≥ 95% of results within ±15 mg/dL or ±15% |
Reported Device Performance (Healthcare Professional Use):
| Glucose Concentration Range | Reported Performance (Percentage of samples within range) |
|---|---|
| < 100 mg/dL | 100% of results within ±15 mg/dL (Pooled Lots A-C) |
| ≥ 100 mg/dL | 99.3% of results within ±15% (Pooled Lots A-C) |
| Overall (Combined) | 99.5% of results within ±15 mg/dL or ±15% (Pooled Lots A-C) |
Acceptance Criteria per ISO 15197:2013(E) Clause 8 - User Performance Evaluation (Lay User):
| Glucose Concentration Range | Acceptance Criterion (Percentage of samples within range) |
|---|---|
| < 100 mg/dL | ≥ 95% of results within ±15 mg/dL |
| ≥ 100 mg/dL | ≥ 95% of results within ±15% |
| Overall (Combined) | ≥ 95% of results within ±15 mg/dL or ±15% |
Reported Device Performance (Lay User Performance Evaluation):
| Glucose Concentration Range | Reported Performance (Percentage of samples within range) |
|---|---|
| < 100 mg/dL | 93.1% of results within ±15 mg/dL (Note: This is below the ISO 95% criterion) |
| ≥ 100 mg/dL | 98.6% of results within ±15% |
| Overall (Combined) | 97.6% of results within ±15 mg/dL or ±15% |
Note on Lay User Performance: While the overall and ≥100 mg/dL results met the ISO 15197:2013(E) Clause 8 criteria, the performance for glucose concentrations <100 mg/dL was 93.1%, which is below the 95% acceptance criterion mentioned in the ISO standard for this range. However, the summary statement on page 15 still concludes that the system meets "all design input specifications" and ISO 15197:2013 requirements, suggesting that possibly the specific internal acceptance criteria for this portion might have been different or considered acceptable within the context of the overall system accuracy. Without further information, this discrepancy for the <100 mg/dL range in lay user performance is noted.
2. Sample size used for the test set and the data provenance
Method Comparison Performance (Healthcare Professional Use):
- Sample Size: 115 subjects
- Data Provenance: Not explicitly stated, but implies prospective collection as it involved "fingersick samples from diabetic subjects" and testing against a reference method. The location is not specified.
System Accuracy in compliance with ISO 15197:2013(E) Clause 6.3 (Healthcare Professional Use):
- Sample Size: 100 subjects
- Data Provenance: Not explicitly stated, but implies prospective collection as it involved "fingertip capillary blood samples obtained by healthcare professionals". The location is not specified.
Lay User Performance Evaluation (Clause 8, first study summary):
- Sample Size: 172 lay persons
- Data Provenance: Not explicitly stated, but implies prospective collection as it involved "fingertip capillary blood samples obtained by lay persons". The location is not specified.
User Performance Evaluation in compliance with ISO 15197:2013(E) Clause 8 (second study summary):
- Sample Size: 167 lay persons
- Data Provenance: Not explicitly stated, but implies prospective collection as it involved "fingertip capillary blood samples obtained by lay persons". The location is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth. Instead, the ground truth was established using a recognized laboratory reference method: the Yellow Springs Instrument (YSI) 2300 (or YSI 2300 STAT PLUS) glucose analyzer. This instrument itself is considered the "expert" for generating accurate glucose measurements.
4. Adjudication method for the test set
Not applicable. The ground truth was established by a laboratory reference instrument (YSI analyzer), not by human experts requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging or interpretation tool that involves "human readers." Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The "Method Comparison Performance" study and the "System Accuracy in compliance with ISO 15197:2013(E) Clause 6.3" study assessed the device's accuracy when operated by healthcare professionals, comparing its readings directly to the laboratory reference method (YSI). This represents the algorithm's performance with trained users, effectively functioning as a standalone assessment of the device's accuracy in a controlled environment. The "Lay User Performance Evaluation" also assessed the device's accuracy when operated by intended users, albeit with human interaction in using the device.
7. The type of ground truth used
The ground truth used was laboratory reference measurements obtained from a Yellow Springs Instrument (YSI) 2300 (or YSI 2300 STAT PLUS) glucose analyzer. This is considered a highly accurate and recognized method for determining glucose concentrations.
8. The sample size for the training set
The document does not provide a sample size specifically for a "training set." Blood glucose monitoring systems like the OneTouch Verio Flex™ typically do not use machine learning models that require a separate training set in the same way AI algorithms do. The development process would involve calibration and optimization based on chemical and electrical principles rather than iterative training on a dataset. The studies described are validation studies.
9. How the ground truth for the training set was established
As noted above, the concept of a "training set" in the context of machine learning does not directly apply to this device. For the development and calibration of the glucose monitoring system, the ground truth would have been established through highly accurate laboratory reference methods (like those provided by a YSI analyzer) during the chemical and electrical engineering phases, prior to the validation studies described in the document. The document doesn't detail these initial development and calibration phases.
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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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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 InternationalGubelstrasse 34Zug, Switzerland 6300 |
|---|---|
| Correspondent | Alison Wilson, Regulatory Affairs Project ManagerLifeScan Scotland Ltd.Beechwood Park NorthInverness, IV2 3EDUnited KingdomPhone: +44(0) 1463 721256e-mail: awilson4@its.jnj.comAlternate 510(k) Contact:Oyinkan Donaldson, Senior Regulatory Affairs ManagerLifeScan Scotland LtdBeechwood Park NorthInverness, IV2 3EDUnited KingdomPhone: +44 01463 721259Mobile: +44 (0) 7909935151Fax: +44 (0)1463 722000e-mail: odonalds@its.jnj.com |
| 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
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Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
| Classification | OneTouch Verio Flex™ Blood Glucose Meters and OneTouch Verio™Test Strips are Class II devices (21 CFR § 862.1345), Product CodeNBW, LFROneTouch Verio™ Control Solutions are Class I devices (21 CFR§862.1660), Product Code JJXLancing Device and Sterile Lancets are Class I (exempt) devices (21CFR § 878.4800), Product Code FMK | |
|---|---|---|
| System Description | The OneTouch Verio Flex Blood Glucose Monitoring System consistsof the OneTouch Verio Flex Blood Glucose Meter, OneTouch® Verio®Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions,Lancing Device and Sterile Lancets. The OneTouch Verio Flex BloodGlucose Monitoring System measures the glucose content of a bloodsample by means of an electrical current produced in the test strip andsent to the meter for measurement. | |
| Predicate Device | OneTouch® Verio™ Blood Glucose Monitoring System (K131363,Cleared 30th August 2013) | |
| IntendedUse/Indications forUse | The OneTouch Verio Flex Blood Glucose Monitoring System isintended to be used for the quantitative measurement of glucose (sugar)in fresh capillary whole blood samples drawn from the fingertip. TheOneTouch Verio Flex Blood Glucose Monitoring System is intended tobe used by a single patient and should not be shared.OneTouch Verio Flex Blood Glucose Monitoring System is intended forself testing outside the body (in vitro diagnostic use) by people withdiabetes at home as an aid to monitor the effectiveness of diabetescontrol. The OneTouch Verio Flex Blood Glucose MonitoringSystem 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 OneTouchVerio Flex Blood Glucose Meter to quantitatively measure glucosedrawn from the fingertips. | ||
| Comparison toPredicate Device | The Subject device is different from the predicate device in thefollowing aspects:• Meter:○ Ergonomic/physical design: Changes to size, shape and color○ Electronic/hardware: Strip port connector○ Software/Firmware changes: Modified Blood GlucoseAlgorithm and addition of a range indicator software feature.• Labelling:○ New branding and Instructions for UseThere are no changes to the OneTouch® Verio® Test Strips or theOneTouch® Verio® Level 3 (Mid) and Level 4 (High) Control Solutionscleared for use with the predicate OneTouch® Verio™ Blood GlucoseMonitoring System 510(k) (K131363).There have been no changes to the intended use, operating principle orscientific technology. | |
| TechnologicalCharacteristics | There has been no change to the fundamental scientific technology,which is amperometric detection. The operating principle remainselectrochemical reaction. | |
| Summary ofPerformanceCharacteristics | The OneTouch Verio Flex Blood Glucose Monitoring System (meter,strips, and control solutions) was designed and tested in accordance withISO 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
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Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
LifeScan Europe, a Div. of Cilag GmbH International
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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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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%(341/345) | 99.4%(343/345) |
LifeScan Europe, a Div. of Cilag GmbH International
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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 # | #Participants | #Tests | Slope[95% CI] | Intercept[95% CI](mg/dL) | Std.Error(Sy.x)(mg/dL) | R2 |
|---|---|---|---|---|---|---|---|
| OneTouch® Verio™ | D | 115 | 115 | 0.97[0.95 to 0.99] | 6.05[2.41 to 9.69] | 10.15 | 0.99 |
| OneTouch®VerioFlex™ | A | 115 | 115 | 1.00[0.98 to 1.02] | -0.31[-4.04 to3.42] | 10.41 | 0.99 |
| B | 115 | 115 | 0.99[0.97 to 1.01] | 1.14[-2.91 to5.20] | 11.33 | 0.99 | |
| C | 115 | 115 | 1.01[0.99 to 1.03] | 0.01[-4.13 to4.16] | 11.57 | 0.99 | |
| 3 lots | 345 | 345 | 1.00[0.99 to 1.01] | 0.28[-2.00 to2.56] | 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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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 | Confidential and Proprietary Information |
| Traditional 510(k) | OneTouch Verio FlexTM Blood Glucose Monitoring System |
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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 LevelRanges(mg/dL) | Mean Glucose(mg/dL) | Standard Deviation(mg/dL) | Coefficient ofVariation (%) |
|---|---|---|---|
| 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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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%(43/50) | 98%(49/50) | 100%(50/50) |
| B | 80%(40/50) | 98%(49/50) | 100%(50/50) |
| C | 80%(40/50) | 98%(49/50) | 100%(50/50) |
| Pooled Results for Lots A-C | 82.0%(123/150) | 98.0%(147/150) | 100%(150/150) |
System Accuracy Results for Glucose Concentrations ≥100 mg/dL
Percent (and number) of meter results that match the YSI reference
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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%(98/150) | 93.3%(140/150) | 99.3%(149/150) |
| B | 64.0%(96/150) | 96.0%(144/150) | 100%(150/150) |
| C | 59.3%(89/150) | 94.7%(142/150) | 98.7%(148/150) |
| Pooled Results for LotsA-C | 62.9%(283/450) | 94.7%(426/450) | 99.3%(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%(199/200) |
| B | 100%(200/200) |
| C | 99.0%(198/200) |
| Pooled Results for A-C | 99.5%(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 |
|---|---|
| Part 2 510K Summary | Confidential and Proprietary Information |
| 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%(81/138) | 88.4%(122/138) | 98.6%(136/138) |
Results for Glucose concentrations across the glucose range:
LifeScan Europe, a Div. of Cilag GmbH International
Page 11 of 13
Part 2 510K Summary
Traditional 510(k)
OneTouchVerio Flex™ Blood Glucose Monitoring System
Confidential and Proprietary Information
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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)
§ 862.1345 Glucose test system.
(a)
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.(b)
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.