(182 days)
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. The 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.
The OneTouch Ultra Plus Flex Blood Glucose Monitoring System consists of the OneTouch Ultra Plus Flex Blood Glucose Meter, OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Level 3 and 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.
The provided text describes the performance of the OneTouch Ultra Plus Flex Blood Glucose Monitoring System, particularly its accuracy against specific criteria and a reference method.
Here's an analysis based on the provided text to address your points:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is assessed in accordance with ISO 15197:2013(E) Clause 6.3 (System Accuracy) and Clause 8 (User Performance Evaluation). The acceptance criteria for blood glucose monitoring systems, as per ISO 15197:2013, dictate that for glucose concentrations <100 mg/dL, 95% of the values must fall within ±15 mg/dL of the reference measurement, and for glucose concentrations ≥100 mg/dL, 95% of the values must fall within ±15% of the reference measurement.
| Metric / Glucose Range | Acceptance Criteria (ISO 15197:2013) | Reported Device Performance (System Accuracy, Healthcare Professionals) (Page 14) | Reported Device Performance (Lay User Performance) (Page 15-16) |
|---|---|---|---|
| System Accuracy (<100 mg/dL) | ≥95% within ±15 mg/dL | 100% within ±15 mg/dL (Pooled Results for Lots A-C) | 96.8% within ±15 mg/dL |
| System Accuracy (≥100 mg/dL) | ≥95% within ±15% | 98.8% within ±15% (Pooled Results for Lots A-C) | 97.0% within ±15% |
| System Accuracy (Overall Glucose Range) | Not explicitly stated as overall, but implied by above | 99.2% within ±15mg/dL or ±15% (Pooled Results for A-C) | 97.0% within ±15 mg/dL or ±15% |
2. Sample Size Used for the Test Set and Data Provenance
-
System Accuracy (Healthcare Professionals):
- Sample Size: 100 subjects (Page 13) resulting in 600 total meter results (200 per test strip lot across 3 lots) (Page 14).
- Data Provenance: The study was conducted on "fingertip capillary blood samples obtained by healthcare professionals". The country of origin is not explicitly stated, but the company is based in Switzerland with a consultant in the UK, suggesting European data. The nature is prospective, as samples were "obtained by healthcare professionals" for the study.
-
Lay User Performance Evaluation:
- Sample Size: 166 lay persons (Page 15).
- Data Provenance: "fingertip capillary blood samples obtained by 166 lay persons". Country of origin not specified, but likely similar to the professional study. The nature is prospective.
-
Method Comparison Performance (initial study with healthcare professionals):
- Sample Size: 113 subjects (Page 9) focusing on "first test sample data".
- Data Provenance: "glucose values from the OneTouch Ultra Plus Flex Blood Glucose Monitoring System (obtained by healthcare professional fingersick samples from diabetic subjects)". Prospective data, likely similar geographical origin.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by a laboratory reference method, the Yellow Springs Instrument (YSI) 2300 STAT PLUS glucose analyzer. This is an automated analytical instrument, not human experts. Therefore, the concept of "number of experts" and their "qualifications" for ground truth establishment does not apply in this context.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth is an objective laboratory reference measurement (YSI analyzer), not human readers 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
An MRMC study was not conducted. This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would typically involve human readers. The effectiveness is measured by the device's accuracy against a laboratory reference.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
This is an inherent aspect of the device's design. The system automatically measures glucose and provides a reading. The "System Accuracy" and "Lay User Performance Evaluation" studies demonstrate the standalone performance of the device (meter and test strips) in conjunction with samples from healthcare professionals or lay users, respectively. It is an "algorithm only" performance in the sense that the device performs the measurement autonomously following sample application.
7. The Type of Ground Truth Used
The ground truth used in these studies is a recognized laboratory reference method: the Yellow Springs Instrument (YSI) 2300 STAT PLUS glucose analyzer. This is an objective, quantitative measurement, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI models. This device is a traditional electrochemical blood glucose meter. Its "training" or development would involve engineering design, calibration, and extensive analytical testing (e.g., repeatability, linearity, interference) rather than machine learning on a large dataset. Therefore, a specific "training set sample size" as is common with AI/ML devices is not provided or applicable in the traditional sense. The development of the device would have involved internal validation and calibration procedures.
9. How the Ground Truth for the Training Set Was Established
As noted above, a "training set" in the context of AI/ML is not directly applicable. The device's foundational accuracy and calibration would have been established through rigorous analytical testing during its development, likely using traceable glucose standards and established laboratory methods. The document mentions that the system was "designed and tested in accordance with ISO 15197:2013(E)." This standard outlines requirements for system accuracy, which inherently relies on comparison to a recognized reference method (like YSI).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and an abstract symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. The abstract symbol is composed of three stylized human profiles facing to the right, stacked on top of each other.
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 (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,
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 InternationalGubelstrasse 34Zug, Switzerland 6300 |
|---|---|
| Correspondent | Niki Skelly, Regulatory Affairs ConsultantLifeScan Scotland Ltd.Beechwood Park NorthInverness, IV2 3EDUnited KingdomPhone: +44(0) 1463 721652Mobile : +44(0) 7818 523098e-mail: nskelly@its.jnj.comAlternate 510(k) Contact:Alison Wilson, Regulatory Affairs Project ManagerLifeScan Scotland LtdBeechwood Park NorthInverness, IV2 3EDUnited KingdomPhone: +44 01463 721256Mobile: +44 (0) 7900 168332Fax: +44 (0)1463 722000e-mail: awilson4@its.jnj.com |
| 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 UltraPlus Test Strips are Class II devices (21 CFR § 862.1345), ProductCode NBW, LFR |
| System Description | The OneTouch Ultra Plus Flex Blood Glucose Monitoring Systemconsists of the OneTouch Ultra Plus Flex Blood Glucose Meter,OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Level 3 andLevel 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,Cleared 30th August 2013) |
| IntendedUse/Indications forUse | The OneTouch Ultra Plus 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 Ultra Plus Flex Blood Glucose Monitoring System isintended to be used by a single patient and should not be shared.The OneTouch Ultra Plus Flex Blood Glucose Monitoring System isintended for self testing outside the body (in vitro diagnostic use) bydiabetes control. The OneTouch Ultra Plus Flex Blood GlucoseMonitoring System is not to be used for the diagnosis of or screening ofdiabetes, or for neonatal use.The OneTouch Ultra Plus Test Strips are for use with the OneTouchUltra Plus 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: Modified Strip Port Connector andaddition of wireless communications facility• Software/Firmware changes: Modified Blood GlucoseAlgorithm and addition of a range indicator software feature• Labelling: | |
| New branding and Instructions for Use for Meter, Test Stripsand Control Solutions | |
| Strip: | |
| Change to color of spacer layer | |
| Laser line on left strip leg to align with new Strip PortConnector | |
| The only change to the Control Solutions cleared for use with thepredicate OneTouch® Verio™ Blood Glucose Monitoring System 510(k)(K131363) as OneTouch Verio Control Solutions Level 3 (Mid) andLevel 4 (High) is that a new brand name of OneTouch Ultra Plus Level3 (Mid) and Level 4 (High) Control Solutions will be used to alignbranding with the new system; the formula is identical to the clearedControl Solution. The OneTouch Verio Control Solutions will continueto be marketed with the associated cleared BGMS. | |
| 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 Ultra Plus Flex Blood Glucose Monitoring System(meter, strips, and control solutions) was designed and tested inaccordance with ISO 15197:2013(E). Analytical performance testingincluded interference, system accuracy, repeatability, intermediateprecision and linearity testing. A user performance evaluation assessedaccuracy of results and usability of the device in the hands of intendedusers. The OneTouch Ultra Plus Flex Blood Glucose MonitoringSystem performed similarly to both the predicate device and alaboratory reference method, the Yellow Springs Instrument (YSI). |
LifeScan Europe, a Div. of Cilag GmbH International
Page 1 of 15
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Confidential and Proprietary Information
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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
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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)
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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 | MaximumAllowedConcentration(mg/dL) | Does the Maximum AllowedConcentration exceed the HighNormal/TherapeuticEndogenous 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 | MaximumAllowedConcentration(mg/dL) | Does the Maximum AllowedConcentration exceed the HighNormal/TherapeuticEndogenous 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 UltraPlus Flex BloodGlucoseMonitoringsystem not to beused withpatientsundergoingPAM treatment | NoOneTouch Ultra Plus FlexSMBG system is not to be usedwith patients undergoing PAMtreatment: Caution included inproduct 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 | MaximumAllowedConcentration(mg/dL) | Does the Maximum AllowedConcentration exceed the HighNormal/TherapeuticEndogenous Concentration? |
| Xylose | 8.09 | NoOneTouch Ultra Plus FlexSMBG system is not to be usedwith patients undergoing xyloseabsorption treatment:Caution included in productlabelling 3 |
LifeScan Europe, a Div. of Cilag GmbH International
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Confidential and Proprietary Information
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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
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Confidential and Proprietary Information
Traditional 510(k)
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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
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Confidential and Proprietary Information
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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%(43/60) | 95.0%(57/60) | 100%(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%(171/279) | 89.6%(250/279) | 98.6%(275/279) | 100%(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%(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
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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/tests | Slope[95% CI] | Intercept[95% CI](mg/dL) | Std.Error(Sy.x)(mg/dL) | R2 |
|---|---|---|---|---|---|---|
| OneTouchVerio | D | 113 | 0.98[0.96 to 1.00] | 4.86[1.10 to 8.61] | 10.6 | 0.99 |
| OneTouchUltra PlusFlex | A | 113 | 1.02[1.00 to 1.05] | -2.16[-6.66 to 2.33] | 12.7 | 0.99 |
| B | 113 | 0.99[0.97 to 1.01] | -1.54[-5.37 to 2.30] | 10.8 | 0.99 | |
| C | 113 | 1.01[0.99 to 1.02] | -2.33[-5.94 to 1.27] | 10.2 | 0.99 | |
| 3 lots | 339 | 1.01[1.00 to 1.02] | -2.01[-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
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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%(161/169) |
LifeScan Europe, a Div. of Cilag GmbH International
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Confidential and Proprietary Information
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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
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Division of Cilag GmbH International
Gubelstrasse 34 , CH-6300 Zug, Switzerland
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) | 12.39 | 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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Image /page/14/Picture/0 description: The image shows the LifeScan logo, which includes a blue globe on the left side. The text "LIFESCAN" is written in large, bold, blue letters. Below the main text, there is a smaller text that says "a Johnson & Johnson company" in a cursive font.
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%(38/62) | 91.9%(57/62) | 100%(62/62) |
| B | 71.0%(44/62) | 96.8%(60/62) | 100%(62/62) |
| C | 66.1%(41/62) | 93.5%(58/62) | 100%(62/62) |
| Pooled Results for Lots A-C | 66.1%(123/186) | 94.1%(175/186) | 100%(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%(91/138) | 92.0%(127/138) | 100%(138/138) |
| B | 60.9%(84/138) | 92.8%(128/138) | 98.6%(136/138) |
| C | 67.4%(93/138) | 93.5%(129/138) | 97.8%(135/138) |
| Pooled Results for LotsA-C | 64.7%(268/414) | 92.8%(384/414) | 98.8%(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%(200/200) |
| B | 99.0%(198/200) |
| C | 98.5%(197/200) |
| Pooled Results for A-C | 99.2%(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)
§ 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.