The OneTouch Verio Reflect Blood Glucose Monitoring System is composed of the OneTouch Verio Reflect Meter and OneTouch Verio Test Strips. The OneTouch Verio Reflect 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 fingertips. The OneTouch Verio Reflect Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.

Device Description

The OneTouch Verio Reflect Blood Glucose Monitoring System consists of the OneTouch Verio Reflect Blood Glucose Meter, OneTouch Verio Test Strips, OneTouch Verio Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Reflect 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 OneTouch Verio Reflect meter also contains tools to aid diabetes management which include a dynamic range indicator, test tracker, blood sugar mentor, trend90 average blood glucose and meal and advanced tagging.

AI/ML Overview

The OneTouch Verio Reflect Blood Glucose Monitoring System was evaluated for its accuracy in a Lay User Method Comparison Study. The study assessed the device's performance against a laboratory reference method, the Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer).

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (October 2016))	Reported Device Performance (OneTouch Verio Reflect Blood Glucose Monitoring System)
For glucose concentrations ≥ 75 mg/dL: At least 95% of results must be within ±15% of the reference method.	99.2% of results were within ±15% of the YSI 2300 reference instrument.
For glucose concentrations < 75 mg/dL: At least 95% of results must be within ±15 mg/dL of the reference method.	No specific detailed breakdown for concentrations < 75 mg/dL provided in the summary table, but the overall 99.2% within ±15% performance suggests this criterion was met.

2. Sample Size and Data Provenance:

Sample Size for Test Set: 354 lay persons (fingertip capillary blood samples).
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a "Lay User Method Comparison Study" conducted for regulatory submission, it is highly likely to be a prospective study.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable in this context. The ground truth for glucose concentration was established by a laboratory reference instrument (YSI 2300 STAT PLUS glucose analyzer), not human expert interpretation.

4. Adjudication Method:

Not applicable. The ground truth was established by a laboratory instrument, not human review requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This device is a blood glucose monitoring system, and its performance is assessed against a laboratory reference standard, not through a comparative study with human readers (with or without AI assistance).

6. Standalone (Algorithm Only) Performance:

The reported performance is the standalone performance of the device as used by lay users, essentially the algorithm's performance in determining glucose levels from the test strip sample. No "human-in-the-loop" was involved in the measurement process for the reported accuracy.

7. Type of Ground Truth Used:

Instrument-based reference measurement: Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer).

8. Sample Size for Training Set:

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms as would typically be described for image analysis devices. The "blood glucose algorithm" mentioned is likely part of the device's core operating principle, which would be developed and validated through extensive R&D and analytical studies rather than a distinct training set for a machine learning model.

9. How Ground Truth for Training Set was Established:

Not explicitly stated regarding a distinct "training set" as commonly understood in AI/ML. The device's underlying algorithm development would have relied on a combination of chemical principles, laboratory measurements, and potentially large datasets of glucose readings and interfering substances to refine its accuracy and interference reduction capabilities.

Summary

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February 14, 2020

LifeScan Europe GmbH Niki Skelly Regulatory Affairs Consultant LifeScan Scotland Ltd. Beechwood Park North, Inverness, GB iv1 3ed Scotland

Re: K193475

Trade/Device Name: OneTouch Verio Reflect Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: December 13, 2019 Received: December 16, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Marianela Perez-Torres, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193475

Device Name

OneTouch Verio Reflect Blood Glucose Monitoring System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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OneTouchVerio Reflect Blood Glucose Monitoring System Traditional 510(k)

510(k) Summary

(as required by section 807.92(c))

The assigned 510(k) number is K193475

The assigned 510(k) number is K190476
Sponsor	LifeScan Europe GmbHGubelstrasse 34Zug, Switzerland 6300
Correspondent	Niki Skelly, Regulatory Affairs SpecialistLifeScan Scotland Ltd.Beechwood Park NorthInverness, IV2 3EDUnited KingdomPhone: +44(0) 1463 383735e-mail: nskelly@lifescan.comAlternate 510(k) Contact:Alison Wilson, Director Regulatory AffairsLifeScan Scotland LtdBeechwood Park NorthInverness, IV2 3EDUnited KingdomPhone: +44 01463 383615Fax: +44 (0)1463 722000e-mail: awilson@lifescan.com

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Date Prepared	December 3rd, 2019
Device Trade Name	OneTouch Verio Reflect Blood Glucose Monitoring System
Common Name	Glucose Test System
Classification	OneTouch Verio Reflect Blood Glucose Meters and OneTouchVerio Test Strips are Class II devices (21 CFR § 862.1345),Product Code NBW
Description	The OneTouch Verio Reflect Blood Glucose MonitoringSystem consists of the OneTouch Verio Reflect Blood GlucoseMeter, OneTouch Verio Test Strips, OneTouch Verio Level 3and Level 4 Control Solutions, Lancing Device and SterileLancets. The OneTouch Verio Reflect Blood GlucoseMonitoring System measures the glucose content of a bloodsample by means of an electrical current produced in the teststrip and sent to the meter for measurement. The OneTouchVerio Reflect meter also contains tools to aid diabetesmanagement which include a dynamic range indicator, testtracker, blood sugar mentor, trend90 average blood glucose andmeal and advanced tagging.
Predicate Device	OneTouch Verio Flex Blood Glucose Monitoring System(K150214, Cleared 31st July 2015)
IntendedUse/Indications forUse	The OneTouch Verio Reflect Blood Glucose MonitoringSystem is composed of the OneTouch Verio Reflect Meter andOneTouch Verio Test Strips. The OneTouch Verio ReflectBlood Glucose Monitoring System is intended to be used forthe quantitative measurement of glucose (sugar) in fresh

LifeScan Europe GmbH

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	capillary whole blood samples drawn from the fingertips. TheOneTouch Verio Reflect Blood Glucose Monitoring System isintended for self-testing outside the body (in-vitro diagnosticuse), by individuals with diabetes at home as an aid to monitorthe effectiveness of diabetes control. This system is intended tobe used by a single person and should not be shared. Thesystem should not be used for the diagnosis of, or screening fordiabetes or for neonatal use.
Comparison toPredicate Device	The Subject device is different from the predicate device in thefollowing aspects:
	Meter:
	● Blood Glucose Algorithm: A modified blood glucosecalculation, reduces sensitivity to interferences andincludes additional error trap failsafe mode for samplemis-application.
	● Software/Firmware changes: Dynamic Color RangeIndicator, Blood Sugar Mentor for motivationalmessages, Test tracker, Meal and Advanced tagging(Carbs, Stress, Illness, Meds, Exercise), Resultssummary charts, Averages (Before and After Meal),Trend 90 feature for 90 day blood glucose average.
	● Ergonomic/physical Design: Changes to size, shape
	● Electronic/hardware: use of 2x coin cell battery instead of 1,separation of Multichip module constituent parts, TFT (ThinFilm Transistor) Color LCD display and addition ofbacklight on the meter display

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	• Labelling:• New branding and Instructions for UseThere are no changes to the OneTouch Verio Test Strips or theOneTouch Verio Level 3 and Level 4 Control Solutions clearedfor use with the predicate OneTouch Verio Flex Blood GlucoseMonitoring System 510(k) (K150214).There have been no changes to the intended use, operatingprinciple or scientific technology.
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Technological Characteristics

Specifications andFeatures	OneTouch Verio FlexBlood GlucoseMonitoring System(Predicate Device)	OneTouch Verio ReflectBlood GlucoseMonitoring System(Subject Device)
Scientific Technology	Amperometric detection	Same
Operating Principle	Electrochemical reactionwith GDH-FAD GlucoseDehydrogenase	Same
Calibration	Plasma-equivalent	Same
Sample Site	Fingertip only	Same
Sample Type	Capillary	Same
Sample Volume	Minimum 0.4ul	Same
Test Time	5 seconds	Same
Glucose Measurement	20 - 600 mg/dL (1.1 - 33.3	Same
Specifications andFeatures	OneTouch Verio FlexBlood GlucoseMonitoring System(Predicate Device)	OneTouch Verio ReflectBlood GlucoseMonitoring System(Subject Device)
Range	mmol/L)
Hematocrit Range	20-60%	Same
Operating TemperatureRange	10°C – 40°C (50°F –104°F)	6°C - 44°C (43°F –111°F)
Operating RelativeHumidity Range	10 % - 90%, non-condensing	Same
Test Strip Storage(Unopened Vial)	22 months5°C - 30°C (41°F - 86°F)up to 65% RH	22 months5°C - 30°C (41°F - 86°F)10-90% RH
Test Strip Storage (OpenedVial)	6 months from firstopening	Same
	Level 3 : target glucoseconcentration 120 mg/dL;Range 102 - 138 mg/dL(5.7 - 7.7 mmol/L)	Same
Control Solution Ranges	Level 4 : target glucoseconcentration 350 mg/dL;Range 298 - 403 mg/dL(16.5 - 22.4 mmol/L)
Coding	No calibration code isrequired	Same
Data Download	Via USB or Bluetooth	Same
Specifications andFeatures	OneTouch Verio FlexBlood GlucoseMonitoring System(Predicate Device)	OneTouchVerio ReflectBlood GlucoseMonitoring System(Subject Device)
	Low Energy
Compatible off-metersoftware accessories	OneTouch Reveal	Same
Power source	1 x 3V CR2032	2 x 3V CR2032
Meter Size(L x W x H)	Approx 3.39 x 2.05 x 0.63inches	Approx 3.97 x 1.69 x 0.61inches
Weight	Approx 1.7 ounces	Approx 1.9 ounces
User Interface Screen	No Menu or textGraphics to instruct user toapply sample to strip	Menu driven with text andicon based information.

LifeScan Europe GmbH

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LifeScan Europe GmbH

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Summary of Performance Characteristics

The OneTouch Verio Reflect Blood Glucose Monitoring System (meter, strips, and control solutions) was designed and tested in accordance with FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (October 2016) and EN ISO 15197:2015. Analytical performance testing included, repeatability, intermediate precision hematocrit, short sample volume, perturbation, interference and linearity testing. A user performance evaluation was also conducted in accordance with FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (October 2016; Section VI.C) which assessed accuracy of results and usability of the device in the hands of

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The OneTouch Verio Reflect Blood Glucose Monitoring System intended users. performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI 2300 STAT PLUS glucose analyzer).

Lay User Method Comparison Study

A Lay User Method Comparison study of the OneTouch Verio Reflect Blood Glucose Monitoring System (BGMS) was conducted in accordance with FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (October 2016; Section VI.C) to validate the accuracy performance of the System in the hands of the user. A comparison of the Lay User OneTouch Verio Reflect 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 from 354 lay persons showed the following results:

Verio Reflect User Evaluation Performance – Summary of data within specified mg/dL of the YSI 2300 reference instrument for glucose concentrations across the entire range:

	Within ±5%	Within ±10%	Within ±15%	Within ±20%
Dataset	n (%)	n (%)	n (%)	n (%)
Subject	222/354	333/354	351/354	354/354
self-test	(62.7)	(94.1)	(99.2)	(100)

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Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence

Design verification and validation testing confirmed that the performance, safety, and effectiveness of the OneTouch Verio Reflect 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. Evaluations included repeatability, intermediate precision and linearity. The OneTouch Verio Reflect Meter also meets the requirements of FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (October 2016), EN ISO 15197:2015 and applicable recognized electrical and safety standards including FCC requirements.

Conclusions

The OneTouch Verio Reflect 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 Flex Blood Glucose Monitoring System (K150214).

Regulation Number and Section

§ 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.