(60 days)
Not Found
Unknown
The summary mentions "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." While these features suggest some level of data processing and potentially predictive or advisory functions ("blood sugar mentor"), the summary does not explicitly state that AI or ML is used to power these features. The description of the glucose measurement method is based on electrical current, not image processing or other modalities typically associated with AI/ML in this context. There is no mention of training or test sets for AI/ML models. Therefore, it is not possible to definitively confirm the presence of AI/ML based on the provided text.
No.
The device is described as an in-vitro diagnostic system intended to measure glucose levels as an aid to monitor the effectiveness of diabetes control, not to actively treat or modify a physiological function.
No
The device is intended to monitor the effectiveness of diabetes control, not for the diagnosis or screening of diabetes.
No
The device description explicitly lists hardware components such as the meter, test strips, control solutions, lancing device, and lancets, indicating it is a physical system, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The OneTouch Verio Reflect Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use)..."
N/A
Intended Use / Indications for Use
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.
Product codes
NBW
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertips
Indicated Patient Age Range
Not Found
Intended User / Care Setting
individuals with diabetes at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies
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 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).
Study type: Lay User Method Comparison Study
Sample size: 354 lay persons
Key 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% (62.7%), Within ±10% (94.1%), Within ±15% (99.2%), Within ±20% (100%).
Key Metrics
Within ±5% (62.7%)
Within ±10% (94.1%)
Within ±15% (99.2%)
Within ±20% (100%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
- 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)
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.
| 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 word "Lifescan" is written in a stylized, cursive font in blue. To the right of the word is a graphic of a sphere made up of dots in shades of purple and pink. The dots appear to be dispersing from the sphere.
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 GmbH |
| Gubelstrasse 34 | |
| Zug, Switzerland 6300 | |
| Correspondent | Niki Skelly, Regulatory Affairs Specialist |
| LifeScan Scotland Ltd. | |
| Beechwood Park North | |
| Inverness, IV2 3ED | |
| United Kingdom | |
| Phone: +44(0) 1463 383735 | |
| e-mail: nskelly@lifescan.com |
Alternate 510(k) Contact:
Alison Wilson, Director Regulatory Affairs
LifeScan Scotland Ltd
Beechwood Park North
Inverness, IV2 3ED
United Kingdom
Phone: +44 01463 383615
Fax: +44 (0)1463 722000
e-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 OneTouch |
| Verio Test Strips are Class II devices (21 CFR § 862.1345), | |
| Product Code NBW | |
| 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. | |
| Predicate Device | OneTouch Verio Flex Blood Glucose Monitoring System |
| (K150214, Cleared 31st July 2015) | |
| Intended | |
| Use/Indications for | |
| Use | 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 |
LifeScan Europe GmbH
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| | 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. | | |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Comparison to
Predicate Device | The Subject device is different from the predicate device in the
following aspects: | | |
| | Meter: | | |
| | ● Blood Glucose Algorithm: A modified blood glucose
calculation, reduces sensitivity to interferences and
includes additional error trap failsafe mode for sample
mis-application. | | |
| | ● Software/Firmware changes: Dynamic Color Range
Indicator, Blood Sugar Mentor for motivational
messages, Test tracker, Meal and Advanced tagging
(Carbs, Stress, Illness, Meds, Exercise), Results
summary 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 (Thin
Film Transistor) Color LCD display and addition of
backlight on the meter display | | |
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| | • Labelling:
• New branding and Instructions for Use
There are no changes to the OneTouch Verio Test Strips or the
OneTouch Verio Level 3 and Level 4 Control Solutions cleared
for use with the predicate OneTouch Verio Flex Blood Glucose
Monitoring System 510(k) (K150214).
There have been no changes to the intended use, operating
principle or scientific technology. |
| -- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Technological Characteristics
| Specifications and
Features | OneTouch Verio Flex
Blood Glucose
Monitoring System
(Predicate Device) | OneTouch Verio Reflect
Blood Glucose
Monitoring System
(Subject Device) |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Scientific Technology | Amperometric detection | Same |
| Operating Principle | Electrochemical reaction
with GDH-FAD Glucose
Dehydrogenase | 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 and
Features | OneTouch Verio Flex
Blood Glucose
Monitoring System
(Predicate Device) | OneTouch Verio Reflect
Blood Glucose
Monitoring System
(Subject Device) |
| Range | mmol/L) | |
| Hematocrit Range | 20-60% | Same |
| Operating Temperature
Range | 10°C – 40°C (50°F –
104°F) | 6°C - 44°C (43°F –
111°F) |
| Operating Relative
Humidity Range | 10 % - 90%, non-
condensing | Same |
| Test Strip Storage
(Unopened Vial) | 22 months
5°C - 30°C (41°F - 86°F)
up to 65% RH | 22 months
5°C - 30°C (41°F - 86°F)
10-90% RH |
| Test Strip Storage (Opened
Vial) | 6 months from first
opening | Same |
| | Level 3 : target glucose
concentration 120 mg/dL;
Range 102 - 138 mg/dL
(5.7 - 7.7 mmol/L) | Same |
| Control Solution Ranges | Level 4 : target glucose
concentration 350 mg/dL;
Range 298 - 403 mg/dL
(16.5 - 22.4 mmol/L) | |
| Coding | No calibration code is
required | Same |
| Data Download | Via USB or Bluetooth | Same |
| Specifications and
Features | OneTouch Verio Flex
Blood Glucose
Monitoring System
(Predicate Device) | OneTouchVerio Reflect
Blood Glucose
Monitoring System
(Subject Device) |
| | Low Energy | |
| Compatible off-meter
software 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 0.63
inches | Approx 3.97 x 1.69 x 0.61
inches |
| Weight | Approx 1.7 ounces | Approx 1.9 ounces |
| User Interface Screen | No Menu or text
Graphics to instruct user to
apply sample to strip | Menu driven with text and
icon 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
9
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).