Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System

K240640 · Sejoy Biomedical Co., Ltd. · NBW · Oct 8, 2024 · Clinical Chemistry

Device Facts

• Record ID: K240640
• Device Name: Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
• Applicant: Sejoy Biomedical Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy 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. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link 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 Story

System measures glucose in fresh capillary whole blood via quantitative amperometry; uses test strips with glucose dehydrogenase (FAD-GDH) enzyme; blood drawn into reaction cell via capillary action; reaction produces electric current proportional to glucose concentration. Meter displays plasma-equivalent results. Intended for home self-testing by individuals with diabetes. Sejoy Advance Link model includes Bluetooth for wireless data transmission to Glucojoy App; both models feature optional voice output for results and error codes. Users apply blood directly to strip; no manual coding required. System includes control solutions for quality checks. Provides aid in monitoring diabetes control effectiveness. Not for multi-patient use; requires specific disinfection protocols.

Clinical Evidence

Clinical user evaluation study with 352 lay users comparing device results to YSI 2300 laboratory reference method. Accuracy results: 100% of results within ±20% of reference. Additional testing on 100 contrived samples (50 low, 50 high glucose) confirmed 100% accuracy within ±20% of reference. Bench testing included repeatability, intermediate precision, hematocrit effect, and interference testing.

Technological Characteristics

Amperometric glucose test system using FAD-GDH enzyme. Measurement range 20-600 mg/dL. Minimum sample volume 0.6 µL. Bluetooth connectivity (Advance Link model). Powered by battery. Compliant with IEC 60601-1, IEC 60601-1-2, and IEC 60601-1-11. Disinfection validated for 4000 cycles using CaviWipes.

Indications for Use

Indicated for individuals with diabetes for self-testing of glucose in fresh capillary whole blood from the fingertip to monitor diabetes control. Contraindicated for neonatal use, diagnosis or screening of diabetes, critically ill patients, patients in shock, hyperglycemic-hyperosmolar state, severe hypotension, or severe dehydration.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• OneTouch Verio Reflect Glucose Monitoring System (K193475)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2024

Sejoy Biomedical Co., Ltd Yinting Lan Regulatory Affairs Specialist Area C, Building 2, No.365 Wuzhou Road Yuhang Economic Development Zone Hangzhou City, Zhejiang 311100 China

Re: K240640

Trade/Device Name: Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: September 6, 2024 Received: September 6, 2024

Dear Yinting Lan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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For comprehensive regulatory information about medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Joshua Balsam -S

Joshua M. Balsam, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K240640

#### Device Name

Sejoy Advance Link Blood Glucose Monitoring System

Indications for Use (Describe)

The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link 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)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Indications for Use

510(k) Number (if known) K240640

#### Device Name Sejoy Blood Glucose Monitoring System

#### Indications for Use (Describe)

The Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an and 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) | | | |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| | <table border="0"><tr><td><span style="text-decoration:underline;">☐</span> Residential Use (Part 21 CFR 801 Subpart D)</td><td><span style="text-decoration:underline;">☒</span> Over-The-Counter Use (21 CFR 801 Subpart G)</td></tr></table> | <span style="text-decoration:underline;">☐</span> Residential Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration:underline;">☒</span> Over-The-Counter Use (21 CFR 801 Subpart G) |
| <span style="text-decoration:underline;">☐</span> Residential Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration:underline;">☒</span> Over-The-Counter Use (21 CFR 801 Subpart G) | | |

_ | Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# Traditional 510(k)

# 510(k) Summary

# The assigned 510(k) number is K240640

| Sponsor | SEJOY Biomedical Co., Ltd.<br>Area C, Building 2, No.365 Wuzhou Road,Yuhang Economic<br>Development Zone,Hangzhou City, 311100,Zhejiang, China |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Yingting Lan, Regulatory Affairs Specialist<br>Phone:[phone]<br>E-mail:[e-mail] |
| Date Prepared | August 20th, 2024 |
| Device Trade Name | Sejoy Blood Glucose Monitoring System<br>Sejoy Advance Link Blood Glucose Monitoring System |
| Common Name | Glucose Test System |
| Classification | Class II device (21 CFR § 862.1345),<br>Product Code NBW |
| Predicate Device | OneTouch Verio Reflect Glucose Monitoring System (K193475)<br>Product Code NBW |

# Intended Use/Indications For Use

The Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood collected from the fingertip. The Sejoy 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

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person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.

The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Advance Link Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood drawn from the fingertips. The Sejoy Advance Link 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 Summary

The Sejoy Advance Link Blood Glucose Monitoring System is composed of the Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Test Strips, and the Sejoy Blood Glucose Monitoring System is composed of the Sejoy Blood Glucose Meter and Sejoy Blood Glucose Test Strips. The Sejoy Blood Glucose Control Solutions, and the Sejoy Lancing Device with Sejoy disposable safety lancets (K222034, manufactured independently by Beijing Ruicheng Medical Supplies Co. Ltd. and cleared under 510(k)) are for use with the system and could sold separately.

The Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Meter differ only in Bluetooth functionality which is present only in the Sejoy Advance Link Blood Glucose Meter.

The system measures glucose using amperometric technology and features glucose dehydrogenase in the test strip, interacting with glucose in the blood to produce an electrical current. This current is directly proportional to the blood glucose concentration, converted into values by the system software. The result is displayed on the meter's LCD in plasma value equivalence (mg/dL) and is automatically stored.

The following items are included with the system, and are also sold separately:

- · Sejoy Blood Glucose Control Solutions (CTRL1, CTRL2, and CTRL3)

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- Sejoy Lancing Device and Sejoy Disposable Safety Lancets (K222034)
# Comparison to Predicate Device:

| | Predicate Device | Subject Devices | |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|-----------------------------------------------------------------|
| Specifications and<br>Features | OneTouch Verio Reflect Glucose Monitoring<br>System (K193475) | Sejoy Blood<br>Glucose<br>Monitoring<br>Systems | Sejoy<br>Advance Link<br>Blood Glucose<br>Monitoring<br>Systems |
| Intended<br>Use/Indication for<br>use | It is intended to be used for the quantitative<br>measurement of glucose (sugar) in fresh capillary<br>whole blood samples drawn from the fingertips. It<br>is intended for self-testing outside the body (in-<br>vitro diagnostic use), by individuals with diabetes<br>at home as an aid to monitor the effectiveness of<br>diabetes control. This system is intended to be used<br>by a single person and should not be shared. The<br>system should not be used for the diagnosis of, or<br>screening for diabetes or for neonatal use. | Same | |
| Scientific<br>Technology | Amperometric detection | Same | |
| Operating Principle | Electrochemical reaction<br>with GDH-FAD Glucose<br>Dehydrogenase | Same | |
| Calibration | Plasma-equivalent | Same | |
| Sample Site | Fingertip only | Same | |
| Sample Type | Capillary | Same | |
| Sample Volume | Minimum 0.4 ul | Minimum 0.6 ul | |
| Test Time | 5 seconds | Same | |
| Glucose<br>Measurement Range | 20 - 600 mg/dL (1.1 - 33.3 mmol/L) | Same | |
| Hematocrit Range | 20-60% | 15-60% | |
| Operating<br>Environment | 6°C-44°C(43°F−111°F) and 10%-90%, non<br>condensing | 41°F-113°F (5°C-45°C) and<br>10~90% relative humidity | |
| | Predicate Device | Subject Devices | |
| Specifications and<br>Features | OneTouch Verio Reflect Glucose Monitoring<br>System (K193475) | Sejoy Blood<br>Glucose<br>Monitoring<br>Systems | Sejoy<br>Advance Link<br>Blood Glucose<br>Monitoring<br>Systems |
| Test Strip Storage<br>(Unopened Vial) | 22 months<br>5°C - 30°C (41°F – 86°F)<br>up to 65% RH | 24 months<br>33.8°F~86°F (1°C~30°C) and<br>10~90% relative humidity | |
| Test Strip Storage<br>(Opened Vial) | 6 months from first<br>opening | Same | |
| Coding | No calibration code is<br>required | Same | |
| Data Download | Via USB or Bluetooth | Bluetooth Low Energy<br>(Sejoy Advance Link only) | |
| Compatible off-<br>meter<br>software accessories | OneTouch Reveal | None | |
| Power source | 2 x 3V CR2032 | 2 x AAA | |
| Meter Size<br>(L x W x H) | Approx 3.97 x 1.69 x 0.61<br>inches | Approx 3.74 x 2.22 x 0.90<br>inches | |
| Weight | Approx 1.9 ounces | Approx 1.8 ounces | |
| User Interface<br>Screen | Menu driven with text and<br>icon based information. | Same | |

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# Summary of Performance Characteristics

Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System were designed and tested in accordance with FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (September 2020). Analytical performance testing included repeatability, intermediate precision, hematocrit effect, 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 (September 2020; Section VI.C) which assessed the accuracy of results

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and usability of the device in the hands of intended users. SEJOY Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System performed similarly to both the predicate device as well as to a laboratory reference method, the Yellow Springs Instrument (YSI 2300 glucose analyzer).

# User evaluation Comparison Study

A clinical (user evaluation) study was conducted with Sejoy Advance Link Blood Glucose Monitoring System. The Sejoy Advance Link Blood Glucose Meter and Sejoy Blood Glucose Meter differ only in Bluetooth functionality, and therefore this study also supports the accuracy of the Sejoy Blood Glucose Meter.The study comprised evaluating the system accuracy of the Sejoy Advance Link Blood Glucose Monitoring System by 352 lay persons representative of the age, gender, education of the intended users in the US that self-tested their capillary whole blood and compared to the YSI 2300 STAT PLUS glucose analyzer using capillary plasma. Study results indicated that intended lay persons were able to obtain sufficiently accurate blood glucose readings when using the Sejoy Advance Link Blood Glucose Monitoring System compared to the laboratory-based comparator method. In addition, the participating lay persons were questioned and responded as satisfied with the ease of operation by following the Instructions for Use in the User Guide and the overall performance of the Sejoy Advance Link Blood Glucose Monitoring System. Users were able to achieve the following level of accuracy compared to the laboratory method:

| Within ±5% | Within ±10% | Within ±15% | Within ±20% |
|-------------------|-------------------|-------------------|------------------|
| n (%) | n (%) | n (%) | n (%) |
| $200/352 = 56.8%$ | $318/352 = 90.3%$ | $346/352 = 98.3%$ | $352/352 = 100%$ |

## Accuracy at extreme glucose concentrations

A study was conducted to assess the accuracy of Sejoy Advance Link Blood Glucose Monitoring System at extremely low and high glucose levels using contrived capillary blood specimens. Among them, 50 subjects had low blood glucose (<80 mg/dL), and 50 had high blood glucose (>250 mg/dL). All blood glucose samples were unaltered. All samples were tested with the Sejoy Advance Link Blood Glucose Monitoring System using 3 test strips lots and compared to the results obtained on the comparator method (YSI 2300). Results are summarized below:

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| Sejoy Advance Link Blood Glucose Monitoring System for glucose concentrations <80 mg/dL | | | |
|------------------------------------------------------------------------------------------|----------------|----------------|----------------|
| Within +/- 5% | Within +/- 10% | Within +/- 15% | Within +/- 20% |
| 27/50(54.0%) | 46/50(92.0%) | 50/50(100.0%) | 50/50(100.0%) |
| Sejoy Advance Link Blood Glucose Monitoring System for glucose concentrations >250 mg/dL | | | |
| Within +/- 5% | Within +/- 10% | Within +/- 15% | Within +/- 20% |
| 30/50(60.0%) | 48/50(96.0%) | 50/50(100.0%) | 50/50(100.0%) |

# 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 Sejoy Blood Glucose Monitoring Systemand and Sejoy Advance Link 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. Sejoy Blood Glucose Monitoring System and Sejoy Advance Link Blood Glucose Monitoring System also meets the recommendations of FDA Guidance: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use (September 2020), and applicable recognized electrical and safety standards including FCC requirements.

## Conclusions

The proposed device is substantially equivalent in its intended use, performance, safety, effectiveness and underlying scientific and operating principles to the predicate, The OneTouch Verio Reflect Blood Glucose Monitoring System (K193475).