Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus

K173638 · Bionime Corporation · NBW · Aug 17, 2018 · Clinical Chemistry

Device Facts

• Record ID: K173638
• Device Name: Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus
• Applicant: Bionime Corporation
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Rightest Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared. Rightest Blood Glucose Monitoring System Max 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Rightest Blood Glucose Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max. Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared. Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The Rightest Blood Glucose Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus. GE Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared. GE Blood Glucose Monitoring System Max 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max. GE Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared. GE Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). The GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.

Device Story

System measures glucose in fresh capillary whole blood via electrochemical sensor; requires 0.75 microliter sample. User applies blood to test strip inserted into meter; meter performs analysis and displays result on LCD. Used by patients with diabetes at home for self-monitoring. Max Plus model includes Bluetooth for data transmission. Output aids patients in assessing diabetes control effectiveness. Devices are handheld, battery-powered, and feature auto-coding.

Clinical Evidence

User performance study with 357 lay users comparing fingertip, palm, and forearm results against YSI 2300 laboratory reference. Accuracy results: 100% of fingertip and palm samples within ±20% of reference; 99.4% of forearm samples within ±20%. Analytical performance supported by precision, linearity, interference, and environmental robustness studies.

Technological Characteristics

Electrochemical sensor using FAD-glucose dehydrogenase. Measures glucose 10-600 mg/dL. Hematocrit range 10-70%. Sample volume 0.75 microliter. Test time 5 seconds. Powered by CR2032 batteries. Connectivity: Bluetooth (Max Plus models). Auto-coding. LCD display. Memory capacity 1000 results.

Indications for Use

Indicated for self-testing of blood glucose levels in people with diabetes to monitor glycemic control. Suitable for use with fresh capillary whole blood from fingertips, forearm, or palm. Contraindicated for neonatal use, diabetes diagnosis, or screening.

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

• Rightest Blood Glucose Monitoring System GM720 (K140210)

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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 17, 2018

Bionime Corporation % Feng-Yu Lee, Principal Consultant Dynamic Biotech Inc. dba IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675

Re: K173638

Trade/Device Name: Rightest Blood Glucose Monitoring System Max Rightest Blood Glucose Monitoring System Max Plus GE Blood Glucose Monitoring System Max GE Blood Glucose Monitoring System Max Plus Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: June 15, 2018 Received: July 20, 2018

Dear Feng-Yu Lee:

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.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Kellie B. Kelm -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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510(k) Number (if known) k173638

Device Name

Rightest Blood Glucose Monitoring System Max

#### Indications for Use (Describe)

Rightest Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Max 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |

|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

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510(k) Number (if known) k173638

Device Name

Rightest Blood Glucose Monitoring System Max Plus

#### Indications for Use (Describe)

Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NECESSARY

# 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

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510(k) Number (if known) k173638

Device Name GE Blood Glucose Monitoring System Max

### Indications for Use (Describe)

GE Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

GE Blood Glucose Monitoring System Max 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max.

| 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:

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

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510(k) Number (if known) k173638

Device Name

GE Blood Glucose Monitoring System Max Plus

#### Indications for Use (Describe)

GE Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

GE Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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

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# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: k173638

- Submitter's Identification: 1.
BIONIME CORPORRATION NO 100, Sec. 2, Daqing St., South Dist., 40242 Taichung City, Taiwan Contact Person: Roy Huang Phone Number: 886-4-23692388 FAX Number: 886-4-22617568

c/o IVDD Regulatory Consultant 29222 Rancho Viejo Road, Suite 218 San Juan Capistrano, CA 92675 Contact Person: Feng-Yu Lee Phone Number: 1-949-218-0929 Fax Number: 1-949-218-0928

Date Summary Prepared: August 15th, 2018

- 2. Name of the Device: Rightest Blood Glucose Monitoring System Max Rightest Blood Glucose Monitoring System Max Plus GE Blood Glucose Monitoring System Max GE Blood Glucose Monitoring System Max Plus
- 3. Common or Usual Name: Glucose test system

| Product Code | Classification | Regulation Section | Panel |
|-------------------------------------------------------|----------------|--------------------|--------------------------|
| NBW; System, Test, Blood<br>Glucose, Over-the-Counter | Class II | 21 CFR 862.1345 | Clinical Chemistry<br>75 |

- 4. Device Description:
For Over-the-Counter Setting:

Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus, consist of the following devices:

Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and

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Lancing Device are manufactured by BIONIME Corporation.

Rightest Meter Max and Rightest Meter Max Plus, when used with the Rightest Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of Rightest Blood Glucose Monitoring System Max and Rightest Blood Glucose Monitoring System Max Plus are verified by the Rightest Control Solution GC700.

GE Blood Glucose Monitoring System Max and GE Blood Glucose Monitoring System Max Plus, consist of the following devices:

Blood Glucose Meter, Blood Glucose Test Strip, Control Solution, lancing device and sterile lancets. The Blood Glucose Meter, Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation.

GE Meter Max and GE Meter Max Plus, when used with the GE Test Strips Max, quantitatively measure glucose in fresh whole blood samples from capillary. The performance of GE Blood glucose monitoring System Max and GE Blood glucose monitoring System Max Plus are verified by the Rightest Control Solution GC700.

#### Intended Use: న.

### Rightest Blood Glucose Monitoring System Max

Rightest Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Max 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Monitoring System Max is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max.

### Rightest Blood Glucose Monitoring System Max Plus

Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

Rightest Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

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The Rightest Blood Glucose Monitoring System Max Plus is comprised of the Rightest Blood Glucose Test Strip Max and the Rightest Meter Max Plus.

# GE Blood Glucose Monitoring System Max

GE Blood Glucose Monitoring System Max is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

GE Blood Glucose Monitoring System Max 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GE Blood Glucose Monitoring System Max is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max.

## GE Blood Glucose Monitoring System Max Plus

GE Blood Glucose Monitoring System Max Plus with Bluetooth function is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. It is intended to be used by a single person and should not be shared.

GE Blood Glucose Monitoring System Max Plus with Bluetooth function 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. It should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly).

The GE Blood Glucose Monitoring System Max Plus is comprised of the GE Blood Glucose Test Strip Max and the GE Meter Max Plus.

#### 6. Predicate Device Information:

Rightest and GE Blood Glucose Monitoring Systems Max and Max Plus are substantially equivalent to:

Rightest Blood Glucose Monitoring System GM720 Device Company: Bionime Corporation 510(K) Number: K140210

#### 7. Comparison to Predicate Devices:

| Models | Rightest BGMS<br>Max Plus<br>(New Device) | Rightest BGMS Max<br>(New Device) | Rightest BGMS GM720<br>(Predicate Device) |
|----------------------------------|-------------------------------------------|-----------------------------------|-------------------------------------------|
| GE BGMS Max Plus<br>(New Device) | GE BGMS Max<br>(New Device) | K140210 | |

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# Bionime Corporation

| Measurement<br>Technology | Dehydrogenase Electrochemical Sensor | |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Sample Type | Fresh capillary whole blood | |
| Alternative Sample<br>Site | The fingertips, palm, forearm. | |
| minimum sample<br>volume | 0.75 microliter | |
| Test Time | 5 seconds | |
| Control Solution | 3 levels (Level 1, 2, and 4)<br>Rightest Control Solution GC700 | |
| Operating<br>Conditions | Temperature 43 ~111 °F (6 ~ 44°C), 10 ~ 90% Relative Humidity | |
| Meter Storage<br>Conditions | 14~140 °F (-10~60℃) | |
| Test Strip Shelf<br>Life (After<br>Opening) | 4 months | |
| Hematocrit Range | 10 - 70 % | 20 - 65% |
| Measuring Range | 10-600 mg/dL | 20-600 mg/dL |
| Test Strip Reagent | 1. FAD-Glucose dehydrogenase 12.4 %<br>2. Potassium Ferricyanide 49.6 %<br>3. Non-reactive Ingredients 38.0 % | 1. FAD-Glucose<br>dehydrogenase 12.1%<br>2. Potassium ferricyanide<br>48.5%<br>3. Non-reactive<br>ingredients 39.4% |
| Interference | Dopamine HCl > 2.3 mg/dL<br>Gentisic Acid > 3.0 mg/dL<br>Glutathione reduced > 35 mg/dL<br>Hemoglobin > 10,000 mg/dL<br>Uric Acid > 10 mg/dL<br>Maltose > 1900 mg/dL<br>Xylose > 9.0 mg/dL | Ascorbic acid > 3 mg/dL;<br>Glutathione reduced >60<br>mg/dL; Uric Acid > 12<br>mg/dL |
| Power Saving | Turn off automatically 2 minutes after last user action / Press the main button for<br>3 seconds. | |
| Coding | Auto coding | |
| Monitor | LCD display | |

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# Bionime Corporation

| Models | Rightest BGMS<br>Max Plus<br>(New Device) | Rightest BGMS Max<br>(New Device) | Rightest BGMS GM720<br>(Predicate Device) |
|------------------|----------------------------------------------------|----------------------------------------------------|----------------------------------------------------|
| | GE BGMS Max Plus<br>(New Device) | GE BGMS Max<br>(New Device) | K140210 |
| Backlight | | Yes | |
| Color | | black | |
| Memory Capacity | 1000 blood glucose test results with date and time | 1000 blood glucose test results with date and time | 1000 blood glucose test results with date and time |
| Power Supply | Two CR2032 batteries | One CR2032 battery | Two CR2032 batteries |
| Wireless module | Yes | | No |
| Battery Life | 1000 Tests | 1000 Tests | 600 Tests |
| Meter Dimension | 50.0 mm x 82.0 mm x 15.5 mm | 50.0 mm x 82.0 mm x 15.5 mm | 71.5 mm x 39.5 mm<br>x14.0 mm |
| LCD display area | 40.7 mm x 40.2 mm | 40.7 mm x 40.2 mm | 25.02 mm x 32.7 mm |
| Meter Weight | 59 ± 5g with batteries | 59 ± 5g with batteries | 50 ± 5 g with batteries |

#### 8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of Rightest Blood Glucose Monitoring System Max Plus. The evaluation included precision, linearity, interference, sample volume and hematocrit.

#### 9. Discussion of Clinical Tests Performed:

# Layuser Performance Study:

A User performance study with 357 participants was performed to demonstrate that lay users could obtain accurate results using the subject device. The study was performed using capillary whole blood from fingertip, palm and forearm sample sites. The study result shows substantial equivalence to comparison method.

#### 10. Conclusions:

Results of performance evaluation of Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood glucose monitoring System Max and GE Blood glucose monitoring System Max Plus demonstrate that the candidate devises are substantial equivalence to the predicate device, Rightest Blood Glucose Monitoring System GM720.