EASYMAX Tag Self-Monitoring Blood Glucose System

K201258 · Eps Bio Technology Corp. · NBW · Sep 1, 2021 · Clinical Chemistry

Device Facts

• Record ID: K201258
• Device Name: EASYMAX Tag Self-Monitoring Blood Glucose System
• Applicant: Eps Bio Technology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Sep 1, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EASYMAX® Tag Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

Device Story

Self-monitoring blood glucose system; measures glucose in capillary whole blood via test strips; intended for home use by patients with diabetes. Device consists of handheld meter; utilizes electrochemical biosensor technology. Modifications include: name change, physical redesign (rectangular shape, white color, two-button interface, bottom-loading strip port), power source change (CR2032 battery), increased memory (880 results), and addition of NFC connectivity. New features include automatic control solution identification, user-settable hypo/hyperglycemia indicators, meal-time tagging, and multi-day averaging. Patient applies blood sample to strip; meter processes signal; displays glucose concentration. Data aids patient in diabetes management. System supports single-patient use; validated for cleaning/disinfection with PDI SANI-CLOTH wipes.

Clinical Evidence

Bench testing only. Verification and validation activities were performed to assess the impact of hardware and firmware modifications. Design outputs met pre-determined design inputs, and risk mitigation was verified according to ISO 14971:2007 standards.

Technological Characteristics

Electrochemical glucose biosensor. Power: 1x CR2032 lithium battery. Connectivity: NFC. Form factor: 74 x 47 x 12.4 mm, 26g. Memory: 880 results. Features: automatic control solution identification, meal tagging, hypo/hyperglycemia indicators, 7/14/30/90 day averaging. Single-patient use; validated for chemical disinfection.

Indications for Use

Indicated for single-patient home use (OTC) by individuals with diabetes to monitor blood glucose effectiveness. Not for neonates, diagnosis, or screening. Use only with fresh capillary whole blood (fingertip, palm, forearm).

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

• EasyMax MU Self-Monitoring Blood Glucose System (K121207)

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.

September 1, 2021

EPS Bio Technology Corp. Steve Tseng OA Manager No. 8 R&D RD.III Hsinchu Science Park Hsinchu City, 30077 Taiwan

Re: K201258

Trade/Device Name: EASYMAX Tag Self-Monitoring Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: January 20, 2021 Received: January 22, 2021

Dear Steve Tseng:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Kellie B. Kelm, Ph.D. 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) K201258

### Device Name

EASYMAX® Tag Self-Monitoring Blood Glucose System

### Indications for Use (Describe)

The EASYMAX® Tag Self-Monitoring Blood Glucose System is comprised of the EASYMAX® Tag meter and the EASYMAX® Tag test strips. The kit is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

| 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 contains the logo for EPS BIO TECHNOLOGY CORP. The logo consists of the letters "EPS" in a stylized, blue font on the left side of the image. To the right of the logo is the company name, "EPS BIO TECHNOLOGY CORP.", in a bold, black font. The text is aligned horizontally.

# 510(k) Summary of EASYMAX® Tag Self-Monitoring Blood Glucose System (As required by 21 CFR 807.92)

| Type of 510(k): | Special 510(k) |
|-----------------------|-----------------------------------------------------------------------------|
| 510(k) Number: | K201258 |
| Submitter Information | |
| Company Name: | EPS Bio Technology Corp. |
| Address: | No. 8, R&D Rd.III Hsinchu Science Park, Hsinchu city 30076<br>Taiwan, R.O.C |
| Phone: | [phone]#601 |
| Fax: | [phone] |
| Contact Person: | Steve Tseng |
| E-mail: | [e-mail] |

# Device Name

| Proprietary Name: | EASYMAX® Tag Self-Monitoring Blood Glucose System |
|----------------------|---------------------------------------------------|
| Common Name: | Blood Glucose Test System |
| Product Code: | NBW |
| Classification Name: | Blood Glucose Test System, Over-the Counter |
| Classification: | Class II |
| Regulation Number: | 21 CFR 862.1345 |

# Predicate Device

| Proprietary Name: | EasyMax MU Self-Monitoring Blood Glucose System |
|-------------------|-------------------------------------------------|
| 510(k) Number: | K121207 |

# Device Description

The modified device of EASYMAX® Tag (EM Tag) self-monitoring blood glucose system is derived from the existing device of EasyMax MU glucose meter and the modified device contain

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the NFC (Near-field communication) function to transfer glucose results to the mobile app. The self-monitoring blood glucose system consists of a blood glucose meter and test strips which are designed, tested, and verified to work together as a system to produce accurate blood glucose test results. The electrochemical principle on the test strip is the reaction of FAD glucose dehydrogenase (FAD-GDH) with blood glucose and a small electrical current generated proportional to the glucose concentration in the blood sample. The meter measures the current and displays the blood glucose result.

# Intended Use/Indications for Use:

#### A Intended Use(s):

See Indications for Use below.

#### B Indication(s) for Use:

The system consists of the EASYMAX® Tag meter and the EASYMAX® Tag test strips. The EASYMAX® Tag meter only is used with the EASYMAX® Tag test strips to quantitatively measure glucose in fresh capillary whole blood from fingertip, palm, or forearm. The EASYMAX® Tag Self-Monitoring Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertip, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by a single patient with diabetes and should not be shared, as an aid to monitor the effectiveness of diabetes control. The system is not to be used on neonates, nor for the diagnosis of, or screening for diabetes mellitus. Alternative site testing can be only used during steady-state blood glucose conditions.

#### Special Conditions for Use Statement(s): C

- OTC Over The Counter
- For in vitro diagnostic use

- The EASYMAX® Tag Self-Monitoring Blood Glucose System is intended to be used by a single patient and should not be shared.

- The system is not to be used on neonates, nor for the diagnosis of, or screening for

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diabetes mellitus.

- Should not be used at altitude above 10,000 feet as there may be an inaccurate test results.

- A hematocrit (percentage of your blood that is red blood cells) that is either higher than 60% or lower than 20% can cause inaccurate results.

- Use of this device on multiple patients may cause the potential risk to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.

#### D Special Instrument Requirements:

EASYMAX® Tag Blood Glucose Meter

# Comparison to the Predicate

| Similarities | | |
|--------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Item | Predicate Device | Modified Device |
| Name | EasyMax MU<br>K121207 | EASYMAX® Tag<br>K201258 |
| Intended use | EasyMax MU Self-Monitoring<br>Blood Glucose System is intended<br>for the quantitative measurement of<br>glucose in fresh capillary whole<br>blood from fingertip, palm, or<br>forearm. Testing is done outside the<br>body (In Vitro diagnostic use). It is<br>indicated for use at home (over the<br>counter [OTC]) by a single patient<br>with diabetes and should not be<br>shared, as an aid to monitor the<br>effectiveness of diabetes control.<br>The system is not to be used on<br>neonates, nor for the diagnosis of,<br>or screening for diabetes mellitus.<br>Alternative site testing can be only<br>used during steady-state blood<br>glucose conditions. | Same as predicate |
| Sample type | Fresh capillary whole blood | Same as predicate |

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Image /page/6/Picture/0 description: The image shows the logo for EPS, which is a company that specializes in providing solutions for the energy industry. The logo is a stylized version of the letters "EPS" in blue. The letters are connected to each other, and the logo has a modern and clean look. The logo is simple and memorable, and it effectively communicates the company's brand identity.

| Sample site | Finger, palm or forearm. | Same as predicate |
|-------------------------------------------|----------------------------------------|-------------------|
| Sample Volume | 0.6 uL | Same as predicate |
| Reaction Time | 5 seconds | Same as predicate |
| Measuring Range | 20-600 mg/dL | Same as predicate |
| Hematocrit (HCT) Range | 20-60% | Same as predicate |
| Operating condition | 50-104°F(10-40°C)<br><90 % RH | Same as predicate |
| Storage Condition | 38-86°F(2-30°C)<br>40-85% RH | Same as predicate |
| Detection method | Electrochemical biosensor<br>technique | Same as predicate |
| Enzyme | FAD glucose dehydrogenase | Same as predicate |
| Mediator | Potassium Ferricyanide | Same as predicate |
| Pin assignment of Test<br>strip electrode | Image: Barcode | Same as predicate |
| Coding | No code | Same as predicate |
| Measurement Unit | mg/dL | Same as predicate |
| Meter Case material | Polycarbonate (PC) | Same as predicate |
| Meter Case Texture | Non-Textured Surface | Same as predicate |

| Differences | | |
|--------------------|-----------------------------|-----------------------------|
| Item | Predicate Device | Modified Device |
| Power Supply | 1.5V AAA *2 | CR2032 * 1 |
| Battery Life | Over 2000 tests | Around 1000 times |
| Meter shape | oval shape | rectangle shape |
| Meter color | Black | White |
| Button | 3 buttons | 2 buttons |
| Meter Dimension | 94(L) x 50 (W) x 19.5(T) mm | 74(L) × 47(W) × 12.4 (T) mm |
| Weight w/o battery | 39 grams | 26 grams |
| LCD Dimension | 45.0 x 36.0 mm | 28(L) × 29(W)mm |

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Image /page/7/Picture/0 description: The image shows the logo for EPS in blue. The logo is a stylized version of the letters "EPS" with a modern and geometric design. The letters are bold and connected, giving the logo a sense of unity and strength. The color blue is often associated with trust, reliability, and professionalism, which may be the intended message of the logo.

| Display icons | | |
|--------------------------|----------------------------------------|--------------------------------------------------------------------------------------|
| Strip Insert location | Upper meter | Lower meter |
| Strip Ejector | Yes | No |
| Memory sets | 480 test results | 880 test results |
| Memory mode | N/A | Average on 7/14/30/90 days |
| Measurement Mode | Test Mode and Control Solution<br>Mode | Test Mode (before meal, after<br>meal) and Control Solution<br>Auto Measurement Mode |
| High/ Low Limit Function | N/A | High/ Low Setting and Glucose<br>level indication |
| Data Transfer | N/A | NFC |

In comparison with the predicate device, the modifications of the proposed device are as below:

- 1. Change the product name.
- 2. Hardware changes for power supply and also for battery life.
- 3. Meter outlook change with shape, color, buttons, dimension, weight, LCD dimension, display icon, insert location of test strip and strip ejector.
- 4. Software(firmware) changes with meter functions for display icons, buttons, memory mode, Test Mode (before meal, after meal), Control Solution Auto Measurement Mode and High/ Low Limit function.
- 5. Addition of the NFC function (hardware and firmware changes): wireless data transfers to a mobile device and the meter can communicate with a mobile by EzGluco TAG App.

Other than the above modification, the following remains the same to the predicate device:

- -Has the same intended use
- -Uses the same operating principle
- Uses the same glucose test strips -

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Due to the addition of wireless data transfer function, cybersecurity also becomes a necessary item for risk control. There is a risk analysis of software (firmware) about the data transmission list in risk management report. And, another summary plan & report about the intra-structure control can confirm this cybersecurity issue.

# Summary of Design Control Activities

Based on the modifications, the risk analysis was assessed and the risks were identified and controlled with verifications and validation activities which mitigated the risk index to acceptability. The risk analysis and design control activities were summarized below:

# Risk Analysis

The risk analysis was conducted according to ISO 14971:2007 standard. A Failure Modes and Effects Analysis (FMEA) was assessed to identify potential hazard and unaccepted risks for each modification. The control measures were to mitigate these risks to acceptable level with the implemented verification and validation activities. The complete analysis was in EASYMAX® Tag SMBGS risk management report in this submission.

# Verification and Validation activities

The verification and validate (V&V) activities were conducted based on the impact of the modification and detailed in the EASYMAX® Tag SMBGS risk management report. The similar V&V testing with similar acceptance criteria as the predicate was performed and the design outputs met pre-determined design inputs was confirmed in the software validation report in this submission.

# Conclusion

The modified device, EASYMAX® Tag SMBGS, has the same intended use and fundamental scientific technology as the predicate, EasyMax MU SMBGS which received 510 (k) clearance K121207.

After conducting risk analysis and design control activities, the modified device is substantially equivalent to the predicate device.