SuperCheck Pro Blood Glucose Monitoring System

K213061 · Ok Biotech Co., Ltd. · NBW · Oct 7, 2022 · Clinical Chemistry

Device Facts

• Record ID: K213061
• Device Name: SuperCheck Pro Blood Glucose Monitoring System
• Applicant: Ok Biotech Co., Ltd.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SuperCheck Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, upper arm, calf, thigh, or palm. It is intended to be used by a single person and should not be shared. The SuperCheck Pro Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. The SuperCheck Pro Blood Glucose Monitoring System is not intended for the diagnosis of or diabetes mellitus, nor for use with neonates. Alternative site testing should be done only during steady-state conditions (when blood glucose is not changing rapidly).

Device Story

System measures glucose in capillary whole blood via amperometric technology. User inserts test strip into meter; applies blood drop to strip; meter detects electrical current generated by reaction between glucose and GDH-FAD enzyme on carbon-printed electrodes. Current strength is proportional to glucose concentration. Used at home by patients with diabetes for self-monitoring. Output displayed on meter; data transmitted via Bluetooth to mobile app. Helps patients monitor diabetes control program effectiveness. Includes control solution for system verification.

Clinical Evidence

User evaluation study conducted to confirm system accuracy, operation, and ease of use. Non-clinical testing included electrical/mechanical safety, precision, linearity, interference, and robustness studies. All performance criteria met.

Technological Characteristics

Amperometric glucose test system using GDH-FAD enzyme. Measuring range: 20-600 mg/dL. Sample volume: 0.5 μL. Operating conditions: 10-40°C, 10-85% RH. Hematocrit range: 20-60%. Connectivity: None (standalone). Calibration: Automatic. Sterilization: Not applicable (in vitro diagnostic).

Indications for Use

Indicated for people with diabetes mellitus for quantitative self-testing of glucose in fresh capillary whole blood (finger, forearm, upper arm, calf, thigh, or palm) as an aid in monitoring diabetes control. Not for diagnosis or screening of diabetes; not for use with neonates. Alternative site testing restricted to steady-state conditions.

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

• WowGoHealth Blood Glucose Monitoring System (k171785)

Submission Summary (Full Text)

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October 7, 2022

OK BioTech Co., Ltd. Laurie Liu Special Assistant to GM No. 91, Sec. 2, Gongdao 5th Rd. Hsinchu City, 30070, Taiwan

Re: K213061

Trade/Device Name: SuperCheck Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW Dated: July 6, 2022 Received: July 8, 2022

Dear Laurie Liu:

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/cfpmp/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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 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.

Paula Caposino, Ph.D. Acting Deputy Director 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) K213061

Device Name

SuperCheck Pro Blood Glucose Monitoring System

Indications for Use (Describe)

The SuperCheck Pro Blood Glucose Monitoring System is comprised of the SuperCheck Pro Blood Glucose Meter and SuperCheck Pro Blood Glucose Test Strips.

The SuperCheck Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, upper arm, calf, thigh, or palm. It is intended to be used by a single person and should not be shared. The SuperCheck Pro Blood Glucose Monitoring System is for self-testing outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.

The SuperCheck Pro Blood Glucose Monitoring System is not intended for the diagnosis of or diabetes mellitus, nor for use with neonates.

Alternative site testing should be done only during steady-state conditions (when blood glucose is not changing rapidly).

| 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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# 510(k) Summary

Submission Number: K213061

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

#### I. Submitter Information

| Company Name | OK Biotech Co., Ltd. |
|--------------------|------------------------------------------|
| Address | No. 91, Sec. 2, Gongdao 5th Rd., Hsinchu |
| | City 30070, Taiwan. |
| Telephone | [phone] |
| Fax | [phone] |
| Date of Submission | October 7, 2021 |
| Contact Person | Laurie Liu |
| Title | Special assistant to GM |
| E-mail | [e-mail] |

#### II. Regulatory information:

| Proprietary Name | SuperCheck Pro Blood Glucose Monitoring System |
|----------------------|--------------------------------------------------|
| Model No. | Meter: OK-2MJB, Strips: OK2M |
| Common Name | Blood Glucose Monitoring System |
| Regulation section | 21 CFR § 862.1345, Glucose Test System |
| Regulatory Class | Class II |
| Product Code | NBW, Blood glucose test system, over the counter |
| Classification Panel | Clinical Chemistry |

#### III. Predicate Device Information

| Manufacturer | Biotest Medical Corp. |
|---------------|---------------------------------------------|
| Device Name | WowGoHealth Blood Glucose Monitoring System |
| 510(k) Number | k171785 |

#### IV. Indications for Use

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Image /page/4/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized "K" with an orbital design around it, followed by the text "biotech" in a bold, sans-serif font. Below the company name is Chinese text, which likely represents the company's name in Chinese characters.

The SuperCheck Pro Blood Glucose Monitoring System is comprised of the SuperCheck Pro Blood Glucose Meter and SuperCheck Pro Blood Glucose Test Strips.

The SuperCheck Pro Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, forearm, upper arm, calf, thigh, or palm. It is intended to be used by a single person and should not be shared. The SuperCheck Pro Blood Glucose Monitoring System is for selftesting outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program.

The SuperCheck Pro Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, nor for use with neonates.

Alternative site testing should be done only during steady-state conditions (when blood glucose is not changing rapidly).

#### V. Device Description

SuperCheck Pro Blood Glucose Monitoring System is used for determining the approximate concentration of glucose in the blood. A complete kit (starter kit) of SuperCheck Pro Blood Glucose Monitoring System consists of:

- 1. SuperCheck Pro Blood Glucose Meter
- 2. SuperCheck Pro Blood Glucose Test Strips
- 3. OKmeter Control Solution (Level I, II)

Before use, The SuperCheck Pro Blood Glucose Test Strips should be inserted into the SuperCheck Pro Blood Glucose Meter first. Prick a fingertip with a sterile Lancet that installed in the Lancing device and apply the blood drop to the front edge of the Test Strip. Wait for 5 seconds and the Meter will display the test result.

OKmeter Control Solution containing a known amount of glucose that is used to confirm SuperCheck Pro Blood Glucose Meter and SuperCheck Pro Blood Glucose Test Strips are working properly together. Follow the same steps as above but replace the blood drop by OKmeter Control Solution.

OKmeter Control Solution and SuperCheck Pro Blood Glucose Test Strips could be separately bought.

#### Test Principle: VI.

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Image /page/5/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K with an orbital design around it, followed by the text "biotech" in a bold, sans-serif font. Below the company name is the company's name in Chinese characters.

The SuperCheck Pro Blood Glucose Monitoring System (Model OK-2MJB) measures the amounts of glucose in whole blood quantitative using fresh capillary whole blood from the fingertip and alternative sites including palm, forearm, upper arm, calf, and thigh. Amperometric technology is used for the detection of glucose from the strip with whole blood sample on the meter. Reagent consisting of glucose dehydrogenase with its cofactor flavin adenine dinucleotide (GDH-FAD) and mediator is deposited onto the reaction area of the test strip with carbon printed electrodes. The testing is based on the measurement of electrical current generated by the reaction of capillary whole blood glucose with the enzyme, GDH-FAD, on the test strip. The meter measures the strength of the current which is proportional to the amounts of glucose in the sample and displays the corresponding blood glucose concentration.

#### VII. Comparison of Technological Characteristics with the Predicate Device

SuperCheck Pro Blood Glucose Monitoring System shares either same or similar intended use, design, performance, and functions of the predicate devices and is therefore substantially equivalent to the predicated device.

| Comparison Items | New device | Predicate device (k171785) |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name of manufacturer | OK Biotech Co., Ltd. | Biotest Medical Corp. |
| Proprietary Name | SuperCheck Pro Blood<br>Glucose Monitoring System | WowGoHealth Blood Glucose<br>Monitoring System |
| Model No. | OK-2MJB | GSH-BGM902 |
| Product Code | NBW | NBW |
| Type of use | -Over-the-Counter | Over-the-Counter |
| Similarities | | |
| Intended Use | The SuperCheck Pro Blood<br>Glucose Monitoring System is<br>comprised of the SuperCheck<br>Pro Blood Glucose Meter and<br>SuperCheck Pro Blood<br>Glucose Test Strips.<br>The SuperCheck Pro Blood<br>Glucose Monitoring System is<br>intended for use in the<br>quantitative measurement of<br>glucose in fresh capillary<br>whole blood from the finger,<br>forearm, upper arm, calf, | The WowGoHealth Blood<br>Glucose Monitoring System<br>(Model GSH-BGM902) is<br>intended to be used for the<br>quantitative measurement of<br>glucose in fresh capillary<br>whole blood drawn from the<br>fingertips or forearm. The<br>WowGoHealth Blood Glucose<br>Monitoring System (Model<br>GSH-BGM902) is intended to<br>be used by a single person and<br>should not be shared.<br>The WowGoHealth Blood<br>Glucose Monitoring System |
| Comparison Items | New device | Predicate device (k171785) |
| | thigh, or palm. It is intended to<br>be used by a single person and<br>should not be shared. The<br>SuperCheck Pro Blood<br>Glucose Monitoring System is<br>for self-testing outside the<br>body (in vitro diagnostic use)<br>by people with diabetes<br>mellitus at home as an aid in<br>monitoring the effectiveness<br>of a diabetes control program.<br>The SuperCheck Pro Blood<br>Glucose Monitoring System is<br>not intended for the diagnosis<br>of or screening for diabetes<br>mellitus, nor for use with<br>neonates.<br>Alternative site testing should<br>be done only during steady-<br>state conditions (when blood<br>glucose is not changing<br>rapidly). | (Model GSH-BGM902) is<br>intended for self-testing<br>outside the body (in vitro<br>diagnostic use) by people with<br>diabetes at home as an aid in<br>monitoring the effectiveness<br>of a diabetes control program.<br>The WowGoHealth Blood<br>Glucose Monitoring System<br>(Model GSH-BGM902)<br>should not be used for the<br>diagnosis of or screening of<br>diabetes or for neonatal use.<br>Alternative site testing should<br>be done only during steady<br>state times (when glucose is<br>not changing rapidly). |
| Specimen Type | Capillary whole blood | Capillary whole blood |
| Detecting Range | 20~600 mg/dL (1.1~33.3<br>mmol/L) | 20~600 mg/dL (1.1~33.3<br>mmol/L) |
| Response Time | 5 seconds | 5 seconds |
| Power Requirements | Two 1.5V AAA alkaline<br>batteries | Two 1.5V AAA alkaline<br>batteries |
| Dimensions | 100 mm (L) x 50 mm (W) x<br>20 mm (H)<br>Approximate 69 g | 100 mm (L) x 50 mm (W) x<br>20 mm (H)<br>Approximate 69 g |
| Voice Function | No | No |
| Average calculation<br>(specify) | 7, 14, 28, 60 and 90 days | 7, 14, 28, 60 and 90 days |
| Insufficient Blood<br>Warning | Yes | Yes |
| Eject Button | Yes | Yes |
| Comparison Items | New device | Predicate device (k171785) |
| Enzyme | Flavin adenine dinucleotide-<br>glucose dehydrogenase (FAD-GDH) | Flavin adenine dinucleotide-<br>glucose dehydrogenase (FAD-GDH) |
| HCT Range | 20-60% | 20-60% |
| PC Link | No | No |
| Downloadable | Bluetooth | Bluetooth |
| Bluetooth data<br>transmission APP | WOWGOHEALTH APP | WOWGOHEALTH APP |
| Coding | No | No |
| Differences | | |
| Test Strips | SuperCheck Pro Blood<br>Glucose Test Strips | WowGoHealth Blood Glucose<br>Test Strip |
| Sample Volume | 0.5 μL | 1.1 μL |
| Alternate-Site Testing<br>(AST) | palm, forearm, upper arm,<br>calf, and thigh. | Forearm |
| Control Solution | OKmeter Control Solution | WowGoHealth Control<br>Solution |
| Operating Condition | 50~104°F (10~40°C),<br>10~85% RH<br>Altitude ≤ 11,161 ft (3,402 m) above the sea level | 50~104°F (10~40°C),<br>20~80% RH<br>Altitude ≤ 10,744 ft (3,275 m) above the sea level |
| Strips Storage<br>Conditions | 39~104°F (4~40°C) /<br>10~85% R.H. (strip included) | 35.6~86°F (2~30°C) /<br>20~80% R.H. (strip included) |
| Control Solution<br>Storage Conditions | 39~86°F (4~30°C )<br>(control solution included) | 35.6~86°F (2~30°C)<br>(control solution included) |
| Memory Storage | 1000 measurements with day<br>and time | 500 measurements with day<br>and time |
| Expiration for strip | Storage : 30 months<br>In-Use : 180 days | Storage : 5 months<br>In-Use : 3 months |
| Expiration for control<br>solution | Storage: 18 months<br>In-Use: 90 days | Storage: 24 months<br>In-Use: 3 months |

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#### Summary of Testing VIII.

Non-clinical and clinical studies were conducted to test, verify, and validate the performance of the proposed device according to FDA Guidance issued on September 29, 2020: Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use and other relevant standards. Results from these studies show that all performance criteria were met.

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Image /page/8/Picture/0 description: The image shows the logo for Kbiotech. The logo features a stylized letter K with three rings around it, followed by the word "biotech" in a bold, sans-serif font. Below the word "biotech" is the company's name in Chinese characters.

Non-Clinical Testing Summary: Design verification and validation testing was performed to ensure that the SuperCheck Pro Blood Glucose Monitoring System (Model OK-2MJB) met design specifications and requirements. Testing activities included electrical/mechanical safety tests, functional performance tests (precision, linearity, interference, flex studies) as well as disinfection, cleaning, and robustness studies. Software validation was performed for this moderate level of concern device per FDA Guidance Content of Premarket Submissions for Software Contained in Medical Devices.

Clinical Testing Summary: A user evaluation confirmed the system accuracy, operation according to design, and ease of use to support the intended use as described in the proposed labeling.

#### IX. Conclusion

Based on the information provided in this submission, it was concluded that the SuperCheck Pro Blood Glucose Monitoring System (Model OK-2MJB) is substantially equivalent to the predicate device.