BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System

K220421 · Apex BioTechnology Corp. · NBW · Nov 4, 2022 · Clinical Chemistry

Device Facts

• Record ID: K220421
• Device Name: BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Nov 4, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device system is intended for single-patient use only.

Device Story

BGM039 and BGM039 Link are blood glucose monitoring systems for home self-testing by patients with diabetes. Systems consist of a meter and single-use test strips. Input: fresh capillary whole blood sample applied to test strip. Operation: electrochemical measurement of glucose concentration; BGM039 Link includes Bluetooth module for wireless data transfer to mobile devices. Output: quantitative blood glucose level displayed on meter LCD. Healthcare providers use output to monitor diabetes control effectiveness. Benefits: enables patient self-monitoring of glucose levels to manage diabetes. BGM039 Link adds wireless connectivity; BGM039 is the base model without Bluetooth. Both models use the same test strips and core glucose measurement algorithm as the predicate.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence is supported by non-clinical bench testing, including robustness, drop, battery life, linearity, intermediate precision, within-run precision, accuracy, usability, EMC, electrical safety, and software verification/validation.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Electrochemical sensing principle. Uses single-use test strips. BGM039 Link includes Bluetooth module for wireless connectivity. Dimensions: 86Lx58Wx18H (mm). Software includes Bluetooth communication and error messaging (Err5-Err8).

Indications for Use

Indicated for single-patient use for blood glucose monitoring.

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

• GlucoSure HT Plus Blood Glucose Monitoring System (K202885)

Submission Summary (Full Text)

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November 4, 2022

Apex BioTechnology Corp. Lisa Liu Manager of Quality Assurance Division No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu. 30078 Taiwan

### Re: K220421

Trade/Device Name: BGM039 Blood Glucose Monitoring System BGM039 Link Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: July 20, 2022 Received: July 20, 2022

### Dear Lisa 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/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (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,

Digitally signed by Paula Paula Caposino -S Caposino -S Date: 2022.11.04
10:26:19 -04'00'

Paula V. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K220421

Device Name

BGM039 Blood Glucose Monitoring System

#### Indications for Use (Describe)

The BGM039 Blood Glucose Monitoring System is comprised of the BGM039 Blood Glucose Meter and the BGM039 Blood Glucose Test Strips.

The BGM039 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

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)

#### 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K220421

Device Name

BGM039 Link Blood Glucose Monitoring System

Indications for Use (Describe)

The BGM039 Link Blood Glucose Monitoring System is comprised of the BGM039 Link Blood Glucose Meter and the BGM039 Blood Glucose Test Strips.

The BGM039 Link Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearm, or palm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). It is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control and should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

### 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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# 510(k) Summary

| 510(k) number | K220421 |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Apex Biotechnology Corp. |
| | No. 7, Li-Hsin Road V, Hsinchu Science Park |
| | Hsinchu, 30078 |
| | CHINA (TAIWAN) |
| Contact Person | Lisa Liu |
| | Manager of Quality Assurance Division |
| | Apex Biotechnology Corp. |
| | No. 7, Li-Hsin Road V, Hsinchu Science Park |
| | Hsinchu, 30078 |
| | CHINA (TAIWAN) |
| | email: [e-mail] |
| | Phone: [phone] |
| | FAX: [phone] |
| Date Prepared | Feb 08, 2022 |
| Trade Names | BGM039 Blood Glucose Monitoring System |
| | BGM039 Link Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | NBW |
| Predicate Devices | GlucoSure HT Plus Blood Glucose Monitoring System (K202885) |
| Device | BGM039 brand of Blood Glucose Monitoring System is designed to have two |
| Description | variation models, BGM039 Blood Glucose Monitoring System and BGM039 |
| | Link Blood Glucose Monitoring System. BGM039 Blood Glucose Monitoring |
| | System is the models with all the changes implemented with exception to the |
| | addition of a Bluetooth module, whereas, BGM039 Link Blood Glucose |
| | Monitoring System is implemented with all of the changes stated in the |
| | submission. The two meters use the same BGM039 Test Strip and Contrex Plus |
| | 4 Control Solution. This Premarket Notification (510(k)) is intended to |
| | demonstrate that the candidate devices to be marketed is safe and effective as the |
| | predicate device, GlucoSure HT Plus Blood Glucose Monitoring System, |
| | K202885.…