BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System

K161299 · Apex BioTechnology Corp. · NBW · Dec 23, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161299
• Device Name: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Dec 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

BGM014 System: The BGM014 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). Testing is done outside the body (In Vitro diagnostic use). It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip. The Contrex Plus 5 glucose control solution is used with the BGM014 Meter and BGM014 Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly. BGM014 Pro System: The BGM014 Pro Blood Glucose Monitoring System is intended for quantitatively measurement of glucose in venous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare settings as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use. The BGM014 Pro Blood Glucose Monitoring System is comprised of the BGM014 Pro Blood Glucose Meter and BGM014 Pro Test Strip. The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Meter and BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.

Device Story

Electrochemical biosensor system; measures glucose in capillary or venous blood; uses glucose dehydrogenase (FAD-GDH) enzyme and redox mediator on disposable test strips; handheld meter converts generated current to glucose concentration; proportional relationship between current and glucose; BGM014 for home use (single patient); BGM014 Pro for professional use (multiple patients); includes data port for management software; provides quantitative results to aid diabetes control; requires auto-disabling lancing devices for professional use; validated for cleaning/disinfection robustness.

Clinical Evidence

Bench testing only. Precision studies (n=600 per level), linearity (20-600 mg/dL), interference testing, and user performance studies (n=137 lay users) comparing device results to YSI 2300 reference method. Accuracy met requirements for fingertip, palm, and forearm samples.

Technological Characteristics

Glucose test system; electrochemical sensing principle. Includes meter and test strips. Pro model features disinfection-resistant housing for multi-patient use. Software verification/validation performed. No specific materials or algorithm architecture details provided.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, palm, forearm) for home self-testing (BGM014) or venous/capillary whole blood for professional use (BGM014 Pro). Not for diabetes diagnosis/screening or neonatal use.

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

• AutoSure HT Blood Glucose Monitoring System (k131750)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

December 23, 2016

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE MANAGER OF QUALITY ASSURANCE DEPARTMENT NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK HSINCHU 30078, TAIWAN

Re: K161299

Trade/Device Name: BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR, JJX Dated: November 30, 2016 Received: December 5, 2016

Dear Hsue-Mei 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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) k161299

Device Name BGM014 Blood Glucose Monitoring System

## Indications for Use (Describe)

The BGM014 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. Alterative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitto diagnostic use), It is intended for self-testing by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It should only be used by a single patient and it should not be shared. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The BGM014 Blood Glucose Monitoring System is comprised of the BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip.

The Contrex Plus 5 glucose control solution is used with the BGM014 Test Strip to verify that the meter and test strip are working together properly and that the test is performing correctly.

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) k161299

Device Name

BGM014 Pro Blood Glucose Monitoring System

#### Indications for Use (Describe)

The BGM014 Pro Blood Glucose Monitoring System is intended for the quantitatively measurement of glucose in yenous whole blood, or capillary whole blood drawn from fingertips, palm, or forearm. Alternative site testing should be performed only during steady-state (when glucose is not changing rapidly). Testing is done outside the body (In Vitro diagnostic use). It is intended for multiple-patient use in professional healthcare setting as an aid to monitor effectiveness of diabetes control program. This system should only be used with single use, auto-disabling lancing devices. It is not indicated for the diagnosis of or screening for diabetes or for neonatal use.

The BGM014 Pro Blood Glucose Monitoring System is comprised of the BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test Strip.

The Contrex Plus 5 glucose control solution is used with the BGM014 Pro Test Strip, to verify that the meter and test strip are working together properly and that the test is performing correctly.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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 [e-mail]

"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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### 9 510(k) Summary

| Submitter: | Apex Biotechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078<br>CHINA (TAIWAN) |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Hsue-mei Lee<br>Manager of Quality Assurance Department<br>Apex Biotechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078<br>CHINA (TAIWAN)<br><br>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared: | Dec 19, 2016 |
| Trade Names: | BGM014 Blood Glucose Monitoring System<br>BGM014 Pro Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II<br>Single (specified) analyte controls (assayed and unassayed), Class I, 21<br>CFR 862.1660 |
| Product Codes: | NBW, LFR, JJX |
| Predicate Devices: | AutoSure HT Blood Glucose Monitoring System (k131750) |
| Device Description: | The BGM014 blood glucose meter and BGM014 test strips are used for<br>self-testing of blood glucose. The BGM014 Pro blood glucose meter and<br>BGM014 Pro test strips are used for professional testing of blood<br>glucose. |
| Intended Use: | BGM014 System: The BGM014 Blood Glucose Monitoring System is<br>intended for the quantitative measurement of glucose in fresh capillary whole<br>blood samples drawn from the fingertips, forearm, or palm. Alternative site<br>testing should be performed only during steady-state (when glucose is not<br>changing rapidly). Testing is done outside the body (In Vitro diagnostic<br>use). It is intended for self-testing by people with diabetes at home as an aid<br>to monitor the effectiveness of diabetes control. It should only be used by a<br>single patient and it should not be shared. It is not indicated for the diagnosis<br>of or screening for diabetes or for neonatal use. |
| | The BGM014 Blood Glucose Monitoring System is comprised of the<br>BGM014 Blood Glucose Meter and BGM014 Blood Glucose Test Strip. |
| | The Contrex Plus 5 glucose control solution is used with the BGM014 Meter<br>and BGM014 Test Strip, to verify that the meter and test strip are working<br>together properly and that the test is performing correctly. |
| Intended Use: | BGM014 Pro System: The BGM014 Pro Blood Glucose Monitoring System<br>is intended for quantitatively measurement of glucose in venous whole<br>blood, or capillary whole blood drawn from fingertips, palm, or forearm.<br>Alternative site testing should be performed only during steady-state (when<br>glucose is not changing rapidly). Testing is done outside the body (In Vitro<br>diagnostic use). It is intended for multiple-patient use in professional<br>healthcare settings as an aid to monitor effectiveness of diabetes control<br>program. This system should only be used with single use, auto-disabling<br>lancing devices. It is not indicated for the diagnosis of or screening for<br>diabetes or for neonatal use. |
| | The BGM014 Pro Blood Glucose Monitoring System is comprised of the<br>BGM014 Pro Blood Glucose Meter and BGM014 Pro Blood Glucose Test<br>Strip. |
| | The Contrex Plus 5 glucose control solution is used with the BGM014 Pro<br>Meter and BGM014 Pro Test Strip, to verify that the meter and test strip are<br>working together properly and that the test is performing correctly. |

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510(k) Summary (Continued)

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510(k) Summary (Continued)

| Non-Clinical<br>Testing: | Testing was conducted as follows: EMC and Electrical Safety, disinfection<br>performance (robustness of meter to multiple cleanings and disinfections),<br>software verification and validation, linearity testing with validation of Lo/Hi<br>detection, temperature and humidity testing, sample volume verification,<br>precision testing, interferences testing, altitude testing, qualification of<br>control solutions, hematocrit performance testing, Results demonstrate<br>substantial equivalence to the predicate system. |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Testing | An accuracy study was conducted with home users and professional users<br>using finger, palm and forearm capillary whole blood. Venous blood testing<br>was also done by the professional users. Results demonstrate substantial<br>equivalence to the predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the BGM014 and<br>BGM014 Pro systems perform in a substantially equivalent manner to that of<br>the predicate. We conclude that the BGM014 and BGM014 Pro systems are<br>substantially equivalent to the predicate system. |