BGM009 BLOOD GLUCOSE MONITORING SYSTEM

K141036 · Apex BioTechnology Corp. · NBW · May 1, 2015 · Clinical Chemistry

Device Facts

• Record ID: K141036
• Device Name: BGM009 BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The BGM009 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). The device includes speaking functions but is not intended for use in visually impaired users. 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. The BGM009 Blood Glucose Test Strips are to be used with the BGM009 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Device Story

BGM009 Blood Glucose Monitoring System measures glucose in capillary whole blood via test strips. User applies blood sample to strip; meter performs electrochemical analysis; displays glucose concentration. Includes speaking functions; intended for home use by single patient. Modifications from predicate include hematocrit compensation feature, updated test strip holder, and modified electrode tracks on strips to support 6 calibration codes. Healthcare providers use results to monitor diabetes control effectiveness. Benefits include convenient, quantitative glucose monitoring for patients.

Clinical Evidence

Clinical accuracy evaluated in 143 lay users comparing BGM009 results to YSI 2300 reference method across fingertip, palm, and forearm sites. Glucose range 65-473 mg/dL. Results showed high concordance with reference method; >98% of results within ±15% of YSI for concentrations ≥75 mg/dL and 100% within ±20 mg/dL for all sites. Bench testing confirmed precision (CV 0.6-6.2%), linearity (20-600 mg/dL), and hematocrit compensation (20-60%).

Technological Characteristics

Electrochemical glucose test system. Features hematocrit compensation, 6 calibration codes, and speaking functions. Meter includes test strip holder; strips utilize modified electrode tracks. Software augmented for hematocrit compensation.

Indications for Use

Indicated for people with diabetes for self-monitoring of blood glucose levels using fresh capillary whole blood from fingertips, palm, or forearm. Not for neonatal use, diabetes screening, or diagnosis. Contraindicated for critically ill patients, severely hypotensive individuals, patients in shock, or those with severe dehydration.

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 Voice II Plus Blood Glucose Monitoring System (k113208)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with three curved lines above them.

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

2015 May 1,

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

Re: K141036

Trade/Device Name: BGM009 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: April 22, 2015 Received: April 23, 2015

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/Resourcesfor You/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.

# Courtney H Lias -S

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) k141036

Device Name BGM009 Blood Glucose Monitoring System

#### Indications for Use (Describe)

The BGM009 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). The device includes speaking functions but is not intended for use in visually impaired users. 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.

The BGM009 Blood Glucose Test Strips are to be used with the BGM009 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

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)

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## 510(k) Summary

| Submitter: | Apex Biotechnology Corp. |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | No. 7, Li-Hsin Road V, Hsinchu Science Park |
| | Hsinchu, 30078 |
| | CHINA (TAIWAN) |
| Contact Person: | Hsue-mei Lee |
| | Manager of Quality Assurance Department |
| | 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: | Septebmer 10, 2014 |
| Trade Names: | BGM009 Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW |
| Predicate Devices: | AutoSure Voice II Plus Blood Glucose Monitoring System (k113208) |
| Device Description: | The BGM009 blood glucose meter and BGM009 test strips are used for |
| | testing of blood glucose. |
| Intended Use: | The BGM009 Blood Glucose Monitoring System is intended for the<br>quantitative measurement of glucose in fresh capillary whole blood samples<br>drawn from the fingertips, forearm, or palm. Alternative site testing should be<br>performed only during steady-state (when glucose is not changing rapidly).<br>The device includes speaking functions but is not intended for use in visually<br>impaired users. It is intended for self testing outside the body (in vitro<br>diagnostic use) by people with diabetes at home as an aid in monitoring the<br>effectiveness of diabetes control and should only be used by a single patient<br>and it should not be shared. It is not indicated for the diagnosis or screening<br>of diabetes or for neonatal use.<br><br>The BGM009 Blood Glucose Test Strips are to be used with the BGM009<br>Blood Glucose Meter to quantitatively measure glucose in capillary whole<br>blood taken from fingertips, palm, or forearm. |
| Comparison of<br>Technological<br>Characteristics: | The BGM009 meter has been modified relative to the predicate by minor<br>changes in external design and modifications of the test strip holder to<br>support the hematocrit compensation feature. Meter software has been<br>augmented to support the hematocrit compensation feature. The BGM009<br>test strip has been modified relative to the predicate by minor changes in<br>chemistry, alteration of electrode tracks to support 6 calibration codes, and<br>addition of electrode tracks to support the hematocrit compensation feature. |
| Non-Clinical<br>Testing: | Testing was conducted as follows: EMC and Electrical Safety, test strip<br>holder reliability testing, battery life verification, drop testing, disinfection<br>performance (robustness of meter to multiple cleanings and disinfections),<br>software verification and validation, and linearity testing with validation of<br>Lo/Hi detection, temperature and humidity testing, sample volume<br>verification, precision testing, interferences testing, altitude testing,<br>qualification of control solutions, hematocrit performance testing,<br>disinfection testing with recommended disinfectant wipes was done using an<br>animal virus test model. Results demonstrate substantial equivalence to the<br>predicate system. |
| Clinical Testing | An accuracy study was conducted with home users, including evaluation of<br>ease of use and ease of understanding of the user manual. Results<br>demonstrate substantial equivalence to the predicate system. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the BGM009 system<br>performs in a substantially equivalent manner to that of the predicate. We |
| , conclude that the BGM009 system is substantially equivalent to the predicate ' | |
| ' system. | |

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### 510(k) Summary (Continued)

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