Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips

K150396 · Apex BioTechnology Corp. · NBW · Oct 14, 2015 · Clinical Chemistry

Device Facts

• Record ID: K150396
• Device Name: Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 14, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AutoSure Voice II Pro 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. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use. The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice II Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Device Story

The AutoSure Voice II and AutoSure Voice II Pro are blood glucose monitoring systems. The device measures glucose levels in capillary whole blood samples. The system provides audible and visual results to assist users in managing diabetes. The modification involves updating the trade names and adding validated cleaning and disinfection instructions for both self-testing and multiple-patient use environments. The device is used by patients for self-testing or by healthcare professionals in clinical settings. The output is a blood glucose concentration value, which informs clinical decision-making regarding insulin dosing or dietary adjustments. The device materials were tested for robustness against specific EPA-registered disinfectant wipes to ensure performance is maintained over the device's intended lifespan.

Clinical Evidence

No clinical testing was conducted. Substantial equivalence supported by non-clinical bench testing, specifically disinfection/viral inactivation and robustness testing.

Technological Characteristics

Glucose test system; electrochemical sensing principle. Includes voice functionality. Supports capillary whole blood testing. Identical to predicate except for updated disinfection protocols.

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood from the finger, palm, or forearm for self-testing by people with diabetes or for multiple-patient use in professional healthcare settings to monitor glucose levels.

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 Blood Glucose Monitoring System and AutoSure Blood Glucose Test Strips (k102037)

Submission Summary (Full Text)

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

October 14, 2015

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

Re: K150396

Trade/Device Name: AutoSure Voice II Blood Glucose Monitoring System AutoSure Voice II Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, CGA Dated: September 11, 2015 Received: September 14, 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

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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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,

Katherine Serrano -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 FREALTH AND HUMMA SERVICES<br>Indications for Use<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>See PRA Statement below.<br>xpiration Date: January 31, 2017 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known<br>R150396 | | |
| AutoSure Voice II Blood Glucose Monitoring Systen<br>Device Name | | |
| Indications for Use (Describe | | |
| changing rapidy). It is not intended for the disensis or screening of disbetes or for neonatal use<br>assets and forme as an is to moring blood glucoses nellifits. This system is for single-paties inst<br>to assist visually impared users. It is intended for self-testing outside the by beadly with<br>The AutoSure Voice II Blood Glucose Monitoring System is intended for the quartifative measurement of glucose in | | only and should not be shared. Alternative site testing should be done only during steady-state times (when glucose is not<br>fresh cary whole blood samples drawn the fingerting, forsearm, or palm. The more includes voice finestonality |
| messure glucose in capillary whole blood taken from fingertips, palm, or forcarm | | The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II Blood Glucose Meter to quantititively |
| | | |
| Type of Use (Select one or both, as applicable) | I Prescription Use (Part 21 CFF 801 Subpart D | X Over-The-Counter Use (21 CFR 801 Suppart C |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED | |
| | in setting so not of the Personice of the Pages work Peduction Act of the | |
| | of this information collection, including suggestions for reducing this purden, to:<br>WO WANT A SERIE YOUR CONTENT FOR THE PROFILE ADDRESS BELLO | time to reviews instructions, sestime data sources, gather and manufacturer in the<br>and review the collection of information. Send comments regarding of any other aspect<br>de on the senod served subor en established in the series and the mit not not not not not not only of the |
| | [e-mail]<br>Paperwork Reduction Act (PRA) State<br>Office of Chief Information Officer<br>Food and Drug Administration<br>Department of Health and Human Services | |
| | "," be genery my no conduct or sponsor, and a person is not respond to, a collection of<br>information unless it displays a currently valid OMB number." | |
| FOR FOR FOR 3888 (8114 | Page 1 of 1 | PSC Publishing Services [phone]<br>ਜਤੀ ਹੈ |

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

**Indications for Use**

| 510(k) Number (if known) | k150396 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | AutoSure Voice II Pro Blood Glucose Monitoring System |
| Indications for Use (Describe) | The AutoSure Voice II Pro 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. The meter includes voice functionality to assist visually impaired users. It is intended for multiple-patient use in professional healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus. This system should only be used with single-use auto-disabling lancing devices. Alternative site testing should be done only during steady-state times (when glucose is not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for neonatal use.<br>The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice II Pro 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) | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div> <input checked="true" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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The burden time for this collection of information is estimated to average 79 hours per response, including the
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and review the collection of information. Send comments regarding this burden estimate or any other aspect
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FORM FDA 3881 (8/14)

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## 510(k) Summary

| Submitter | Hsue-mei Lee<br>Manager of Quality Assurance Department<br>Apex BioTechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park, Hsinchu, 30078,<br>CHINA (TAIWAN)<br>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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, Hsinchu, 30078,<br>CHINA (TAIWAN)<br>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared | October 12, 2015 |
| Trade Names | AutoSure Voice II Blood Glucose Monitoring System<br>AutoSure Voice II Pro Blood Glucose Monitoring System |
| Classification | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes | CGA, NBW |
| Predicate Device | AutoSure Voice II Blood Glucose Monitoring System and AutoSure Blood<br>Glucose Test Strips (k102037) |
| Device Description | The AutoSure Voice II Blood Glucose Monitoring System consists of the<br>AutoSure Voice II Meter and AutoSure Blood Glucose Test Strips. It is used<br>for testing of blood glucose by self-testers at home. The AutoSure Voice II<br>Pro Blood Glucose Monitoring System consists of the AutoSure Voice II Pro<br>Meter and AutoSure Pro Blood Glucose Test Strips. It is used for testing of<br>blood glucose by professional testers in healthcare facilities. The AutoSure<br>Voice II and AutoSure Voice II Pro systems are identical other than trade names<br>and details of product labeling. |
| | |
| | The AutoSure Voice II 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. The meter includes voice functionality to assist |
| | 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 to monitoring blood glucose |
| | levels in diabetes mellitus. This system is for single-patient use only and should not be |
| | shared. Alternative site testing should be done only during steady-state times (when |
| | glucose is not changing rapidly). It is not intended for the diagnosis or screening of |
| | diabetes or for neonatal use. |
| | The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II |
| | Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken |
| | from fingertips, palm, or forearm. |
| Intended Use | The AutoSure Voice II Pro Blood Glucose Monitoring System is intended for the<br>quantitative measurement of glucose in fresh capillary whole blood samples drawn<br>from the fingertips, forearm, or palm. The meter includes voice functionality to assist<br>visually impaired users. It is intended for multiple-patient use in professional<br>healthcare settings as an aid in monitoring blood glucose levels in Diabetes Mellitus.<br>This system should only be used with single-use auto-disabling lancing devices.<br>Alternative site testing should be done only during steady-state times (when glucose is<br>not changing rapidly). It is not intended for the diagnosis or screening of diabetes or for<br>neonatal use.<br>The AutoSure Pro Blood Glucose Test Strips are to be used with the AutoSure Voice I<br>Pro Blood Glucose Meter to quantitatively measure glucose in capillary whole blood<br>taken from fingertips, palm, or forearm. |
| Comparison of<br>Technological<br>Characteristics | The modified AutoSure Voice II and AutoSure Voice II Pro Blood Glucose Monitoring<br>Systems are identical to the original (predicate) system other than a) separation of the<br>self-testing and professional usage claims into two products and b) the<br>recommendation of four additional disinfectants in the User's Guides. |
| Non-Clinical<br>Testing | Disinfection (viral inactivation) and "robustness" testing were done to qualify all<br>recommended disinfection solutions. Results demonstrate substantial equivalence to<br>the original (predicate) device. |
| Clinical Testing | No clinical testing was conducted. |
| Conclusion | Testing showed that the modified AutoSure Voice II and AutoSure Voice II Pro Blood<br>Glucose Monitoring Systems are substantially equivalent to the original (predicate)<br>system. |

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## 510(k) Summary (Continued)