AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP

K102481 · Apex BioTechnology Corp. · NBW · Apr 28, 2011 · Clinical Chemistry

Device Facts

• Record ID: K102481
• Device Name: AUTOSURE VOICE 3 BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIP
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is intended for single patient use only.

Device Story

Blood glucose meter; modified version of AutoSure Voice II; input: blood sample via lancing device; output: blood glucose concentration; used by patients for self-monitoring; modification includes name change to AutoSure Voice 3, altered dimensions, and button relocation; device validated for 1825 cleaning/disinfection cycles using DISPATCH cleaner disinfectant towels (EPA #56392-8) to simulate 5-year lifespan; fundamental scientific technology remains unchanged.

Clinical Evidence

Bench testing only. Validation performed on cleaning/disinfection durability (1825 cycles) using DISPATCH disinfectant towels to ensure no degradation of materials or performance over simulated 5-year use.

Technological Characteristics

Plasma-calibrated electrochemical glucose monitoring system. Includes voice functionality. Uses same test algorithm and test strips as predicate. Software verification/validation, linearity, strip holder reliability, and EMC/Electrical safety testing performed.

Indications for Use

Indicated for single patient use as a blood glucose monitoring system.

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 meter and AutoSure test strips

Submission Summary (Full Text)

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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<br>Hsinchu, 30078<br>CHINA (TAIWAN)<br><br>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
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| 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: | April 18, 2011 |
| Trade Names: | AutoSure Voice 3 Blood Glucose Monitoring System,<br>AutoSure Blood Glucose Test Strips |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW |
| Predicate Devices: | AutoSure Voice II meter and AutoSure test strips |
| Device Description: | The AutoSure Voice 3 blood glucose monitoring system consists of the<br>AutoSure Voice 3 meter and AutoSure Test Strips. It is used for testing<br>of blood glucose by self-testers at home. |

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510(k) Summary (Continued)

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| Intended Use: | <b>System:</b> The AutoSure Voice 3 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. Testing is done<br>outside the body (In Vitro diagnostic use). It is indicated for lay use by<br>people with diabetes as an aid to monitoring levels in Diabetes Mellitus and<br>should only be used by a single patient. It is not indicated for the diagnosis<br>or screening of diabetes or for neonatal use.<br><br><b>Test Strip:</b> The AutoSure Blood Glucose Test Strips are to be used with the<br>AutoSure Voice II and AutoSure Voice 3 Blood Glucose Meters to<br>quantitatively measure glucose in capillary whole blood taken from<br>fingertips, palm, or forearm. The AutoSure Voice II and AutoSure Voice 3<br>Blood Glucose Monitoring Systems are plasma-calibrated for easy<br>comparison to lab results. They are intended for self-testing by persons with<br>diabetes and should be used by a single patient. They are not indicated for<br>the diagnosis or screening of diabetes or for neonatal use. |
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| Comparison of<br>Technological<br>Characteristics: | The AutoSure Voice 3 meter uses the same test algorithm, test strip, and<br>control solutions as the predicate. Meter dimensions and button locations<br>were modified relative to the predicate. |
| Non-Clinical<br>Testing: | Testing was conducted as follows: Software verification and validation,<br>software integration, linearity, strip holder reliability, test strip<br>noninterchangeability, and EMC & Electrical Safety. Results demonstrate<br>substantial equivalence to the predicate device. |
| Clinical Testing | An accuracy study was performed with blood testing by healthcare<br>professionals. Results demonstrate substantial equivalence to the predicate<br>device. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the AutoSure Voice 3<br>meter with the AutoSure Test Strip perform in a substantially equivalent<br>manner to that of the predicate device. We conclude that the AutoSure Voice<br>3 system is substantially equivalent to the predicate device. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with flowing lines, representing the department's mission of health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol, emphasizing the department's name and national scope.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

**APR 28 2011**

Apex Biotechnology Corp. c/o Ms. Lisa Liu No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, China (Taiwan) 30078

Re: k102481

> Trade Name: AutoSure Voice 3 Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: April 18, 2011 Received: April 20, 2011

Dear Ms. 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CFR Parts 801 and 5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

C.C.

Courthey Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known): k102481

Device Name: AutoSure Voice 3 Blood Glucose Monitoring System Indications for Use:

AutoSure Voice 3 Blood Glucose Monitoring System:

The AutoSure Voice 3 Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood samples drawn from the fingertips, forearn, or palm. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for lay use by people with diabetes as an aid to monitoring levels in Diabetes Mellitus and should only be used by a single patient. It is not indicated for the diagnosis or screening of diabetes or for neonatal use.

AutoSure Blood Glucose Test Strips:

The AutoSure Blood Glucose Test Strips are to be used with the AutoSure Voice II and AutoSure Voice 3 Blood Glucose Meters to quantitatively measure glucose in capillary whole Hood taken from fingertips, palm, or forearm. The AutoSure Voice II and AutoSure Voice 3 Blood Glucose Monitoring Systems are plasma-calibrated for easy comparison to lab results. They are intended for self-testing by persons with diabetes and should only be used by a single patient. They are not indicated for the diagnosis or screening of diabetes or for neonatal use.

Prescription Use J Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division of

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) R/024