AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS

K102037 · Apex BioTechnology Corp. · CGA · Aug 13, 2010 · Clinical Chemistry

Device Facts

• Record ID: K102037
• Device Name: AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AutoSure Voice Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger, palm, and forearm. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System measures glucose in capillary whole blood samples; utilizes test strips inserted into meter. Features voice functionality for visually impaired users; includes autocoding feature for test strip calibration. Used by patients at home or healthcare professionals in clinical settings. Meter processes blood sample via test strip; provides quantitative glucose level output. Assists in monitoring Diabetes Mellitus; plasma-calibrated for lab result comparison.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control requirements (21 CFR 820.30) to confirm performance characteristics of modified test strips and meter hardware. FMEA used to assess impact of modifications.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Features voice output for accessibility. Includes autocoding mechanism for test strip calibration. Plasma-calibrated. Software-controlled measurement.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood from finger, palm, and forearm for diabetes management at home. 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 Voice meter and test strips

Submission Summary (Full Text)

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K102037 AUG 1 3 2010

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## 6 510(k) Summary

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| 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>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<br>Hsinchu, 30078<br>CHINA (TAIWAN)<br>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared: | July 2, 2010 |
| Trade Names: | AutoSure Voice II 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 meter and test strips |
| Device Description: | The AutoSure Voice II blood glucose monitoring system consists of a<br>meter and AutoSure test strips. It is used for testing of blood glucose by<br>self-testers at home and for professional testers in healthcare facilities. |
| Intended Use: | <b>System:</b> The AutoSure Voice II Blood Glucose Monitoring System<br>intended for the quantitative measurement of glucose in fresh capillary wh<br>blood samples drawn from the fingertips, forearm, or palm. Testing is do<br>outside the body (In Vitro diagnostic use). The meter includes vo<br>functionality to assist visually impaired users. It is indicated for both lay<br>by people with diabetes and in a clinical setting by healthcare professiona<br>as an aid to monitoring levels in Diabetes Mellitus. It is not indicated for<br>diagnosis or screening of diabetes or for neonatal use.<br><b>Test Strip:</b> The AutoSure Blood Glucose Test Strips are to be used with<br>AutoSure Voice II Blood Glucose Meter to quantitatively measure glucose<br>capillary whole blood taken from fingertips, palm, or forearm. The AutoS<br>Voice II Blood Glucose Monitoring System is plasma-calibrated for ea<br>comparison to lab results. It is intended for self-testing by persons w<br>diabetes and by health care professionals. It is not indicated for the diagno<br>or screening of diabetes or for neonatal use. |
| Comparison of<br>Technological<br>Characteristics: | The AutoSure Voice II meter uses the same test algorithm as the predica<br>The meter has been modified by relocating the 3 operating buttons. Me<br>software has been changed to accommodate the new autocoding feature. T<br>test strip and test strip holder have been modified to allow automa<br>detection of the calibration code upon insertion of the test strip. The t<br>strip is otherwise unchanged from the predicate test strip. |
| Non-Clinical<br>Testing: | Testing was conducted as follows: Software verification and validatic<br>software integration, linearity, Lo/Hi detection, strip holder reliability, dr<br>testing, EMC and Electrical Safety, autocode manufacturing qualificatio<br>and verification of strip noninterchangeability between new and predica<br>devices. Results demonstrate substantial equivalence to the predicate devic |
| Clinical Testing | An accuracy study was performed with blood testing by healthca<br>professionals. A user study was conducted to evaluate ease-of-use of t<br>system and ease-of-understanding of the User's Manual. Resu<br>demonstrate substantial equivalence to the predicate device. |
| Conclusion: | Clinical and non-clinical testing demonstrated that the AutoSure Voice<br>meter and AutoSure test strips perform in a substantially equivalent manr<br>to that of the predicate device. We conclude that the AutoSure Voice<br>meter and AutoSure test strips are substantially equivalent to the predica<br>device |

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510(k) Summary (Continued)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Public Health Service

Apex BioTechnology Corp. c/o Hsue-mei Lee Manager of Quality Assurance Department No. 7, Li-Hsin Road V, Hsinchu Science Park Hsinchu, 30078 China (Taiwan)

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

AUG 13 2000

k102037 Re:

> Trade Name: AutoSure Voice II Blood Glucose Monitoring System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: CGA, NBW Dated: July 2, 2010 Received: July 19, 2010

Dear Mr. 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.

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 Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. 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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Signature

Courtney C. 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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K102037

AUG 1 3 2010

## Indications for Use Statement 5

510(k) Number (if known): 16 102203

Device Name: AutoSure Voice II Blood Glucose Monitoring System

Indications for Use:

AutoSure Voice II Blood Glucose Monitoring System:

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. Testing is done outside the body (In Vitro diagnostic use). The meter includes voice functionality to assist visually impaired users. It is indicated for both lay use by people with diabetes and in a clinical setting by healthcare professionals, as an aid to monitoring levels in Diabetes Mellitus. 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 Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice II Blood Glucose Monitoring System is plasma-calibrated for easy comparison to lab results. It is intended for selftesting by persons with diabetes and by health care professionals. It is not indicated for the diagnosis or screening of diabetes or for neonatal use,

Prescription Use Over-The-Counter Use X 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 (01VD)

Signature

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

510(k) k102037

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