AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9

K090043 · Apex BioTechnology Corp. · CGA · Apr 9, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090043
• Device Name: AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Apr 9, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Glucosure 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. It is intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of diabetes control programs. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System comprises blood glucose meter, test strips, and control solutions. Input: fresh capillary whole blood sample applied to test strip. Meter performs electrochemical measurement of glucose concentration. Output: quantitative glucose result displayed on screen and announced via integrated voice functionality for visually impaired users. Used in home or clinical settings by patients or healthcare professionals. Results assist in monitoring diabetes control effectiveness. System is plasma-calibrated for lab result comparison.

Clinical Evidence

Bench testing only. Submitter provided design control activities summary, including risk analysis and verification/validation results, to demonstrate that modifications met predetermined acceptance criteria.

Technological Characteristics

Electrochemical glucose test system. Includes meter, test strips, and control solutions. Features integrated voice output for accessibility. Plasma-calibrated. Class II device (21 CFR 862.1345).

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood (fingertip, forearm, palm) for diabetes management. For lay use by diabetics and clinical use by healthcare professionals. 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

• GlucoSure Voice BGM System

Submission Summary (Full Text)

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## APR 0 9 2009

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## 5 510(k) Summary

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| Submitter: | Thomas Y.S. Shen, Chairman & CEO<br>Apex BioTechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078, CHINA (TAIWAN) |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Y.S. Shen, Chairman & CEO<br>Apex BioTechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078, CHINA (TAIWAN)<br>email: [e-mail]<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared: | December 31, 2008 |
| Trade Name: | AutoSure Voice Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | GlucoSure Voice BGM System |
| Device<br>Description: | AutoSure Voice consists of a meter, test strips, and control<br>solutions for use in measuring blood glucose as an aid to monitor<br>the effectiveness of diabetes control |
| Intended Use: | The AutoSure Voice Blood Glucose Monitoring System is intended<br>for the quantitative measurement of glucose in fresh capillary<br>whole blood samples drawn from the fingertips, forearm, or palm.<br>Testing is done outside the body ( <i>In Vitro</i> diagnostic use). The<br>meter includes voice functionality to assist visually impaired users.<br>It is indicated for both lay use by people with diabetes and in a<br>clinical setting by healthcare professionals, as an aid to monitoring<br>levels in Diabetes Mellitus. |
| Functional and<br>Safety Testing: | Linearity testing confirmed that the use of a preset meter<br>calibration code did not have an adverse effect on accuracy or<br>precision. The ability to detect results below and above the<br>reportable range and to display Lo and Hi, respectively, was<br>verified. Software verification and validation demonstrated that<br>modifications did not lead to software defects in system function. |
| Conclusion: | The modification to the original device does not adversely affect<br>performance and the modified device is substantially equivalent to<br>the unmodified predicate device. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with outstretched wings.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 0 9 2009

Apex BioTechnology Corporation c/o Thomas Y.S. Shen No.7, Li-Hsin Road V Hsinchu Science Park Hsinshu, China (Taiwan) 30078

> Re: k090043 Trade Name: AutoSure Voice 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: March 10, 2009 Received: March 13, 2009

Dear Mr. Shen:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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" (21CFR Part 807.97). 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/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

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

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## 4. Indications for Use Statement

510(k) Number (if known): k090043

Device Name: AutoSure Voice Blood Glucose Monitoring System

Indications For Use:

AutoSure Voice Blood Glucose Monitoring System:

The AutoSure Voice 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 Voice Test Strips:

The AutoSure Voice Blood Glucose Test Strips are to be used with the AutoSure Voice Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm. The AutoSure Voice System is plasma-calibrated for easy comparison to lab result. The AutoSure Voice Blood Glucose Monitoring System is intended for self-testing 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 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)

Carol Benam
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