GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1

K073137 · Apex BioTechnology Corp. · NBW · Apr 1, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073137
• Device Name: GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1
• Applicant: Apex BioTechnology Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GlucoSure 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.

Device Story

GlucoSure Voice is a blood glucose monitoring system comprising a meter, test strips, and control solutions. It measures glucose in fresh capillary whole blood from fingertips, forearm, or palm. Designed for both home use by patients with diabetes and clinical use by healthcare professionals. Features voice functionality to assist visually impaired users in reading results. The system provides quantitative glucose levels to aid in monitoring diabetes management. Users apply blood to a test strip inserted into the meter; the device processes the sample and displays/announces the glucose concentration. Clinical performance was verified through comparison of fingertip and alternate site testing (AST) results against professional reference methods, utilizing linear regression, Clarke Error Grid, and bias analysis. The device also includes control solutions to validate system performance and user technique.

Clinical Evidence

Clinical testing performed on persons with diabetes to verify performance for fingertip and alternate site testing (palm and forearm). Results compared against professional reference methods. Data analyzed via linear regression, Clarke Error Grid, and bias analysis; results met pass/fail criteria. Voice functionality evaluated with visually impaired users. Non-clinical testing included precision, linearity, and temperature/humidity effects.

Technological Characteristics

System includes meter, test strips, and control solutions. Features voice output for accessibility. Supports capillary whole blood sampling from multiple sites (fingertip, forearm, palm).

Indications for Use

Indicated for quantitative blood glucose measurement in patients with Diabetes Mellitus. Suitable for lay use by individuals with diabetes and clinical use by healthcare professionals. Supports fingertip, forearm, and palm capillary whole blood sampling. Includes voice functionality for visually impaired users.

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

• GlucoTrack BGM (k062799)

Submission Summary (Full Text)

{0}------------------------------------------------

K073137
APR - 1 2008

APR - 1 2008

#### 510(k) Summary :

| Submitter: | Apex BioTechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078 CHINA (TAIWAN)<br>Phone: [phone]<br>FAX: [phone] |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Y.S. Shen<br>Apex BioTechnology Corp.<br>No. 7, Li-Hsin Road V, Hsinchu Science Park<br>Hsinchu, 30078 CHINA (TAIWAN)<br>Phone: [phone]<br>FAX: [phone] |
| Date Prepared: | January 9, 2008 |
| Trade Name: | GlucoSure Voice Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | GlucoTrack BGM, k062799 |
| Device Description: | GlucoSure Voice consists of a meter, test strips, and control solutions<br>for use in measuring blood glucose as an aid to monitor the<br>effectiveness of diabetes control. |
| Intended Use: | The GlucoSure Voice 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. Testing is done outside the<br>body ( <i>In Vitro</i> diagnostic use). The meter includes voice functionality to<br>assist visually impaired users. It is indicated for both lay use by people with<br>diabetes and in a clinical setting by healthcare professionals, as an aid to<br>monitoring levels in Diabetes Mellitus.<br>---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>The Intended Use is the same as that as the predicate but with the<br>addition of 1) Alternate Site Testing and 2) voice functionality. |
| Functional and<br>Safety Testing: | Clinical testing was done with persons with diabetes to verify proper<br>performance for fingerstick and Alternate Site Testing (AST) using<br>palm and forearm blood sampling. Professional fingertip meter<br>results were compared with AST results collected both by professionals<br>and by persons with diabetes. Data were analyzed by linear<br>regression analysis, Clarke Error Grid analysis and bias analysis.<br>Results met pass/fail performance criteria. The clinical evaluation<br>included testing of the voice functionality with visually impaired<br>persons with diabetes.<br>Non-clinical testing of precision, linearity, and temperature and<br>humidity effects was also conducted. |
| Conclusion: | The modification to the original device (adding voice functionality) and<br>to the Intended Use (adding AST sampling) does not adversely affect<br>performance and the modified device is substantially equivalent to the<br>unmodified predicate device. |

{1}------------------------------------------------

# 510(k) Summary (continued)

Apex BioTechnology Corp. GlucoSure Voice Blood Glucose Monitoring System

{2}------------------------------------------------

### 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head facing to the left.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Apex Biotechnology Corp. c/o Mr. Thomas Shen Chairman & CEO No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, Taiwan, R.O.C. 30078 APR - 1 2008

Re: k073137

Trade Name: GlucoSure Voice Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: February 04, 2008 Received: February 15, 2008

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).

{3}------------------------------------------------

Page 2 -

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.v.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use Statement

510(k) Number: k073137

Device Name: GlucoSure Voice Blood Glucose Monitoring System

Indications For Use:

The GlucoSure 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.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

he-Counter Use
TR 801 Subpart C)

X

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Carol C. Benam
Sign-Off

Page 1 of 2

ice of In Vitro Diagnostic Device ation and Safety

K07313

{5}------------------------------------------------

## Indications for Use Statement

510(k) Number: k073137

Device Name: Contrex Plus Glucose Control Solution

(Part of the GlucoSure Voice Blood Glucose Monitoring System)

Indications For Use:

The purpose of the control solution test is to validate the performance of the Blood Glucose Monitoring system using a testing solution with a known range of glucose. A control test that falls within the acceptable range indicates the user's technique is appropriate and the test strip and meter are functioning properly.

Prescription Use _____________ (Part 21 CFR 801 Subpart D)

AND/OR (21 CFR 801 Subpart C)

Over-The-Counter Use X

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

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

Carol C. Benson

---

Division Sign-Off

Page 27

ion Sign-Off

Tice of In Vitro Diagnostic Device fration and Safety

K073137