GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1

K073648 · Apex BioTechnology Corp. · CGA · Apr 10, 2008 · Clinical Chemistry

Device Facts

• Record ID: K073648
• Device Name: GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1
• Applicant: Apex BioTechnology Corp.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Apr 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (in vitro diagnostic use). The GlucoSure Star System is plasma-calibrated for easy comparison to lab results. 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 Star Blood Glucose Monitoring System; electrochemical biosensor; uses capillary action to draw blood into test strip chamber. Glucose oxidase enzyme reacts with glucose in sample; generates electrical current proportional to glucose concentration. Meter converts current to glucose concentration; displays result in 6 seconds. Used by patients (home) or healthcare professionals (clinical setting). Provides quantitative glucose readings to aid diabetes management. Requires single-use test strips and batch-specific code strip for calibration. Supports alternate site testing (palm, forearm) in addition to fingertip.

Clinical Evidence

Consumer study with 152 lay-users comparing fingertip, palm, and forearm samples against YSI 2300 reference. Results: 100% of fingertip samples (≥75 mg/dL) within ±20% of YSI; 99-100% of alternate site samples within ±20% of fingertip reference. No clinical sensitivity/specificity data required for this device type.

Technological Characteristics

Glucose test system (21 CFR 862.1345). Includes meter, test strips, and control solutions. Plasma-calibrated. Supports alternate site testing (fingertip, palm, forearm).

Indications for Use

Indicated for people with diabetes (lay users) and healthcare professionals (clinical setting) for quantitative glucose measurement in fresh capillary whole blood from fingertips, palm, or forearm as an aid to monitor Diabetes Mellitus.

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 Blood Glucose Monitoring System (k062799)

Submission Summary (Full Text)

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K073648

APR 11.0 2008

# 5 510(k) Summary

| Submitter: | 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] |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Thomas Y.S. Shen |
| Date Prepared: | December 21, 2007 |
| Trade Name: | GlucoSure Star Blood Glucose Monitoring System |
| Classification: | Glucose test system, 21 CFR 862.1345, Class II |
| Product Codes: | CGA, NBW, JJX |
| Predicate Device: | GlucoTrack Blood Glucose Monitoring System (k062799) |
| Device<br>Description: | GlucoSure Star 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 GlucoSure Star Blood Glucose Monitoring System is<br>intended for the quantitative measurement of qlucose in fresh<br>capillary whole blood taken from fingertips, palm, or forearm.<br>Testing is done outside the body (In Vitro diagnostic use). It is<br>indicated for both lay use by people with diabetes and in a<br>clinical setting by healthcare professionals, as an aid to<br>monitoring levels in Diabetes Mellitus."<br>The GlucoSure Star is identical to the GlucoTrack except for the<br>addition of the palm and forearm sampling site claims. |
| Functional and<br>Safety Testing: | Clinical testing was done with persons with diabetes to verify<br>proper performance for Alternate Site Testing (AST) using palm<br>and forearm blood sampling. Professional fingertip meter results<br>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. |
| Conclusion: | The addition of the AST blood sampling claim does not adversely<br>affect performance of the device. The new device with the<br>modified AST blood sampling claim is substantially equivalent to<br>the predicate device with its original Intended Use. |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Apcx Biotechnology Corp. c/o Mr. Thomas Y. S. Shen Chairman & CEO No. 7, Li-Hsin Road V Hsinchu Science Park Hsinchu, 30078 Taiwan, ROC

## APRIC 2008

Re: k073648

> Trade Name: Glucosure Star Blood Glucose Monitoring System, Model as90000e1 Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Monitoring System Regulatory Class: Class II Product Codes: NBW, CGA Dated: February 21, 2008 Received: February 25, 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).

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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.

Yéan 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

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### Indications for Use Statement

510(k) Number (if known): ≤673648

Device Name: GlucoSure Star Blood Glucose Monitoring System

Indications For Use:

GlucoSure Star Blood Glucose Monitoring System:

The GlucoSure Star Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood taken from fingertips, palm, or forearm. Testing is done outside the body (In Vitro diagnostic use). The GlucoSure Star System is plasma-calibrated for easy comparison to lab results. 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.

GlucoSure Star Test Strips:

The GlucoSure Star Blood Glucose Test Strips are to be used with the GlucoSure Star Blood Glucose Meter to quantitatively measure glucose in capillary whole blood taken from fingertips, palm, or forearm.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

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

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S100(2) K073649