GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM

K032985 · Hmd Biomedical, Inc. · NBW · Oct 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032985
• Device Name: GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
• Applicant: Hmd Biomedical, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 21, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The GlucoLeader Enhance Self-Monitoring of Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Device Story

System consists of glucose meter and bio-active electrode (test strip) containing glucose oxidase. Capillary blood sample drawn into strip via capillary action; glucose reacts with reagent to produce potassium ferrocyanide. Oxidation of ferrocyanide generates electrical current proportional to glucose concentration; meter converts current to glucose value. Used by patients (home) or healthcare professionals (clinical) to monitor diabetes control. Features include memory storage, date/time settings, and RS232 data download. Output displayed on LCD; informs clinical decision-making regarding diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design control activities, risk analysis, and verification/validation of modifications.

Technological Characteristics

Glucose oxidase electrochemical biosensor. Meter dimensions: 95x60x18.5mm; weight: 70g. Power: 0.15V. Connectivity: RS232 interface for data download. Measuring range: 30-600 mg/dL. Hematocrit range: 30-50%.

Indications for Use

Indicated for self-monitoring of blood glucose levels in patients with diabetes.

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

• GlucoLeader™ Value Self-Monitoring of Blood Glucose System (K032985)

Submission Summary (Full Text)

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GlucoLeuder™ Enhunce Self-Monitoring of Blovd Glucose System
September 2003 Special 510(k) Submission-September. 2003

| OCT 21 2003 | Special 510(k) Submission-September. 2003 |
|------------------------|-------------------------------------------------------------------------------------------------------|
| | Special 510 (k) SUMMARY |
| | This summary of 510(k) safety and effectiveness information is being submitted in accordance with the |
| | requirements of SMDA 1990 and 21 CFR 807.92 |
| | The assigned 510(k) number is: K032985 |
| Introduction: | According to the requirements of 21 CFR 862.1345, the |
| | following information provides sufficient detail to understand the |
| | basis for a determination of substantial equivalence. |
| Submitter: | HMD BIOMEDICAL, Inc. |
| Address: | 3 F, No. 324, Sec. 1, Chunghwa Rd. Hsinchu, Taiwan, 300 |
| Contact Number: | Phone: [phone] |
| | Fax:<br>886-3-5354633 |
| Contact Person: | Jeffery Fleishman |
| | Official Correspondent |
| Date Prepared: | Sep.10.2003 |
| Device Name: | |
| Proprietary name: | GlucoLeader™ Enhance Self-Monitoring of Blood Glucose |
| | System |
| Common name: | Glucose Meter |
| Classification name: | NBW (System, Test Blood Glucose, over the Counter) |
| Device Classification: | Glucose Test System per21 CFR 862.1345 |
| | Class II Device |
| Predicate Device: | |
| Name: | GlucoLeaderTM Value Self-Monitoring of Blood Glucose |
| | System |
| Manufacturer: | HMD BioMedical Inc. |
| | 3 F, No. 324, Sec. 1, Chunghwa Rd. Hsinchu, Taiwan, 300 |
| 510(k) Number: | K023279 |
| | |

·

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### Test Principle:

The GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System is comprised of two main parts a bio-active electrode (test strip) containing the enzyme glucose oxidase and the glucose meter. The blood sample is drawn into the Test Strip through capillary action. Glucose in the sample reacts with glucose oxidase and potassium ferricyanide in the strip, ferrocyanide. Potassium producing ferrocyanide is produced in proportion to the glucose concentration of the blood sample .Oxidation of the potassium ferrocyanide produces an electrical current which is then converted by the meter to display the glucose concentration.

The GlucoLeader Enhance Self-Monitoring of Blood Intended Use: Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, this device is not suitable for neonate samples. Similarities:

The proposed modification is relatively modest in scope. All of the following are claims and features unaffected by the proposed modification

| Feature/Claim | Detail |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The GlucoLeader Enhance Self-Monitoring of Blood<br>Glucose System is intended for the quantitative measurement<br>of glucose in fresh capillary whole blood. Testing is done<br>outside the body (in vitro diagnostic use). It is indicated for<br>use at home (over the counter [OTC]) by persons with<br>diabetes, this device is not suitable for neonate samples. |
| Test Principle | The GlucoLeader Enhance Self-Monitoring of Blood<br>Glucose System is base on the measurement of electrical<br>current caused by the reaction of glucose with the reagent<br>(Glucose Oxidase method) on the electrode of the strip. |
| Warnings and Precautions | For in-vitro diagnostic use only |
| Specimen Type | Capillary whole blood |
| Sample volume | Both need 3uL capillary whole blood |

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| Measuring Time | Both within 15 seconds |
|-----------------------------|------------------------------------------------------------------------------|
| System Performance | Both use two levels quality control solution to check system<br>performance. |
| Measuring Range | Both in 30~600 mg/dL |
| Acceptable Hematocrit Range | 30-50 % |

# Differences:

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

| Feature | GlucoLeader™ Enhance<br>Self-Monitoring of Blood<br>Glucose System<br>(modified) | GlucoLeader™ Value<br>Self-Monitoring of Blood<br>Glucose System<br>(predicate) |
|----------------------------|------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Meter Dimension | 95 (L)*60 (W)*18.5(H)mm | 93(L)*38(W)*18(H)mm |
| Weight | Approximate 70g (with<br>battery) | Approximate 30g(with<br>battery) |
| Electrics voltage | 0.15V | 0.41V |
| Measuring current limited | 50μA | 75μA |
| Button | Left: Function key<br>Right: Memory, Setting key | No button |
| Setting function | Setting date, time and unit | NA |
| Data download | Test results can download by<br>RS232 interface | NA |
| Average result with memory | Calculate mean results within<br>7,14,21 and 28 days | NA |
| Ready to test symbol. | User can apply blood to the<br>strip after the<br>Image: display<br>on LCD. | User can apply blood to<br>the strip after the 「bLd」<br>display on LCD |
| Flashing strip symbol | Press any button to power<br>on, the code number and<br>Image: flashing strip symbol<br>will display | NA |

The detail differences listing are shown on "Substantial Equivalent Table".

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Data The results conducted at consumer and point-of-care studies demonstrated consistent quality performance of. GlucoLeader"™ Enhance Demonstrating substantial Self-Monitoring of Blood Glucose System. These study demonstrated good correlation(R>0.98) between 40~400 mg/dl of capillary whole blood equivalence: specimens. With these data it is proved that the regression analysis of the system is equivalent predicate device

#### Consumer Study

Linear regression between GlucoLeader Enhance (GEB) and YSI for lay users and technician

| Accuracy of lay users compared to YSI<br>using capillary whole blood on 180<br>specimens at clinical centers | N=180<br>Y=0.9684X+2.3058<br>R=0.987<br>Sy.x=13.65205<br>Range=64-539mg/dL |
|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Accuracy of technician compared to YSI<br>using capillary whole blood on 180<br>specimens at clinical centers | N=180<br>Y=0.9934X-2.3866<br>R=0.981<br>Sy.x=19.0268<br>Range=68-539mg/dL |

#### Point-Of-Care Study

Linear regression between GlucoLeader Enhance (GEB) and GlucoLeader Value (GVA) for test on department of Home Medical, Internal, and Metabolism

| Home Medical | Metabolism | Internal | Total |
|-------------------|-------------------|-------------------|-------------------|
| N=50 | N=50 | N=50 | N=150 |
| Y=0.969X+6.82 | Y=0.9168X+8.87 | Y=0.9982X-6.57 | Y=0.9573X+4.37 |
| R=0.989 | R=0.986 | R=0.982 | R=0.986 |
| Sy.x=12.65 | Sy.x=10.36 | Sy.x=16.49 | Sy.x=13.78 |
| Range=68-388mg/dL | Range=71-298mg/dL | Range=72-411mg/dL | Range=68-411mg/dL |

### Conclusion:

According to the tests consisted of system function, hardware, software, packaging, electrical safety and laboratory, clinical evaluations, these design modified can be verified and validated demonstrating that the performance of the GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System will not affected safety and effectiveness.

Test demonstrated that the performance of the GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System was substantially equivalent to predicate device

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HMD BIOMEDICAL, INC. c/o Mr. Jeffery Fleishman Official Correspondent Immunostics, Inc. 3505 Sunset Avenue Ocean, NJ 07712

OCT 2 1 2003

Re: k032985

> Trade/Device Name: GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: CGA Dated: September 22, 2003 Received: September 24, 2003

Dear Mr. Fleishman:

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 (OS) 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,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# INDICATION FOR USE STATEMENT

# 510(k) Number (if known): _(032985_

Device Name:

GlucoLeader™ Enhance Self-Monitoring of Blood Glucose System

Indications for Use: The GlucoLeader Enhance Self-Monitoring of Blood Glucose System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter [OTC]) by persons with diabetes, or in a clinical setting by health care professionals, as an aid to monitor the effectiveness of diabetes control.

Carol PC Benson for Dean Cooper, DVM
**Division Sign-Off**

ice of In Vitro Diagnostic Device luation and Sa 510(k) K03 2 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR Over-the-Counter Use

(Per 21 CFR 801.109)