MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM

K031388 · Hypoguard USA, Inc. · CGA · May 22, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031388
• Device Name: MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Hypoguard USA, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: May 22, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Hypoquard Advance Blood Glucose Monitoring 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 healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Device Story

System comprises portable battery-operated meter, test strips, and control solution. Used for in vitro quantitative measurement of glucose in fresh capillary whole blood. Operated by patients at home or healthcare professionals in clinical settings. User applies blood sample to test strip inserted into meter; device performs electrochemical measurement of glucose concentration. Output displayed on meter screen; assists in monitoring diabetes control effectiveness. Control solution used to verify system accuracy.

Clinical Evidence

Clinical accuracy and method correlation study compared modified system against original system and YSI 2300 reference analyzer. Study population included men and women, ages 19 to 80s, with Type I and Type II diabetes. Tested glucose range: 25-80 mg/dL to >250 mg/dL. Results met acceptance criteria, including Clarke Error Grid Analysis.

Technological Characteristics

Portable, battery-operated blood glucose meter. Uses electrochemical test strips and control solution for in vitro diagnostic measurement. Quantitative measurement of glucose in fresh capillary whole blood.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood for home (OTC) use by persons with diabetes or in clinical settings by healthcare professionals to monitor diabetes control effectiveness.

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.

Reference Devices

• YSI 2300 analyzer

Submission Summary (Full Text)

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K031388

MAY 22 2003

# 510 (k) SUMMARY

| 1. SUBMITTED BY: | Bruce A. MacFarlane, Ph.D.<br>Hypoguard USA, Inc.<br>5182 West 76 ^th Street<br>Minneapolis, MN 55439<br>952-646-3188 (phone)<br>952-646-3110 (fax)<br>Summary prepared: 29 April, 2003 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. NAME OF DEVICE: | |
| Trade Name: | Hypoguard Advance Blood Glucose Monitoring<br>System |
| Common Names/Descriptions: | Blood glucose meter system |
| Classification Names: | Glucose test system, product code 75CGA, 21<br>CFR 862.1345 |

Hypoguard Advance Blood Glucose Monitoring System

## 4. DEVICE DESCRIPTION:

3. PREDICATE DEVICE:

The Hypoquard Advance Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by diabetics to monitor their blood glucose levels, or for use in a clinical setting by health care professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument designed for use with Hypoguard Advance Blood Glucose Test Strips.

- 5. INTENDED USE:
This modification does not alter the original intended use:

The Hypoquard Advance Blood Glucose Monitoring 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 healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

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# 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The modification has not altered the Hypoquard Advance Blood Glucose Monitoring System technological characteristics.

The modified Hypoquard Advance System has the same technological characteristics as the original device.

## 7. NON-CLINICAL TESTING

Precision Study: Testing was performed identically to the original Advance 510(k). Within run, between run and total CV% were calculated identically to original 510(k). Acceptance criteria were met. Dynamic range claims and minimum sample volume claims were validated.

## 8. CLINICAL TESTING

Accuracy/method correlation testing was done comparing the modified Hypoquard Advance System against the original Hypoquard Advance System and the YSI 2300 analyzer (reference method). Testing included both men and women, both Type I and Type II diabetes, ages from nineteen to the eighties, and a wide range of educational levels. Tested blood glucose values encompassed the 25-80 mq/dL range on the low end to values over 250 mg/dL at the high level. Acceptance criteria were met, including Clarke Error Grid Analysis.

## 9. CONCLUSIONS FROM TESTING

Testing demonstrated that the results were within acceptance criteria. Therefore the modification did not adversely affect performance characteristics.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circle around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 22 2003

Bruce A. MacFarlane, Ph.D. Quality Assurance Manager Hypoguard USA, Inc. 5182 West 76th Street Minneapolis, MN 55439

Re: k031388

Trade/Device Name: Hypoguard Advance Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: NBW, CGA Dated: April 29, 2003 Received: May 2, 2003

Dear Dr. MacFarlane:

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. Iisting 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). Other general information on your responsibilities under the Act may be obtained 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 Sutman

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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## INDICATIONS FOR USE

510(k) Number (if known):

Hypoquard Advance Blood Glucose Monitoring System Device Name:

#### Indications For Use:

Hypoquard Advance Blood Glucose Monitoring System:

The Hypoquard Advance Blood Glucose Monitoring 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 healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Hypoquard Advance Blood Glucose Meter:

The Hypoquard Advance Blood Glucose Meter 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 healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Hypoquard Advance Blood Glucose Test Strips:

The Hypoquard Advance Blood Glucose Meter is intended for the quantitative measurement of dlucose 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 (OTC1) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Hypoquard Advance Control Solution:

Hypoquard Advance Control Solution is intended for use with the Hypoquard Advance Meter and Hypoquard Advance Test Strips as a quality control check to verify the accuracy of blood qlucose test results.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use

Prescription Use (Per 21 CFR 801.109)

Dean Cooper
Division Sign-Off

OR

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K031388

(Optional Format 3-10-98)

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