ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002

K051514 · Hypoguard USA, Inc. · NBW · Oct 4, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051514
• Device Name: ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002
• Applicant: Hypoguard USA, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Oct 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Assure® Pro 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 in clinical settings by healthcare professionals, or at home (over the counter [OTC]) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

Device Story

Hand-held blood glucose meter; uses test strips with lot-specific code chips. User inserts strip; applies fingertip blood or control solution. Meter performs electrochemical assay; converts electrical current (proportional to glucose concentration) to plasma-equivalent glucose value. Displays result on LCD. Features: top-loading strip port, strip-ejection mechanism, adjustable backlight, alarm functions. Used at home by patients or in clinical settings by professionals. Output aids diabetes management decisions.

Clinical Evidence

Clinical study with 100 diabetic participants (ages 18-81) and 10 non-diabetic subjects. Participants performed testing independently. Comparison against YSI reference method. Results: Participant vs. YSI regression y=0.89x+15.6 (r=0.94); Professional vs. YSI regression y=0.91x+12.0 (r=0.96). Clarke Error Grid analysis: 90% of participant results in Zone A, 10% in Zone B; 94% of professional results in Zone A, 5% in Zone B, 1% in Zone D. Bench testing (CLSI EP5-A) showed total CV% of 8.9%.

Technological Characteristics

Portable, battery-operated blood glucose meter. Features: top-loading test strip port, strip-ejection mechanism, backlit display. Quantitative measurement of glucose in fresh capillary whole blood. Electromagnetic compatibility (EMC) testing performed.

Indications for Use

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

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

• Hypoguard Advance Micro-Draw (k020232, k031388, k041881)

Submission Summary (Full Text)

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K os1514

OCT 4 - 2005

# 510(k) Summary

| 1. SUBMITTED BY: | Bruce A. MacFarlane, Ph.D.<br>Hypoguard USA, Inc.<br>5182 West 76th Street<br>Minneapolis, MN 55439<br>USA<br>Phone: [phone] |
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Summary prepared: 6 June 2005

## 2. NAME OF DEVICES:

| Trade Names: | Assure® Pro Blood Glucose Monitoring System |
|----------------------------|-------------------------------------------------------------------|
| | Assure® Pro Blood Glucose Meter |
| | Assure® Pro Test Strips |
| | Assure® Pro Level 1 Control Solution |
| | Assure® Pro Level 2 Control Solution |
| Common Names/Descriptions: | Blood glucose monitoring system |
| Classification Names: | - Glucose test system, product codes CGA & NBW<br>21 CFR 862.1345 |
| | - Single (specified) analyte controls |

(assayed/unassayed), product code JJX, 21 CFR 862.1660

Regulatory Status: Class II

Advance Micro-draw™ Blood Glucose Monitoring PREDICATE DEVICE: System

3. DEVICE DESCRIPTION:

The Assure® Pro Blood Glucose Monitoring System consists of a meter, test strips, and control solution. It is intended for over-the-counter, home use by persons with diabetes 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 Assure® Pro Test Strips.

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Hypoguard USA, Inc.

## 4. INTENDED USE:

The Assure® Pro 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 in clinical settings by healthcare professionals, or at home (over the counter [OTC]) by persons with diabetes, as an aid to monitor the effectiveness of diabetes control.

## 5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The Assure Pro Blood Glucose Monitoring System shares the same technological characteristics as the predicate except that 1) test strips are inserted in the top of the meter (instead of the bottom), 2) there is a strip-eiection mechanism, and 3) there is a backlight to the display screen.

### 6. NON-CLINICAL TESTING

Electromagnetic compatibility (EMC) testing was conducted.

#### 7. CLINICAL TESTING

Accuracy/method correlation testing was done comparing results obtained by participants with diabetes against clinician results and reference method results.

Testing included both men and women, both Type 1 and Type 2 diabetes, ages from eighteen to eighty-two. Tested blood glucose values encompassed the 61-383 mg/dL glucose range. Linear regression statistics showed good correlation between participant, clinician and reference results.

#### 8. CONCLUSIONS FROM TESTING

Testing demonstrated that the performance of Assure Pro was substantially equivalent to that of the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three wing segments, representing health, services, and people. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

OCT 4 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Bruce A. MacFarlane, Ph.D. Vice President, Regulatory Affairs and Quality Systems Hypoguard USA. Inc. 5182 West 76th Street Minneapolis, MN 55439

Re: k051514

> Trade/Device Name: Assure® Pro Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: September 23, 2005 Received: September 27, 2005

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, 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/industry/support/index.html.

Sincerely yours.

Carol C. Benem

Carol C. Benson, M.A. Acting 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

510(k) Number (if known): Kosl 514

Device Name: Assure® Pro Blood Glucose Monitoring System

Indications For Use:

Assure® Pro Blood Glucose Monitoring System:

The Assure Pro 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 clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Assure® Pro Blood Glucose Meter:

The Assure Pro 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 clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Assure® Pro Blood Glucose Test Strips:

Assure Pro Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood when used with the Assure · Pro Blood Glucose Meter. 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 clinical settings by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

Assure® Pro Control Solution:

For use with Assure Pro Blood Glucose Meter and Assure Pro Test Strips as a quality control check to verify the accuracy of blood glucose test results.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use V (21 CFR 807 Subpart C)

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

| Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) | |
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| Division Sign-Off | Page 1 of 1 |
| Office of In Vitro Diagnostic Device | |
| Evaluation and Safety | |
| 510(k) | k051514 |

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