ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001

K053079 · Hypoguard USA, Inc. · CGA · Mar 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053079
• Device Name: ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460001
• Applicant: Hypoguard USA, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Mar 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

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 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.

Device Story

Assure Pro Blood Glucose Monitoring System measures glucose in fresh capillary whole blood; uses electrochemical enzymatic (glucose oxidase) assay. System includes portable battery-operated meter, disposable test strips, and control solutions. User inserts strip into meter; applies fingerstick blood sample; meter performs measurement in 10 seconds. Calibration achieved via strip-specific electronic key. Meter stores 250 results; calculates 7, 14, and 30-day moving averages; provides audible alarms for low glucose. Used by diabetics for self-monitoring or healthcare professionals in clinical settings. Output (plasma equivalent glucose concentration) aids in diabetes management decisions. System performance validated for hematocrit 30-55% and temperature 15-35°C.

Clinical Evidence

User study conducted with 159 diabetic participants (ages 16-78, Type 1, Type 2, gestational). Participants performed self-testing; results compared to YSI laboratory reference method. Performance evaluated via ISO 15197 criteria. Analytical performance included precision (CV% 4.0-6.1%), linearity (20-600 mg/dL), and interference testing per CLSI EP07-A2. Results demonstrate substantial equivalence to predicate and compliance with ISO 15197 standards.

Technological Characteristics

Portable, battery-operated blood glucose meter. Uses test strips and control solution for in vitro diagnostic quantitative glucose measurement. System designed for fresh capillary whole blood analysis. Technological characteristics identical to original version, with modifications focused on reduced minimum sample volume.

Indications for Use

Indicated for persons with diabetes (home/OTC) and healthcare professionals (clinical settings) for quantitative measurement of glucose in fresh capillary whole blood 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.

Predicate Devices

• Assure Pro Blood Glucose Monitoring System (k051514)

Submission Summary (Full Text)

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K053079

# MAR 2 8 2006

## 510(k) SUMMARY

1. SUBMITTED BY:

Bruce A. MacFarlane, Ph.D. Hypoguard USA, Inc. 5182 West 76th Street Minneapolis, MN 55439 952-646-3188 (phone) 952-646-3110 (fax)

Summary prepared: 28 October 2005

2. NAME OF DEVICE:

Trade Name:

Common Names/Descriptions:

Classification Names:

Assure Pro Blood Glucose Monitoring System

Blood glucose monitoring system

"Glucose test system", product code 75CGA and "System, test, blood glucose, over the counter", product code 75NBW, 21 CFR 862.1345

- 3. PREDICATE DEVICE: Assure Pro Blood Glucose Monitoring System
- 4. 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 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 Assure Pro Blood Glucose Test Strips.

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

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# 6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The modified Assure Pro System has the same technological characteristics as the original system.

## 7. NON-CLINICAL TESTING

Successful testing was done to confirm the reduced minimum sample volume claim and to verify key performance characteristics including precision, hematocrit range, and interferences.

### 8. CLINICAL TESTING

Test strips were tested with fresh capillary whole blood to verify performance was not compromised by the modifications. Testing confirmed appropriate performance.

### 9. CONCLUSIONS FROM TESTING

Testing demonstrated that the performance of the modified Assure Pro was substantially equivalent to that of the unmodified version.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

VAR 2 8 2006

Bruce A. MacFarlane, Ph.D. Vice President, Regulatory Affairs and Quality Systems Hypoguard USA, Inc. 5182 West 7610 Street Minneapolis, MN 55439

Re: k053079

> Trade/Device Name: Assure® Pro Blood Glucose Monitoring System Assure® Pro Blood Glucose Meter Assure® Pro Blood Glucose Test Strips Assure® Pro Control Solution Regulation Number: 21 CFR& 862.1345 Regulation Name: Glucose test system

Regulatory Class: Class II Product Code: CGA, NBW, JJX Dated: March 9, 2006 Received: March 10, 2006

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.

Alberto Gutierrez, Ph.D.

Alberto Gutierrez, Ph.D. 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): K053019

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 qlucose 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). They are 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)

CAC

Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

K053079