BLOOD GLUCOSE MONITORING SYSTEM

K043543 · American Healthcare, Inc. · NBW · Apr 8, 2005 · Clinical Chemistry

Device Facts

• Record ID: K043543
• Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: American Healthcare, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Apr 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Freedom Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The Freedom Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh, and calf.

Device Story

System uses electrochemical biosensor technology to measure glucose in whole blood; utilizes glucose oxidase enzyme on carbon electrodes. User applies blood sample to test strip; meter performs amperometric measurement; displays quantitative glucose result. Used in home or clinical settings by patients or healthcare professionals. Provides plasma-equivalent results; includes memory function for tracking averages and test history. Benefits patient by enabling self-monitoring of blood glucose levels for diabetes management.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics to predicate devices.

Technological Characteristics

In vitro diagnostic device; electrochemical sensing principle using dehydrogenase glucose reaction; generates electrical current proportional to glucose concentration; handheld meter form factor; intended for home and clinical use.

Indications for Use

Indicated for quantitative blood glucose measurement in patients with diabetes to monitor management effectiveness. Suitable for home and clinical use. Testing sites include fingertip, arm, palm, thigh, and calf.

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

• LifeScan, Inc. OneTouch® Ultra® (K024194)
• LifeScan, Inc. SURESTEP® (K984261)
• Roche Diagnostics Corp. Accu-Chek Advantage (K021513)

Submission Summary (Full Text)

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K043543

American HealthCare, Inc. 510(k) for In Vitro Diagnostic Device

### 510(k) SUMMARY

(As required by 21.CFR.807.92)

| Introduction: | According to the requirements of 21 CFR.807.92, the following<br>information provides sufficient data to understand the basis for a<br>determination of substantial equivalence. |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitted By: | American HealthCare, Inc.<br>304 Park Avenue South<br>Suite 218<br>New York, NY 10010 |
| Contact Person: | Edward Letko<br>Phone: [phone]<br>Fax: [phone] |
| Date Summary,<br>Prepared: | December 14, 2004 |
| Device Name: | Propriety Name: FREEDOM Blood Glucose Monitoring System<br>Common Name: Blood Glucose Test System<br>Classification Name: Class II, 862.1345 Glucose Blood Tester |
| Predicate Device: | We claim substantial equivalence to the LifeScan, Inc.,<br>OneTouch® Ultra®. |
| Device<br>Description: | The FREEDOM Blood Glucose Monitoring System is an in vitro<br>diagnostic device designed for measuring the concentration of glucose in<br>whole blood, which is used with the FREEDOM Test Strips.<br><br>The test principle is:<br><br>This device is an in vitro diagnostic product intended for the<br>measurement of glucose concentration in human blood. The principle of<br>the test relies upon a specific type of glucose in the blood sample, the<br>dehydrogenase glucose that reacts to electrodes in the test strip. The test<br>strip employs an electrochemical signal generating an electrical current<br>that will stimulate a chemical reaction. This reaction is measured by the<br>Meter and displayed as your blood glucose result. |
| Intended Use: | The FREEDOM Blood Glucose Monitoring System, is used for the<br>quantitative measurement of glucose in whole blood as an aid in<br>monitoring the effectiveness of diabetes management in the home and in<br>clinical settings. The FREEDOM Blood Glucose Monitoring System is<br>for |
| testing outside the body (in vitro diagnostic use only). Testing site<br>include the traditional fingertip testing along with alternate site<br>testing on the arm, palm, thigh and calf. | |
| Comparison to | |
| Predicate Device: | The US Diagnostics, Inc. FREEDOM Blood Glucose Monitoring<br>System is substantially equivalent to the other products in<br>commercial distribution intended for similar use. The most<br>notable, it is substantially equivalent to the currently marketed<br>item, the OneTouch® Ultra® by LifeScan, Inc. |
| Conclusion: | The FREEDOM Blood Glucose Monitoring System is<br>substantially equivalent to the following predicate devices:<br>K024194 - LifeScan, Inc. OneTouch® Ultra®<br>K984261 - LifeScan, Inc. SURESTEP®<br>K021513 - Roche Diagnostics Corp. Accu-Chek Advantage |

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# American HealthCare, Inc.

.

:

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510(k) for In Vitro Diagnostic Device

# 510(k) Summary, Continued

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its head, representing the department's mission to promote health and well-being. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The logo is simple and recognizable, conveying the department's role in public health and human services.

APR 8 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Edward Letko Managing Director American HealthCare Inc. 304 Park Avenue South Suite 218 New York, NY 10010

Re: k043543

Trade/Device Name: FREEDOM Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: March 2, 2005 Received: March 2, 2005

Dear Mr. Letko

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,

Jean M. Cooper, MS, DVM

Jean M. Cooper, MS. 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

510(k) Number: k043543

Device Name: FREEDOM Blood Glucose Monitoring System

Indications For Use: The FREDOM Blood Glucose Monitoring System is used for the quantitative measurement of glucose level in whole blood as an aid in monitoring the effectiveness of diabetes management in the home and in clinical settings. The FREEDOM Blood Glucose Monitoring System is for testing outside the body (in vitro diagnostic use only). Testing sites include the traditional fingertip testing along with alternate site testing on the arm, palm, thigh and calf.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)

Page 1 of 1

Carol Benem
Division Sign-Off

Office of in vitro Diagnostic Device Evaluation and Safety

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