ELEMENT BLOOD GLUCOSE TEST SYSTEM

K060793 · Home Diagnostics, Inc. · NBW · Jul 25, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060793
• Device Name: ELEMENT BLOOD GLUCOSE TEST SYSTEM
• Applicant: Home Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 25, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Element Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The system is intended to be used to assist the patient and healthcare professional in the management of diabetes. For at home use and for use by healthcare professionals in physician’s offices and convalescent care bedside testing facilities.

Device Story

Element Blood Glucose Test System measures glucose in human whole blood samples (finger or forearm). System uses electrochemical biosensor technology with glucose oxidase reagent on test strips. Meter applies voltage to electrodes; measures resulting current proportional to glucose concentration; displays plasma-equivalent glucose value. Designed for use by patients at home or healthcare professionals in clinical settings. Modifications from predicate include reduced test time (5 seconds), reduced memory capacity, and removal of certain user-accessible features (morning averages, date/time display, user-accessible serial port). Output assists in diabetes management.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on bench testing and comparison to predicate technology.

Technological Characteristics

Electrochemical glucose monitoring system; consists of meter and test strips; measures glucose in capillary whole blood; portable form factor for point-of-care or home use.

Indications for Use

Indicated for quantitative glucose determination in human whole blood (finger or forearm) to assist patients and healthcare professionals in diabetes management.

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen De Vincent Director, Regulatory Affairs/Quality Assurance Home Diagnostics, Inc 2400 NW 55th Ct. Ft. Lauderdale, FL 33309

JUL 25 2006

Re: k060793

·

Trade/Device Name: Element Blood Glucose Monitoring System Regulation Number: 21 CFR8862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA Dated: June 30, 2006 Received: July 3, 2006

Dear Ms. De Vincent:

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 Gutz

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): | K060793 |
|---------------------------|-----------------------------------------|
| Device Name: | Element Blood Glucose Monitoring System |

Indications For Use:

The Element Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood taken from the finger or forearm. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

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

Over-The-Counter Use X (21 CFR 801 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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