TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM

K042080 · Home Diagnostics, Inc. · JJX · Aug 19, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042080
• Device Name: TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEM
• Applicant: Home Diagnostics, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 19, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The TrackEase Smart System Blood Glucose System is intended for use in the quantitative measurement of glucose in whole blood. The system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control.

Device Story

TrackEase Smart System; blood glucose meter; measures glucose in whole blood samples; provides quantitative results; used by patients with diabetes at home; modification reduces memory capacity from 365 to 200 results; disables morning average calculation/display; updates meter casing appearance; fundamental scientific technology remains unchanged from predicate.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Blood glucose monitoring system; quantitative determination of glucose in whole blood; finger or forearm sampling; Class II device (21 CFR 862.1345).

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 quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG 1 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

k042080 Re:

Trade/Device Name: TrackEASE Smart System Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test System Regulatory Class: Class II Product Code: NBW, JJX Dated: July 30, 2004 Received: August 03, 2004

Dear Ms. DeVincent:

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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

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 (if known): ______K042080

TrackEASE Smart System Blood Glucose Test System Device Name:

Indications For Use:

The TrackEASE Smart System Blood Glucose Test System is intended for the quantitative I 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 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)

Carol C. Benson
Division Sign-Off

Office of in Vitro Diagnostic Device Evaluation and Safety

510K).

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