MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL

K040670 · Home Diagnostics, Inc. · NBW · Mar 25, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040670
• Device Name: MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, TEST STRIPS AND GLUCOSE CONTROL
• Applicant: Home Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Device Story

TrueTrack Smart System; blood glucose meter, test strips, and control solution; measures glucose in whole blood; used by patients at home and healthcare professionals in clinical settings. Modification adds serial cable accessory for data transfer from meter to personal computer. Fundamental scientific technology remains unchanged from predicate. Device provides glucose monitoring data to aid diabetes management.

Clinical Evidence

Bench testing only. Validation protocols addressed hazards identified in the risk analysis (FMEA).

Technological Characteristics

Electrochemical glucose test system; quantitative measurement of glucose in whole blood.

Indications for Use

Indicated for quantitative glucose determination in human whole blood 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

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Public Health Service

MAR 2 5 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Karen De Vincent Director of Regulatory Affairs Home Diagnostics, Inc. 2400 NW 550 Ct. Fort Lauderdale, FL 33309

Re: k040670

> Trade/Device Name: TrueTrack Smart System Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: March 12, 2004 Received: March 15, 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. Iisting 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) I his letter will allow you to oegin marksmig your active equivalence of your device to a legally premarket notification. THC PDA miding of basistance vice and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, If you desire specific information about as a vertising of your device, please contact the Office of of questions on the promotion and Safety at [phone]. Also, please note the In Viro Diagnostic Device Evanation and Baroy as ( . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . You may obtain other general information on your responsibilities under the Act from the You may obtain other geleral mormation on 70 a responser 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, MS, DVM.

Yean 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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510(k) Number (if known):

K040670

Device Name: TrueTrack Smart System Blood Glucose Monitoring System

Indications For Use:

The TrueTrack Smart System Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Carol C. Benson
Division Sign-Off

A

Office of in Vitro Diagnostic Device Evaluation and Safety

510(K) K040670

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use (Oer 21 CFR 801.109) Over-The-Counter Use (Optional Format 1-2-96)