TRACKRECORD DATA MANAGEMENT SOFTWARE

K070593 · Home Diagnostics, Inc. · NBW · May 7, 2007 · Clinical Chemistry

Device Facts

• Record ID: K070593
• Device Name: TRACKRECORD DATA MANAGEMENT SOFTWARE
• Applicant: Home Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: May 7, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

TrackRecord Data Management Software is intended for use in the home or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.

Device Story

TrackRecord Data Management Software functions as a data management tool for diabetes care. It accepts historical blood glucose test results as input; processes and organizes this data to facilitate review and evaluation; and produces reports or displays for patients and healthcare professionals. Used in home or clinical settings by patients or clinicians. Output assists in diabetes management decision-making by providing a structured view of historical glucose trends.

Clinical Evidence

No clinical diagnostic data; bench testing only. A Human Factors Study with 101 subjects (home users and healthcare professionals) evaluated design, ease-of-use, and instruction comprehension. Subjects performed 21 feature/function tests across five categories (Installation, UI, Setup, Downloading, Patient Management). Performance was rated by observers and reviewed by an expert panel. Results confirmed users could successfully install the software, upload data, and generate accurate reports.

Technological Characteristics

Software-based data management system for blood glucose test results. Operates as a standalone application for review and analysis of historical data. No specific hardware materials or energy sources defined as it is a software-only device.

Indications for Use

Indicated for people with diabetes and their healthcare professionals to review, analyze, and evaluate historical blood glucose test results for diabetes management. Suitable for home or clinical settings, single or multi-patient use.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY - 7 2007

Home Diagnostics, Inc. c/o Ms. Karen DeVincent Regulatory Affairs, Quality Assurance 2400 N.W. 55th Court Fort Lauderdale, F1 33309

k070593 Re:

> Trade/Device Name: Track Record Data Management Software Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, JQP Dated: February 28, 2007 Received: March 02, 2007

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 1 legal/y marketed predicate device results in a classification for your device and thus, perroits 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 tollofren mber [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Jean M. Cooper, M.S., 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

16070593 510(k) Number (if known):_

Device Name:

Indications For Use:

TrackRecord Data Management Software is intended for use in the home or in clinical settings, for single or multi-patient use, to assist people with diabetes as well as their healthcare professionals in the review, analysis and evaluation of historical blood glucose test results to support effective diabetes management.

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)

Sign-Off

In Vitro **Diagnostic Device**
and Safety

1070593

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