TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81

K080641 · Home Diagnostics, Inc. · NBW · Aug 19, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080641
• Device Name: TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81
• Applicant: Home Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRUEresult Blood Glucose 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. Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing. Not for neonatal use.

Device Story

TRUEresult Blood Glucose Monitoring System measures glucose levels in human whole blood samples. Device utilizes electrochemical biosensor technology to quantify glucose concentration. Intended for use by patients at home (capillary blood) and healthcare professionals in clinical settings (venous/capillary blood). System provides digital glucose concentration readout to assist in diabetes management. Results enable patients and clinicians to monitor glycemic control and adjust therapeutic interventions accordingly. Not for neonatal use.

Clinical Evidence

No clinical data provided in the document; substantial equivalence established via regulatory review of device specifications and intended use.

Technological Characteristics

Electrochemical glucose test system. Measures glucose in whole blood. Form factor: handheld meter. Connectivity: not specified. Sterilization: not specified. Software: embedded firmware for signal processing and glucose calculation.

Indications for Use

Indicated for quantitative glucose determination in human whole blood (finger/forearm capillary for home use; venous for healthcare professionals) to assist in diabetes management. Contraindicated for neonatal 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

AUG 1 9 2008

Re: k080641

> Trade/Device Name: TRUEresult Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system. Regulatory Class: Class II Product Codes: NBW, LFR Dated: August 11, 2008 Received: August 13, 2008

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Yean 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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510(k) Number (if known): K080641

Device Name: TRUEresult Blood Glucose Monitoring System

Indications for Use:

The TRUEresult Blood Glucose 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.

Healthcare Professionals may use the device to test venous whole blood; home-use is limited to capillary whole blood testing.

Not for neonatal use.

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 OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVID)

Carol Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

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