TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81

K080710 · Home Diagnostics, Inc. · NBW · Aug 13, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080710
• Device Name: TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81
• Applicant: Home Diagnostics, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The TRUE2go 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

TRUE2go Blood Glucose Monitoring System; portable device for quantitative glucose measurement in human whole blood. Input: capillary (home) or venous (professional) whole blood samples. Operation: electrochemical biosensor technology; converts glucose concentration in blood sample to electrical signal; displays numerical glucose value. Used by patients for self-monitoring or healthcare professionals in clinical settings. Output: blood glucose concentration; assists in diabetes management decisions. Device provides portable, point-of-care testing capability.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Electrochemical glucose test system; portable form factor; intended for capillary and venous whole blood analysis. Class II device (Product Codes: NBW, LFR).

Indications for Use

Indicated for quantitative glucose determination in human whole blood (finger/forearm capillary for patients; venous for healthcare professionals) to assist in diabetes management. Contraindicated for neonates, patients using medications containing or metabolizing to maltose, galactose, or xylose (e.g., peritoneal dialysis, immunoglobulin therapies), and critically ill patients (e.g., dehydrated, shock, hyperosmolar). Not for screening or diagnosis of diabetes.

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with its wings spread, positioned above a circular seal. The seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged around the perimeter.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 3 2008

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

Re: k080710 Trade Name: TRUE2go 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 4, 2008 Received: August 5, 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 1egally 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 tolloffram mber [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

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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510(k) Number (if known): K080710

Device Name: TRUE2go Blood Glucose Monitoring System

Indications for Use:

The TRUE2go 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 _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

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

Carol C. Benson

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

510(k) K080710