GLUCOLEADER VALUE

K023279 · Hmd Biomedical, Inc. · NBW · Aug 4, 2003 · Clinical Chemistry

Device Facts

• Record ID: K023279
• Device Name: GLUCOLEADER VALUE
• Applicant: Hmd Biomedical, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Aug 4, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Indications for Use

For the quantitative measurement of glucose levels in human whole blood. For use by persons with diabetes at home for monitoring and by health care workers in a professional setting.

Device Story

GlucoLeader™ Blood Glucose Test System measures glucose levels in human whole blood. System consists of a meter and test strips. User applies blood sample to test strip; meter performs electrochemical analysis to determine glucose concentration. Used by patients at home for self-monitoring and by healthcare professionals in clinical settings. Output is a numerical glucose value displayed on the meter screen. Provides real-time data to assist patients and clinicians in managing diabetes through glycemic control.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on bench testing and comparison to predicate technology.

Technological Characteristics

Electrochemical biosensor system; utilizes disposable test strips for whole blood glucose measurement. Meter-based digital display. Standalone device.

Indications for Use

Indicated for quantitative glucose measurement in human whole blood. Intended for home use by individuals with diabetes and for professional use by healthcare workers.

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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AUG - 4 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

HMD Biomedical, Inc. c/o Jeffrey Fleishman Immunostics, Inc. 3505 Sunset Avenue Ocean, New Jersey 07712

Re: k023279

> Trade/Device Name: HMD Biomedical GlucoLeader™ Blood Glucose Test System Regulation Number: 21 CFR § 862.1345 Regulation Name: System, Test, Blood Glucose, Over-the-Counter Regulatory Class: II Product Code: NBW, CGA Dated: May 2, 2003 Received: May 30, 2003

Dear Mr. Fleishman:

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). 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.

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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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director 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): K023279

HMD Biomedical's GlucoLeader™ Value Device Name:

Indications for Use: For the quantitative measurement of glucose levels in human multations for USe. For the qualifishing and by health care workers in a professional setting.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safet

510(k) K023279