MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM

K031843 · Medline Industries, Inc. · NBW · Jul 3, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031843
• Device Name: MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
• Applicant: Medline Industries, Inc.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Jul 3, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Evencare® Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. It is intended for use outside the body by diabetics at home and in clinical settings as an aid to monitor the effectiveness of diabetes control.

Device Story

EvenCare Blood Glucose Monitoring System measures glucose levels in fresh capillary whole blood samples. Device intended for use by diabetics in home or clinical settings to monitor diabetes control. System provides quantitative glucose concentration output to assist users and clinicians in managing diabetes. Operation involves applying blood sample to test strip for analysis by meter. Output allows for tracking glucose trends and adjusting therapy as needed.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Glucose test system (21 CFR 862.1345); quantitative measurement of capillary whole blood glucose; intended for in vitro diagnostic use.

Indications for Use

Indicated for quantitative glucose measurement in fresh capillary whole blood. Intended for use by diabetics in home and clinical settings to monitor diabetes control effectiveness.

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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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 eagle or bird-like symbol with three curved lines forming its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

C and Drug Administration 198 Gaither Road Rockville MD 20850

## JUL 0 3 2003

Ms. Andrea Haferkamp Corporate Director of Regulatory Affairs Medline Industries. Inc. One Medline Place Mudelein, IL 60060

Re: k031843 Trade/Device Name: EvenCare ® Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; CGA Dated: June 13, 2003 Received: June 16, 2003

Dear Ms. Haferkamp:

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 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): K03/843

Device Name: EvenCare® Blood Glucose Monitoring System

Indications for Use:

The Evencare® Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. It is intended for use outside the body by diabetics at home and in clinical settings as an aid to monitor the effectiveness of diabetes control.

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

510(k) K031843

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-the-Counter Use v Prescription Use (Per 21 CFR 801.109)

(Optional Format 12-96)