EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS

K021781 · Chay Medical, LLC · CGA · Aug 30, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021781
• Device Name: EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
• Applicant: Chay Medical, LLC
• Product Code: CGA · Clinical Chemistry
• Decision Date: Aug 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Excelsior 3ul blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX or Prestige IQ blood glucose meters. Excelsior 3ul test strips, when used with the aforementioned meters, will quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.

Device Story

Excelsior 3ul blood glucose test strips function as an in vitro diagnostic accessory for Home Diagnostics, Inc. Prestige LX and Prestige IQ blood glucose meters. Device utilizes fresh whole blood samples to quantitatively measure glucose levels. Intended for both professional clinical settings and home use by patients for diabetes management. Output is a numerical glucose concentration displayed on the compatible meter, providing essential data for clinical decision-making and patient self-monitoring of blood glucose levels.

Technological Characteristics

In vitro diagnostic test strip for quantitative glucose measurement. Designed for use with Prestige LX and Prestige IQ blood glucose meters. Class II device (21 CFR 862.1345, Product Code CGA).

Indications for Use

Indicated for professional and home use for the quantitative measurement of glucose in fresh whole blood to assist in the management 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.

Reference Devices

• Home Diagnostics, Inc. Prestige LX blood glucose system
• Home Diagnostics, Inc. Prestige IQ blood glucose system

Submission Summary (Full Text)

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Food and Drug Administration 098 Gaither Road Rockville MD 20850

Mr. Stephan C. Pearson Program Manager Chay Medical, LLC 66 Neptune Drive Groton, CT 06340

AUG 3 0 2002

Re: k021781

> Trade/Device Name: Excelsior 3ul blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX blood glucose system, and Prestige IQ blood glucose system.

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA Dated: July 31, 2002 Received: August 2, 2002

Dear Mr. Pearson:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device. please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Ko21781

Device Name: Excelsior 3ul blood glucose test strips for use with the Home Diagnostics, Inc. Prestige LX blood glucose system, and Prestige IQ blood glucose system.

Indications For Use:

The Excelsior 3ul blood glucose test strips are intended for both professional and home use when used with the Home Diagnostics, Inc. Prestige LX or Prestige IQ blood glucose meters. Excelsior 3ul test strips, when used with the aforementioned meters, will quantitatively measure glucose levels in fresh whole blood, which will provide the user essential information for the proper management of diabetes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Cooper

(Division Sign-Off)

Division of Clinical Va Devices 510(k) Number

Prescription Use

OR

Over-The-Counter Use

(PER 21 CFR 801.109)

(Optional Format 1-2-96)

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