PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM

K992988 · Home Diagnostics, Inc. · CGA · Sep 24, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992988
• Device Name: PRESTIGE LX BLOOD GLUCOSE TEST SYSTEM
• Applicant: Home Diagnostics, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Sep 24, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Prestige LX Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Device Story

Prestige LX Blood Glucose Test System; in vitro diagnostic device for quantitative glucose measurement in human whole blood. Used by patients and healthcare professionals for diabetes management. System processes blood samples to provide glucose concentration readings. Assists in clinical decision-making regarding glycemic control. Operates as a point-of-care testing system.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic blood glucose monitoring system; quantitative measurement principle; intended for whole blood samples.

Indications for Use

Indicated for quantitative glucose determination in human whole blood to assist patients and healthcare professionals in diabetes management.

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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure with three horizontal lines above it, representing the concept of health and human services.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 4 1999

Ms. Karen DeVincent Director of Regulatory Affairs Home Diagnostics, Inc. 2400 N.W. 55th Court Fort Lauderdale, Florida 33309

Re: K992988

> Trade Name: Prestige LX Blood Glucose Test System Regulatory Class: II Product Code: CGA Dated: September 3, 1999 Received: September 3, 1999

Dear Ms. DeVincent:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may . require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Gutman

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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**Page** ***_*** of **_**

510(k) Number (if known): K992988

Prestige LX Blood Glucose Test System Device Name: _____

Indications For Use:

The Prestige LX Blood Glucose Test System is intended for the quantitative determination of glucose in human whole blood. The System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Dean Cooper

cevices sion of Clini 510(k) Numbe

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

OK

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use**
(Oer 21 CFR 801.109) ✓

Over-The-Counter Use

(Optional Format 1-2-96)