GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM

K971653 · Clinical Diagnostics, Inc. · CGA · Jan 2, 1998 · Clinical Chemistry

Device Facts

• Record ID: K971653
• Device Name: GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM
• Applicant: Clinical Diagnostics, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 2, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM is intended for the quantitative measurement of glucose in capillary whole blood.

Device Story

The Glucochek Pocketlab II Blood Glucose System is an in vitro diagnostic device designed for the quantitative measurement of glucose in capillary whole blood. It is intended for use by patients or healthcare professionals to monitor blood glucose levels. The system processes blood samples to provide a numerical glucose concentration output, which assists in the management of blood glucose levels. The device is used in clinical or home settings to facilitate clinical decision-making regarding diabetes management.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In vitro diagnostic blood glucose monitoring system; utilizes capillary whole blood samples; quantitative measurement principle; class II device.

Indications for Use

Indicated for the quantitative measurement of glucose in capillary whole blood for patients requiring blood glucose monitoring.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN - 2 1996

Rhonda P. Blanton Director, Requlatory Affairs Clinical Diagnostics, Inc. 609 Columbia Road Chester, South Carolina 29706

K971653 Re : Glucochek Pocketlab II Blood Glucose System Regulatory Class: II Product Code: CGA October 9, 1997 Dated: October 14, 1997 Received:

Dear Ms. Blanton:

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 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 The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 Also, please note the Office of Compliance at [phone]. 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/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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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

年紀年に行使者

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Over-The-Counter Use_

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