GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)

K980026 · Trace America, Inc. · CFR · Mar 10, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980026
• Device Name: GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
• Applicant: Trace America, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Mar 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Intended for the In Vitro, quantitative determination of Glucose in human serum, plasma urine. This "Glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis andtreatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma". CFR862.1345

Device Story

In vitro diagnostic test system for quantitative glucose determination in human serum, plasma, and urine. Utilizes hexokinase (HK) enzymatic method incorporating dynamic stabilization technology. Used in clinical laboratory settings by trained personnel. Provides quantitative glucose concentration values to clinicians to assist in diagnosing and monitoring carbohydrate metabolism disorders, including diabetes mellitus and hypoglycemia. Results inform clinical decision-making regarding patient metabolic status and treatment efficacy.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance and intended use characteristics.

Technological Characteristics

In vitro diagnostic reagent system using hexokinase (HK) enzymatic assay. Incorporates dynamic stabilization technology for reagent stability. Designed for quantitative analysis of glucose in serum, plasma, and urine. Class II device.

Indications for Use

Indicated for quantitative glucose measurement in human serum, plasma, and urine to aid in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

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

MAR 10 1998

David Johnston TAI Technical Director TRACE America, Inc. 7260 Northwest 58th Street Miami, Florida 33166

Re : K980026 Glucose (HK) Incorporating Dynamic Stabilization Technology Requlatory Class: II Product Code: CFR Dated: December 6, 1997 Received: January 5, 1998

Dear Mr. Johnston:

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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, -- 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/dsmamain.html".

Sincerely yours,
Steven Ditman

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 __ 1___ of ___ 1_________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): Device Name: Indications for Use:

Intended for the In Vitro, quantitative determination of Glucose in human serum, plasma urine.

This "Glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis andtreatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma". CFR862.1345

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) ✓

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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