GLUCOSE (HEXOKINASE)

K011900 · Jas Diagnostics, Inc. · CFR · Jul 31, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011900
• Device Name: GLUCOSE (HEXOKINASE)
• Applicant: Jas Diagnostics, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jul 31, 2001
• 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 on automated chemistry analyzers. 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.

Device Story

The Glucose Reagent is an in vitro diagnostic reagent used for the quantitative measurement of glucose in human serum. It is designed for use on automated chemistry analyzers in clinical laboratory settings. The reagent reacts with glucose in the serum sample to produce a measurable signal, typically via spectrophotometric analysis, which is then quantified by the analyzer. Healthcare providers use these glucose measurements to diagnose and monitor carbohydrate metabolism disorders, such as diabetes mellitus and various forms of hypoglycemia. The device assists clinicians in clinical decision-making regarding patient metabolic health and treatment efficacy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent for glucose determination. Designed for use on automated chemistry analyzers. Class II device, product code CGA. Regulation 862.1345.

Indications for Use

Indicated for the quantitative determination of glucose in human serum for 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

JUL 3 1 2001

Mr. David Johnston Technical Director JAS Diagnostics, Inc. 7220 N.W. 58th Street Miami, FL 33166

510(k) Number: K011900 Re: Trade/Device Name: Glucose Reagent Regulation Number: 862.1345 Regulatory Class: II Product Code: CGA Dated: May 21, 2001 Received: June 18, 2001

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 to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amerate of mixes 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 the Echarate 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 ( Femanet I ripps of ally of the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing A substantally cquiralism (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such perioure GMP mith the GMP regulation may result in 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 reemer 1 rease wou 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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This letter will allow you to begin marketing your device as described in your 510K) prematket This letter will allow you to begin manculig your do not of your device to a legally marketed
notification. The FDA finding of substantial equivale normits your device to notification. The FDA Inding of substantial equivaliation of the spermits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF) Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the office of additionally 809.10 for in vide diagnostions on the promotion and advertising of your device, [phone]. Additionally, for questions on [phone]. Also, please note the regulation please contact the Office of Compitation at (301) 3 + Tesals of (21CFR 807.97). Other general entitled, "Misbranding by telefice to premanted in the Act may be obtained from the Division of Small
information on your responsibilities under the Act 2011 443 6507 or stit information on your responsibilities must and 11 [phone] or [phone] or at its
Manufacturers Assistance at its toll-free number [phone] or [phone] Manufacturers 7135156af100 av 1da.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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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K011900

## JUL 3 1 2001

Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ N/A Device Name: __ Glucose REAGENT Indications for Use:

Intended for the In Vitro, quantitative determination of glucose in human serum on automated chemistry analyzers.

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.

Fred Lacy

(vision Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K011900

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use __

(Optional Format 1-2-96)