GLUCOSE REAGENT

K970664 · Derma Media Lab., Inc. · CFR · Aug 1, 1997 · Clinical Chemistry

Device Facts

• Record ID: K970664
• Device Name: GLUCOSE REAGENT
• Applicant: Derma Media Lab., Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

The Glucose Reagent is to be used to aid in the diagnosis of diabetes mellitus and other associated with glucose abnormalities.

Device Story

Glucose Reagent is an in vitro diagnostic chemical reagent used in clinical laboratory settings. It functions by reacting with patient serum or plasma samples to measure glucose concentration. The resulting colorimetric or enzymatic change is measured by a clinical chemistry analyzer, providing a quantitative glucose value. Healthcare professionals use these results to assess glycemic status, diagnose diabetes mellitus, and monitor glucose-related metabolic abnormalities. The device assists clinicians in making diagnostic and therapeutic decisions regarding patient glucose management.

Clinical Evidence

No clinical data provided; device is a standard in vitro diagnostic reagent.

Technological Characteristics

In vitro diagnostic chemical reagent for glucose quantification. Operates via standard clinical chemistry analytical methods. Intended for professional use in clinical laboratory environments.

Indications for Use

Indicated for use as an aid in the diagnosis of diabetes mellitus and other conditions associated with glucose abnormalities in patients requiring clinical glucose testing.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Charles C. Allain, Ph.D.
Director
Derma Media Lab, Inc.
7245 Garden Grove Boulevard, Suite E
Garden Grove, California 92641

Re: K970664
Glucose Reagent
Regulatory Class: II
Product Code: CFR
Dated: May 19, 1997
Received: May 22, 1997

Dear Dr. Allain:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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.

AUG - 1 1997

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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 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):

Device Name: Glucose Reagent

Indications For Use:

The Glucose Reagent is to be used to aid in the diagnosis of diabetes mellitus and other associated with glucose abnormalities.


Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use