UREA

K971309 · Derma Media Lab., Inc. · CDQ · Aug 1, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971309
• Device Name: UREA
• Applicant: Derma Media Lab., Inc.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Aug 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

The UREA reagent (BUN) is to be used to aid in the determination of liver and kidney functions and congestive heart failure and other diseases associated with protein catabolism.

Device Story

The UREA reagent (BUN) is an in vitro diagnostic chemical reagent used to measure urea nitrogen levels in patient samples. It assists clinicians in assessing liver and kidney function, diagnosing congestive heart failure, and monitoring conditions related to protein catabolism. The device is intended for prescription use in clinical laboratory settings. Healthcare providers use the quantitative results to inform clinical decision-making regarding patient metabolic status and organ function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagent for urea nitrogen (BUN) determination. Class II device (Product Code: CDQ).

Indications for Use

Indicated for use as an aid in the determination of liver and kidney functions, congestive heart failure, and other diseases associated with protein catabolism.

Regulatory Classification

Identification

A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

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

AUG - 1 1997

Re: K971309
UREA
Regulatory Class: II
Product Code: CDQ
Dated: May 22, 1997
Received: May 28, 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.

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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: UREA

Indications For Use:

The UREA reagent (BUN) is to be used to aid in the determination of liver and kidney functions and congestive heart failure and other diseases associated with protein catabolism.


Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use