BUN

K971967 · Carolina Liquid Chemistries Corp. · CDQ · Jun 17, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971967
• Device Name: BUN
• Applicant: Carolina Liquid Chemistries Corp.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Jun 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.

Device Story

BUN Reagent is an in vitro diagnostic reagent used for the quantitative measurement of urea nitrogen in serum samples. The device is designed for use on Beckman SYNCHRON CX Clinical Systems. It is intended for use in clinical laboratory settings by trained laboratory personnel. The reagent facilitates the biochemical analysis of serum to assist healthcare providers in diagnosing and monitoring renal and metabolic conditions. The output is a quantitative concentration of urea nitrogen, which informs clinical decision-making regarding patient kidney function and metabolic status.

Clinical Evidence

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

Technological Characteristics

In vitro diagnostic reagent for quantitative chemical analysis of serum urea nitrogen. Designed for use on automated clinical chemistry analyzers (Beckman SYNCHRON CX).

Indications for Use

Indicated for the quantitative determination of urea nitrogen in serum for the diagnosis and treatment of renal and metabolic diseases in patients requiring clinical laboratory testing.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN 17 1997

Cynthia Shuqart · President Carolina Liquid Chemistries Corporation 451 West Lambert Road, Suite 207 Brea, California 92821

- K971967 Re : BUN Reagent Requlatory Class: II Product Code: CDQ Dated: May 26, 1997 May 28, 1997 Received:
Dear Ms. Shugart:

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. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 requlations.

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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 requlation (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.qov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

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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K971967 510(k) Number (if known):

Device Name: Blood Urea Nitrogen (BUN) Reagent

Indications For Use:

BUN Reagent is intended for the quantitative determination of urea nitrogen in serum using Beckman SYNCHRON CX Clinical Systems. The results are used in the diagnosis and treatment of certain renal and metabolic diseases.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Veronica Calvin for Dr Montameus.f
(Division Sign-Off)
Division of Clinical Laborat
ces
510(k) Number 297961

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

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