UREA NITROGEN (BUN) LIQUID REAGENT

K981106 · Teco Diagnostics · CDQ · Apr 16, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981106
• Device Name: UREA NITROGEN (BUN) LIQUID REAGENT
• Applicant: Teco Diagnostics
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Apr 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2

Intended Use

For the Kinetic Quantitative determination of Urea Nitrogen (MUN) in serum. Urea Nitrogen determination is an indicator of liver and kidney functions, such as; Mephritis, Acute Liver Destruction and Urinary Obstruction.

Device Story

Device is a liquid reagent set for kinetic quantitative determination of urea nitrogen (BUN) in serum samples. Used in clinical laboratory settings by trained personnel. Principle of operation involves kinetic chemical reaction to measure urea nitrogen levels. Output is a quantitative concentration value used by clinicians to evaluate liver and kidney function, aiding in diagnosis of conditions like nephritis, acute liver destruction, and urinary obstruction.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid reagent set for kinetic assay. In vitro diagnostic device. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the kinetic quantitative determination of urea nitrogen in serum to assess liver and kidney function, including conditions such as nephritis, acute liver destruction, and urinary obstruction.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 16 1998

Rhoda Filipina . Official FDA Correspondent Teco Diagnostics 4925 E. Hunter Avenue Anaheim, California 92807

Re: K981106 Urea Nitrogen (BUN) Liquid Reagent Set Requlatory Class: II Product Code: CDQ Dated: March 18, 1998 Received: March 26, 1998

Dear Ms. Filipina:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral 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, 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 In addition, FDA may publish further announcements action. 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 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 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 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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510(k) Number (if known):_ Urea Nitrogen (BUN) Liquid Reagent - Kinetic Method Device Name: Indications For Use:

For the Kinetic Quantitative determination of Urea Nitrogen (MUN) in serum. Urea Nitrogen determination is an indicator of liver and kidney functions, such as; Mephritis, Acute Liver Destruction and Urinary Obstruction.

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

Concurrence of CDRH, Office of Device Evaiuation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

(Optional Format 1-2-96)

Over-The-Counter Use

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(Division Sign-Off)
Division of Climcal Laboratory Devices,
510(k) Number K981106