RAICHEM BUN RATE REAGENT (LIQUID)

K041051 · Hemagen Diagnostics, Inc. · CDQ · Jun 30, 2004 · Clinical Chemistry

Device Facts

• Record ID: K041051
• Device Name: RAICHEM BUN RATE REAGENT (LIQUID)
• Applicant: Hemagen Diagnostics, Inc.
• Product Code: CDQ · Clinical Chemistry
• Decision Date: Jun 30, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This urea nitrogen test system is a device intended to measure urea nitrogen (an endproduct of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The intended patient population may be adult, pediatric, and neonatal.

Device Story

Liquid, ready-to-use enzymatic reagent for quantitative urea nitrogen measurement; utilizes Roche COBAS Mira Chemistry System. Principle: two-step enzymatic reaction; urea hydrolyzed by urease to ammonia and CO2; glutamate dehydrogenase catalyzes reaction of alpha-ketoglutarate and ammonia; NADH oxidized to NAD; decrease in absorbance measured at 340 nm. Used in clinical laboratory settings by trained personnel. Output: urea nitrogen concentration (mg/dL). Results assist clinicians in diagnosing and monitoring renal and metabolic disease states.

Clinical Evidence

No clinical data. Bench testing only. Method comparison study (n=101 serum samples) against predicate device showed slope 0.983, intercept 0.41, R² 0.999. Precision studies (n=20) showed total imprecision CV of 3.4% (normal) and 3.2% (abnormal). Linearity confirmed up to 80 mg/dL (114 mg/dL with auto-dilute). Detection limit 0.92 mg/dL. Interference testing (hemoglobin, bilirubin, triglycerides, EDTA, heparin) showed <10% variance.

Technological Characteristics

Liquid enzymatic reagent containing alpha-ketoglutarate, NADH, urease, glutamate dehydrogenase, buffers, stabilizers. Sensing principle: UV spectrophotometry (absorbance decrease at 340 nm). Designed for use on Roche COBAS Mira Chemistry System. Storage: 2-8°C. Standards referenced: NCCLS EP5-A (precision), EP6-A (linearity), EP7-A (interference), EP9-A (method comparison).

Indications for Use

Indicated for quantitative in vitro enzymatic determination of urea nitrogen in serum or plasma for adult, pediatric, and neonatal populations to aid in diagnosis and treatment of renal and metabolic diseases.

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

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 3 0 2004

Mr. James J. Miller Official Correspondent Hemagen Diagnostics, Inc. Raichem Division 9033 Red Branch Road Columbia, MD 21045

k041051 Re:

Trade/Device Name: Urea Nitrogen (BUN) test system Regulation Number: 21 CFR 862.1770 Regulation Name: Urea nitrogen test system Regulatory Class: Class II Product Code: CDQ Dated: April 7, 2004 Received: April 19, 2004

Dear Mr. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jain M. Cooper, US, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K041051

Device Name: Urea Nitrogen (BUN) test system

Indications For Use:

This reaqent is for the quantitative in vitro enzymatic determination of urea nitrogen in serum or plasma by measurement of the initial rate of reaction.

This urea nitrogen test system is a device intended to measure urea nitrogen (an endproduct of nitrogen metabolism) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. The intended patient population may be adult, pediatric, and neonatal.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol C. Benson
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K041051

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