← Product Code [CDQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ) · K993178 # UREA-L3K ASSAY, CATALOGUE NUMBER 283-17/10/30/50 (K993178) _Diagnostic Chemicals , Ltd. · CDQ · Oct 18, 1999 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K993178 ## Device Facts - **Applicant:** Diagnostic Chemicals , Ltd. - **Product Code:** [CDQ](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ.md) - **Decision Date:** Oct 18, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1770 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use For the quantitative determination of urea in serum. For IN VITRO diagnostic use. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. ## Device Story Urea-L3K is an in vitro diagnostic assay for quantitative measurement of urea nitrogen in serum. Used in clinical laboratory settings by trained personnel. Input is patient serum sample; assay performs chemical reaction to measure urea nitrogen levels. Output is numerical concentration value used by clinicians to assess renal function and metabolic status. Results aid in diagnosis and management of renal/metabolic diseases. ## Technological Characteristics In vitro diagnostic reagent system for quantitative urea nitrogen measurement in serum. Class II device. Technical specifications and specific chemical methodology not detailed in provided text. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 image of three human profiles facing to the right, with flowing lines suggesting movement or connection. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 1 8 1999 Ms. Karen Callbeck, R.T. B.Sc. Regulatory Affairs Coordinator Diagnostics Chemicals Limited 16 McCarville Street Charlottetown, P.E.I., Canada Re: : K993178 Trade Name: Urea-L3K Assay Regulatory Class: II Product Code: CDQ Dated: September 21, 1999 Received: September 23, 1999 Dear Ms. Callbeck: 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 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). 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 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 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. {1}------------------------------------------------ ## Page 2 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 (770) 488-7655. 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrlv/dsma/dsmamain.html". Sincerely yours, Steven Sutman 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 {2}------------------------------------------------ 510(k) Number (if known): K 993178 Device Name: Urea-L3K ## Indications for Use: For the quantitative determination of urea in serum. For IN VITRO diagnostic use. A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases. tean Cooper (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K993178 (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109 OR ## Over-The-Counter Use (Optional Fennat 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K993178](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CDQ/K993178) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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