← Product Code [DIC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC) · K993920 # ETHANOL-L3K ASSAY, CATALOGUE NUMBER 273-30, 273-17 (K993920) _Diagnostic Chemicals , Ltd. · DIC · Jan 18, 2000 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K993920 ## Device Facts - **Applicant:** Diagnostic Chemicals , Ltd. - **Product Code:** [DIC](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC.md) - **Decision Date:** Jan 18, 2000 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3040 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use. ## Device Story Ethanol-L3K is an in vitro diagnostic assay for quantitative ethanol measurement in serum. It utilizes an enzymatic procedure based on the Bonnichsen and Theorelle method; it eliminates the need for an aldehyde trap by employing a co-factor with high oxidizing potential. The assay is designed for rapid performance and is suitable for automation in clinical laboratory settings. By providing rapid ethanol quantification, the device assists clinicians in the differential diagnosis of comatose patients and supports medical-legal investigations regarding ethanol consumption or poisoning. ## Clinical Evidence No clinical data provided. The submission relies on the enzymatic methodology described in scientific literature (Bonnichsen and Theorelle) and bench-top validation of the assay's performance. ## Technological Characteristics Enzymatic assay for ethanol quantification. Utilizes a co-factor with high oxidizing potential to drive the reaction to completion without an aldehyde trap. Designed for automated clinical chemistry analyzers. ## Regulatory Identification An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning. ## 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it. The text is written in a simple, sans-serif font. Public Health Service JAN 18 2000 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Karen Callbeck, R.T. B.Sc. Regulatory Affairs Coordinator Diagnostic Chemicals Limited 16 McCarville Street West Royalty Industrial Park Charlottetown, P.E.I., Canada Re: K993920 Trade Name: Ethanol-L3K Assay, Catalogue Number 273-30, 273-17 Regulatory Class: II Product Code: DIC Dated: November 17, 1999 Received: November 18, 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 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" (21CFR 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/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman 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}------------------------------------------------ K993920 ## 510(k) Number (if known): _ Device Name: Ethanol-L3K, Cat. No. 273-30, 273-17 ## Indications for Use: For the quantitative determination of ethanol in serum. For IN VITRO diagnostic use. Ethanol (ethyl alcohol) is the most common toxic substance involved in medical-legal cases, Ethanol consumption is often a factor in all types of accidents and ethanol poisoning can be fatal. Ethanol testing of comatose patients aids in the differential diagnosis of the coma. (1) Early methods for ethanol analysis depended on separation of the ethanol from the specimen. The method described here is an enzymatic procedure which does not require separation and is rapid and easily automated. This method is based on the first enzymatic method described by Bonnichsen and Theorelle (2) and later modified by other authors. (3) However, the current method is unique in that an aldehyde trap is no longer necessary in order to drive the reaction to completion. This is accomplished by the use of a co-factor with a high oxidizing potential. (4) Sean Cooper Division Sign-Off vision of Clinical Laboratory Devices 9 91/10 510(k) Number (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 Format 1-2-96) . --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K993920](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DIC/K993920) **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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