← Product Code [DKJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ) · K981872 # SALICYLATE-SL ASSAY CATALOGUE NUMBER 511-20,511-40 (K981872) _Diagnostic Chemicals , Ltd. · DKJ · Jun 29, 1998 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K981872 ## Device Facts - **Applicant:** Diagnostic Chemicals , Ltd. - **Product Code:** [DKJ](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ.md) - **Decision Date:** Jun 29, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3830 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use. ## Device Story Salicylate-SL Assay is an in vitro diagnostic reagent for quantitative measurement of salicylate in serum. It addresses clinical needs for rapid salicylate detection in cases of accidental ingestion or suicidal poisoning. Unlike traditional Trinder Reaction methods requiring extraction or centrifugation, this enzymatic assay uses salicylate hydroxylase to react with salicylate and NADH. The reaction causes a decrease in absorbance proportional to salicylate concentration. Designed for use on automated clinical laboratory instruments, it provides rapid, specific results to assist physicians in managing acute medical emergencies involving salicylate overdose, such as CNS disturbances, encephalopathy, and renal failure. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Enzymatic assay utilizing salicylate hydroxylase. Principle: decrease in NADH absorbance proportional to salicylate concentration. Form factor: liquid reagent for automated clinical chemistry analyzers. Intended for in vitro diagnostic use. ## Regulatory Identification A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy. ## 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/2 description: The image is a black and white seal for the Department of Health and Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH HUMAN SERVICES USA" around the edge. In the center of the seal is a stylized image of a person with their arms outstretched. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUN 7 9 1998 Karen Callbeck, R.T.B.Sc. . Regulatory Affairs Coordinator Diagnostic Chemicals Limited 16 First Street West Royalty Industrial Park Charlottetown, PE Canada C1E, 1B0 K981872 Re : Salicylate-SL Assay Requlatory Class: II Product Code: DKJ Dated: May 25, 1998 Received: May 28, 1998 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 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 The general controls provisions of the Act 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. ਸੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation 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 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 diaqnostic 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 "dsmo@fdadr.cdrh.fda.gov". Sincerely yours, Steven Autman 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): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Device Name: Salicylate-SL Assay _____________________________________________________________________________________________________________________________________________ ## Indications for Use: For the quantitative determination of salicylate in serum. For IN VITRO diagnostic use. Salicylate is a common drug used for its analgesic and anti-inflammatory properties. Its accessibility leads to its implication in a large number of accidental ingestions by children and it is a common choice among adults and adolescents for attempted suicidal poisoning. (1) Salicylate overdose results in disturbances of the central nervous system and the gastrointestinal tract as well as encephalopathy and renal failure. It represents an acute medical emergency and rapid quantitation of the drug is necessary for effective patient management. (2) Salicylate has been traditionally measured by the "Trinder Reaction" which is based on the interaction between salicylate and ferric ions. This test however is not specific and requires extraction or centrifugation which inhibit the automation of the test. This enzymatic Salicylate Assay provides a rapid, specific and simplified method for salicylate determination. It is based on the action of salicylate hydroxylase on salicylate and NADH which results in a decrease in absorbance proportional to the amount of salicylate present. (3) The test can be adapted to automated instruments resulting in rapid, accurate results required by physicians. Carol C Benson/R. Alfred Montgomery Division of Clinical Laboratory Devices 510(k) Number K981872 Prescription Use --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K981872](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKJ/K981872) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com