← Product Code LCM · K043071 # RANDOX PHENCYCLIDINE ASSAY (K043071) _Randox Laboratories, Ltd. · LCM · Jan 27, 2005 · CH · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K043071 ## Device Facts - **Applicant:** Randox Laboratories, Ltd. - **Product Code:** LCM - **Decision Date:** Jan 27, 2005 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** CH ## Intended Use The evidence® Phencyclidine test has been designed for use only on the evidence® analyser for qualitative detection of phencyclidine in urine, using a cut-off concentration of 25 ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of phencyclidine use or overdose. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS) is the preferred method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Phencyclidine Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, opiates and phencyclidine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. ## Device Story The evidence® Phencyclidine Assay is an in vitro diagnostic test for qualitative detection of phencyclidine in urine samples; used exclusively on the evidence® analyser. The system processes urine samples to provide preliminary analytical results for clinical use in diagnosing phencyclidine use or overdose. Results are intended for professional use by qualified laboratory personnel in clinical settings. The device requires confirmation of positive results via alternative methods like GC/MS. The evidence® Drugs of Abuse Calibrators (9 levels) are liquid reagents containing various drugs of abuse used to calibrate the evidence® system. The assay aids healthcare providers by providing rapid preliminary screening, facilitating clinical decision-making regarding patient treatment for drug exposure. ## Clinical Evidence No clinical trials were performed. Performance was established via bench testing and method comparison. A study of 1,365 clinical urine samples showed 99% positive agreement and 98% negative agreement compared to the predicate. A secondary study of 144 samples compared to GC/MS showed 100% positive agreement. Precision studies (n=80 per concentration) demonstrated CVs ranging from 6.9% to 16.6%. Analytical specificity and interference testing were conducted for various compounds and endogenous substances. ## Technological Characteristics Solid-state Biochip array; competitive chemiluminescent immunoassay; polyclonal sheep antibodies; horseradish peroxidase (HRP) label; automated digital imaging detection; phosphate buffer-based calibrators; 25 ng/mL cutoff; requires Randox evidence® analyzer; software-based signal normalization; 1-year stability at 2-8°C. ## 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}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES 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" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus, with three curved lines representing the serpent and staff. JAN 2 7 2005 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Biochemical Manufacturers 55 Diamond Road Crumlin, Co. Antrim United Kingdom, BT29 4QY k043071 Re: > Trade/Device Name: evidence® Phencyclidine Assay evidence® Drugs of Abuse Calibrators Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: LCM, DKB Dated: November 5 2004 Received: November 8, 2004 Dear Dr. Armstrong: 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). {1}------------------------------------------------ #### Page 2 - 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 (240)276-0484. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely vours. Sean M. Cooper MS, DUM 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known): ## Device Name: evidence® DRUGS OF ABUSE CALIBRATORS ### Indications For Use: The evidence® Phencyclidine test has been designed for use only on the evidence® analyser for qualitative detection of phencyclidine in urine, using a cut-off concentration of 25 ng/ml. Qualitative results obtained can be utilised in the diagnosis and treatment of phencyclidine use or overdose. This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography / mass spectrometry (GC/MS) is the preferred method. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used. The Phencyclidine Assay must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. ### The evidence® Drugs of Abuse Calibrators. The evidence® Drugs of Abuse Calibrators are liquid Calibrators containing benzoylecgonine, amphetamine, methamphetamine, methadone, opiates and phencyclidine. There are 9 levels of calibrator. They have been developed for use in calibration of the evidence® system. The evidence® Drugs of Abuse Calibrators must only be used by suitably qualified laboratory personnel under appropriate laboratory conditions. Prescription Use (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) | Division Sign-Off | acting | |------------------------------------------------------------|---------| | Office of In Vitro Diagnostic Device Evaluation and Safety | | | 510(k) | K043071 | Page 1 of 1 --- **Source:** [https://fda.innolitics.com/device/K043071](https://fda.innolitics.com/device/K043071) **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