← Product Code [DKB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB) · K974699 # REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN URINE (K974699) _Consolidated Technologies, Inc. · DKB · Jan 22, 1998 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K974699 ## Device Facts - **Applicant:** Consolidated Technologies, Inc. - **Product Code:** [DKB](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB.md) - **Decision Date:** Jan 22, 1998 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3200 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and metabolite in human urine. ## Device Story Device is a reference material used in clinical laboratory settings to verify accuracy of GC/MS (Gas Chromatography/Mass Spectrometry) analytical methods. It serves as a control or calibrator for quantifying amphetamine, methamphetamine, and their metabolites in human urine. Laboratory technicians or clinical chemists utilize the material to validate instrument performance and ensure reliable test results for drug screening or confirmation. By providing a known standard, the device assists in maintaining the precision and accuracy of diagnostic testing, ultimately supporting healthcare providers in making informed clinical decisions regarding patient drug status. ## Clinical Evidence No clinical data; bench testing only. ## Technological Characteristics Reference material for laboratory use; intended for GC/MS analytical verification. No specific materials, energy sources, or software algorithms described. ## Regulatory Identification A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.) ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. ## 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 stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JAN 2 2 1998 E. Kay Robinson Director of QC/Technical Service Consolidated Technologies, Inc. 2170 Woodward Street, Suite 100 Austin, Texas 78744-1832 Re: K974699 Reference Material for Amphetamine/Methamphetamine in Human Urine II Requlatory Class: Product Code: DKB October 20, 1997 Dated: December 16, 1997 Received: Dear Ms. Robinson: ----------------------------------------------------------------------------------------------------------------------------------------------------------- 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 reqistration, 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. 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 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 requlations. {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/cdrh/dsmamain.html". Sincerely yours, Steven Gutman 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}------------------------------------------------ Image /page/2/Picture/0 description: The image is a black and white photograph. The image shows a dark, round object in the lower center of the frame. The object appears to be suspended in the air, with a thin, dark line extending from its right side. The background is mostly white, with some dark areas in the upper left corner. ## Indication for Use Device Name: Reference Material for Amphetamine/Methamphetamine in Human Urine Indication for Use: Reference Material for Amphetamine/Methamphetamine in Human Urine is a material intended for use in verifying the accuracy of GC/MS methods used for quantitation of this analyte and imetabolite in human urine. prescription use aw 1-16 48 (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number 74699 3 દર പ് --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K974699](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/DKB/K974699) **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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