← Product Code [DKZ](/productcode/DKZ) · K990681 # DBSET MULTIDRUG SCREEN TEST KIT (K990681) _Ameritek, Inc. · DKZ · Jul 15, 1999 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K990681 ## Device Facts - **Applicant:** Ameritek, Inc. - **Product Code:** [DKZ](/productcode/DKZ.md) - **Decision Date:** Jul 15, 1999 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3100 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## Indications for Use dBest MultiDrug Screen Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml, cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml, methamphetamines and its metabolites such as oxidized, deaminated derivatives in urine with cutoff of 1000 ng/ml, opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml and tetrahydrocannabinol and its metabolites 11-nor- 9tetrahydrocannabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest MultiDrug Screen Test Kits are for professional and laboratory use only. ## Device Story dBest MultiDrug Screen Test Kit is a lateral flow immunochromatographic assay for urine drug screening. Device detects amphetamines (1000 ng/ml), cocaine/benzoylecgonine (300 ng/ml), methamphetamines (1000 ng/ml), opiates (300 ng/ml), and THC metabolites (50 ng/ml). Intended for professional and laboratory use. Principle of operation involves competitive binding between drug in urine sample and drug-conjugate immobilized on membrane; presence of drug prevents color development at test line. Results are visually interpreted by healthcare professionals or laboratory technicians. Provides rapid qualitative screening to assist in clinical decision-making regarding substance use. ## Clinical Evidence No clinical data provided. The submission relies on bench testing for analytical performance (qualitative detection at specified cutoff concentrations) to establish substantial equivalence. ## Technological Characteristics Immunochromatographic lateral flow assay. Qualitative, visual readout. Analyte-specific antibodies immobilized on nitrocellulose membrane. Competitive binding format. Standalone test kit for professional/laboratory use. ## Regulatory Identification An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy. ## Special Controls *Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military). ## 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 an eagle or bird-like figure with three parallel lines extending from its head, resembling feathers or wings. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 JUL 15 1999 K.C. Yee, M.D., Ph.D. President AmeriTek, Inc. 7030 35th AVE NE Seattle, Washington 98115 Re: K990681 > Trade Name: dBest MultiDrug Screen Test Kit Regulatory Class: II Product Code(s): DKZ, LAF, DIO, DJG, LDJ Dated: April 20, 1999 Received: April 23, 1999 Dear Dr. Yee: 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 (OS) 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/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Putman 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}------------------------------------------------ Page of 510 (K) Number (if known): 990681 Device Name: dBest MultiDrug Screen Test Kits Indications For Use: dBest MultiDrug Screen Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of amphetamines in urine with cutoff of 1000 ng/ml, cocaine and primarily benzoylecgonine as metabolites in urine with cutoff of 300 ng/ml, methamphetamines and its metabolites such as oxidized, deaminated derivatives in urine with cutoff of 1000 ng/ml, opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml and tetrahydrocannabinol and its metabolites 11-nor- 9tetrahydrocannabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest MultiDrug Screen Test Kits are for professional and laboratory use only. Aean login Trision Sign-Off) Division of Clinical Laboratory 510(k) Number __ ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDEN) Prescription Use_ OR Over-The -Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda-staging.innolitics.com/device/K990681](https://fda-staging.innolitics.com/device/K990681) **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