DBEST METHAMPHETAMINES TEST KIT

K983189 · Ameritek, Inc. · LAF · Nov 18, 1998 · Clinical Toxicology

Device Facts

• Record ID: K983189
• Device Name: DBEST METHAMPHETAMINES TEST KIT
• Applicant: Ameritek, Inc.
• Product Code: LAF · Clinical Toxicology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3610
• Device Class: Class 2

Intended Use

dBest Methamphetamines Test Kit is a simple one step immunochromatographic assay for a rapid, qualitative detection of methamphetamines and its metabolites such as oxidized, and other methamphetamines in human urine. The test is for professional and laboratory use only.

Device Story

The dBest Methamphetamines Test Kit is an immunochromatographic assay designed for the rapid, qualitative detection of methamphetamines and their metabolites in human urine samples. The device is intended for professional and laboratory use. It functions as a one-step test, providing visual results to healthcare professionals or laboratory technicians. By identifying the presence of methamphetamine metabolites, the test assists in clinical decision-making regarding substance use screening. The device provides a simple, efficient method for point-of-care or laboratory-based drug testing, facilitating rapid assessment of patient samples.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunochromatographic assay; one-step test format; qualitative detection method; designed for human urine specimens.

Indications for Use

Indicated for the rapid, qualitative detection of methamphetamines and its metabolites in human urine. Intended for professional and laboratory use.

Regulatory Classification

Identification

A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

Special Controls

*Classification.* Class II (special controls). A methamphetamine 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)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## NOV 1 8 1998

Kuo Ching Yee, Ph.D. President AmeriTek, Inc. 7030 35th Avenue, NE Seattle, Washington 98115

Re: K983189

> Trade Name: dBest Methamphetamines Test Kit Regulatory Class: II Product Code: LAF Dated: September 10, 1998 Received: September 11, 1998

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 (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.

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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 [phone].

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 vour 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours.

Steven Sutman

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

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510 (K) Number (if known): K 983 / 8 9

Device Name: dBest Methamphetamines Test Kit

Indications For Use:

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| (Division Sign-Off) | |
|-----------------------------------------|-----------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | TC 983189 |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PA IF NEEDER)

Prescription Use

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Over-The -Counter Use (Optional Format 1-2-96)_

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