(68 days)
dBest Methamphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of methamphetamines and its metabolites such as oxidized, deaminated and conjugated derivatives in urine. dBest Methamphetamines Test Kit is intended for professional and laboratory use only.
dBest Methamphetamines Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of methamphetamines and its metabolites such as oxidized, deaminated and conjugated derivatives in urine.
{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": "Not explicitly stated in the provided text.",
"Reported Device Performance": "Not explicitly stated in the provided text."
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "Not explicitly stated in the provided text.",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable, as this device is an in vitro diagnostic test for methamphetamine and not a medical imaging device requiring expert interpretation.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable, as this device is an in vitro diagnostic test for methamphetamine and not a medical imaging device requiring expert interpretation.",
"5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "Not applicable, as this device is an in vitro diagnostic test for methamphetamine and not an AI-assisted diagnostic tool.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "The device is described as a 'simple one step immunochromatographic assay', implying it functions as a standalone test without human-in-the-loop performance in its primary operation. However, no specific study details are provided.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not explicitly stated in the provided text. For an immunochromatographic assay, the ground truth would typically be established through confirmatory laboratory methods (e.g., GC/MS) on the same samples.",
"8. The sample size for the training set": "Not explicitly stated in the provided text.",
"9. How the ground truth for the training set was established": "Not explicitly stated in the provided text. For an immunochromatographic assay, the ground truth would typically be established through confirmatory laboratory methods (e.g., GC/MS) on the same samples."
}
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines beneath them.
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 (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 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 (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 at (301) 443-6597 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:
dBest Methamphetamines Test Kit is a simple one step immunochromatographic assay for dBest Methanphetamines Test Art is a seeps of the metabolites such as oxidized, a
rapid, qualitative detection of methamphetes and its methods on the mather matercaphetems rapid, qualifative dececion of methamplicallines and he he most methamphetamines dealimated delivery conversional and laboratory use only
| (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
OR
Over-The -Counter Use (Optional Format 1-2-96)_
.
:
§ 862.3610 Methamphetamine test system.
(a)
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.(b)
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).