DBEST TETRAHYDROCANNABINOL TEST KIT by AMERITEK, INC.

dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only.

Device Description

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "dBest Tetrahydrocannabinol Test Kits." It determines the device's substantial equivalence to a predicate device. However, this document does not contain the detailed study results, acceptance criteria, or performance data that would typically be found in a device's submission or clinical study report.

Therefore, I cannot fully complete the requested table and information based solely on the provided text. The document is an FDA clearance letter, not a detailed technical report of a study.

Here's what I can extract and what I cannot:

What can be extracted:

Device Name: dBest Tetrahydrocannabinol Test Kits
Intended Use Statement: "dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only."
Regulatory information: This is a Class II device, Cleared via 510(k) K983188.

What cannot be extracted (as it's not present in the provided document):

Specific acceptance criteria (e.g., sensitivity, specificity thresholds).
Reported device performance values against acceptance criteria.
Details of the study that proves the device met acceptance criteria (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

Table of Acceptance Criteria and Reported Device Performance (Based on what should be there, but is not in the provided text):

Acceptance Criterion (Hypothetical, based on typical IVD performance)	Reported Device Performance (Not in document)
Sensitivity at 50 ng/mL cutoff (e.g., ≥95%)	Not reported in provided text
Specificity for THC metabolites (e.g., ≥95%)	Not reported in provided text
Interference from common substances (e.g., no cross-reactivity)	Not reported in provided text
Precision/Reproducibility (e.g., consistent results)	Not reported in provided text

Detailed Study Information (Not available in the provided document):

Sample size used for the test set and the data provenance: Not mentioned in the provided text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned in the provided text.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned in the provided text.
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. This is an immunochromatographic assay for THC, not an AI-assisted diagnostic imaging task that would typically involve human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device is a "one step immunochromatographic assay," implying it is a standalone test kit, not an algorithm. Performance would be assessed directly from the test result.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned in the provided text. For a drug test, the ground truth would typically be established by a more definitive laboratory method (e.g., GC/MS or LC/MS) on the same urine samples.
The sample size for the training set: Not applicable based on the nature of this device as a traditional immunochromatographic assay. There isn't an "algorithm" being trained in the typical AI sense.
How the ground truth for the training set was established: Not applicable for the same reason as point 7.

In summary, the provided document is a regulatory clearance letter and does not contain the detailed technical or clinical study data requested. To answer these questions, one would need access to the full 510(k) submission document or a summary of the performance data that supported this clearance.

Summary

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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 a human figure with three flowing lines extending upwards, possibly representing growth or progress.

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: K983188

Trade Name: dBest Tetrahydrocannabinol Test Kit Regulatory Class: II Product Code: LDJ 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 OS 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 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 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): K983188

Device Name: dBest Tetrahydrocannabinol Test Kits

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number R2983158

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDED)

Prescription Use

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

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).