DBSET MULTIDRUG SCREEN TEST KIT by AMERITEK, INC.

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 Description

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AI/ML Overview

The provided document is a 510(k) clearance letter for the "dBest MultiDrug Screen Test Kit." This type of document declares substantial equivalence to a predicate device and does not typically include detailed acceptance criteria or a comprehensive study plan with the specific performance metrics you're requesting for a device like a diagnostic AI or imaging system.

The acceptance criteria and performance reported in this document are framed within the context of a drug screen test kit, which focuses on cut-off levels and qualitative detection.

Here's an attempt to answer your questions based on the limited information available in this 510(k) letter, interpreting the information in a way that aligns with your request where possible, and noting when the information is not present.

The dBest MultiDrug Screen Test Kit is a qualitative immunochromatographic assay for the rapid detection of specific drugs in urine.

1. Table of Acceptance Criteria and the Reported Device Performance:

Drug Tested	Acceptance Criteria (Cutoff)	Reported Device Performance (Qualitative Detection)
Amphetamines	1000 ng/ml	Qualitative detection in urine
Cocaine (Benzoylecgonine)	300 ng/ml	Qualitative detection in urine
Methamphetamines	1000 ng/ml	Qualitative detection in urine
Opiates	300 ng/ml	Qualitative detection in urine
Tetrahydrocannabinol	50 ng/ml	Qualitative detection in urine
Overall	Not specified for accuracy	Substantially equivalent to predicate devices

Note: The document lists the cutoff levels which serve as a form of acceptance criteria for a qualitative drug test. It doesn't report specific sensitivity, specificity, or accuracy percentages, as these would typically be detailed in the study report submitted to the FDA, not necessarily in the clearance letter itself.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in this document.
Data Provenance: Not specified in this document. Typically, drug screen test kits would involve clinical samples from human subjects. The document does not indicate retrospective or prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. For a qualitative drug test, ground truth is typically established by definitive analytical methods (e.g., GC/MS) rather than expert consensus on interpretation of the device's results.

4. Adjudication method for the test set:

Not applicable/Not specified. Adjudication methods are more commonly used in interpreting subjective findings (e.g., medical images) rather than the binary (positive/negative) output of a qualitative drug screen.

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. This device is a rapid diagnostic test kit, not an AI-powered diagnostic imaging or interpretation system. Therefore, MRMC studies and AI assistance metrics are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device itself is a standalone test kit; it performs the detection without human interpretation beyond reading the visual result (e.g., line appearance). However, this question typically refers to AI algorithms. In that context, it's not applicable.

7. The type of ground truth used:

While not explicitly stated in this document, for drug screen tests, the ground truth for establishing performance is typically definitive analytical methods (e.g., Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS)) to confirm the presence and concentration of the drug metabolites in the urine samples.

8. The sample size for the training set:

Not applicable or not specified. Immunochromatographic assays do not typically involve a "training set" in the machine learning sense. The device's performance is based on its chemical and biological design.

9. How the ground truth for the training set was established:

Not applicable. (See #8).

Summary

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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.

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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 (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

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Page of

510 (K) Number (if known): 990681

Device Name: dBest MultiDrug Screen Test Kits

Indications For Use:

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_

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

Regulation Number and Section

§ 862.3100 Amphetamine test system.

(a)
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.(b)
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).