"Rapid Drug Screen" 3-Panel Test for Cocaine, THC and Opiates is a one-step, lateral flow immunoassay for the simultaneous detection in urine of three abused drugs at stated detectable limits. (Each assay occupies a separate channel). It is intended for use in the qualitative detection of Cocaine (Benzoyl ecgonine), 300 ng/ml, THC (Cannabinoids), 50 ng/ml) and Opiates, 300 ng/ml.

"Rapid Drug Screen" is intended for professional use. It is not intended for over the counter sale to non-professionals. The assays are easy to perform, but should not be used without proper supervision. These immuno-assays are simplified qualitative screening methods that provide only a preliminary result for use in the need for additional or confirmatory testing, i.e., gas-chromatography/mass spectrometry (GC/MS).

"Rapid Drug Screen" provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a more confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

"Rapid Drug Screen" is not intended for use as a Point of Care test.

Device Description

All of the assays employed in the Rapid Drug Screen panels are based on the same principle of highly specific reaction between antigens and antibodies.

Each assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug which may be present in the sample for the limited number of binding sites on the antibody. The test device consists of a membrane strip onto which a drug conjugate has been immobilized. A colloidal gold-antibody complex is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the "test" area. The formation of a visible line in the test area occurs when the test is below the cut-off for the drug.

When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled antibody complex.. If sufficient amount of drug is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a color band (line) in the test area is indicative of a positive result.

A control band (line), comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of drug in the urine, and therefore, should be present in all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

AI/ML Overview

Here's an analysis of the provided text regarding the Rapid Drug Screen 3-Panel Test for Cocaine, THC, and Opiates, focusing on acceptance criteria and study information:

Description of Acceptance Criteria and Proving Device Performance

The provided document describes a reproducibility study as the primary method used to demonstrate the device's performance against its claimed detection levels (acceptance criteria). The study aimed to show that the device consistently produces the expected results (positive for drug presence above the cut-off, negative below) when tested multiple times.

1. Table of Acceptance Criteria and Reported Device Performance:

Analyte	Acceptance Criteria (Detection Level / Cut-off)	Reported Device Performance (Reproducibility Study)
Benzoyl ecgonine	300 ng/ml	Confirmed reproducibility using control urines above and below cut-off, and negative controls.
THC (Cannabinoids)	50 ng/ml	Confirmed reproducibility using control urines above and below cut-off, and negative controls.
Opiates	300 ng/ml	Confirmed reproducibility using control urines above and below cut-off, and negative controls.

Note: The document states "The results confirmed the reproducibility of the Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates." but does not provide specific metrics like sensitivity, specificity, accuracy, or concordance rates from this reproducibility study. It only confirms that the reproducibility was demonstrated.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: Each sample was tested four times, twice daily, for five days. The exact number of "control urines" used (i.e., distinct samples at specific concentrations) is not explicitly stated. It's implied there were samples above, below, and negative for each analyte. If we assume at least one unique sample for each category (above, below, negative) for each of the 3 analytes, that would be 9 initial control urine samples, each tested 20 times (4 times/day * 5 days).
Data Provenance: Not explicitly stated. The document doesn't mention the country of origin of the control urines or if they were clinical samples. It uses the term "control urines," suggesting they were prepared samples with known concentrations. The study is presented as evidence for the premarket notification (510(k)), implying it was conducted as part of the device's development/validation. It would be considered a prospective study in the sense it was designed for this validation purpose.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

Experts: Not applicable for establishing the ground truth of the test set itself.
Qualifications: The ground truth for the test set (control urines) was established through GC/MS (gas chromatography/mass spectrometry), which is a highly accurate analytical method, not by expert interpretation.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The "ground truth" for the control urines was established by GC/MS, an objective chemical analysis. The device's results were then compared against these GC/MS verified concentrations to assess reproducibility. There was no human expert adjudication of the test results themselves.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not done. This device is an in-vitro diagnostic (IVD) immunoassay, not an imaging or diagnostic AI system requiring human interpretation or MRMC studies comparing human readers with and without AI assistance. The performance described relates to the accuracy of the assay itself.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

Yes, this is a standalone performance study. The device itself (the immunoassay strip) provides a visual result (presence or absence of a line). The reproducibility study evaluates the device's ability to consistently produce this visual result based on known drug concentrations, without direct human intervention affecting the reading mechanism itself. The output is a clear visual signal (line or no line) that a human then interprets as positive or negative.

7. Type of Ground Truth Used:

Analytic Ground Truth: The ground truth for the control urine samples was established by Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "All concentrations were verified by GC/MS." GC/MS is considered the gold standard for confirming drug presence and concentration in urine.

8. Sample Size for the Training Set:

Not applicable. This document describes the validation of a lateral flow immunoassay, which is a pre-designed chemical reaction on a strip. It does not involve machine learning or AI models that require a "training set" in the conventional sense. The "training" of the device is inherent in its chemical design and manufacturing process, optimized to react at specific cut-off levels.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As stated above, there is no "training set" in the context of an AI/ML model for this type of device. The development of the device (e.g., antibody selection, conjugate immobilization) would have involved extensive R&D and optimization based on known drug concentrations and chemical principles to achieve the desired cut-offs. The "ground truth" during this development phase would have been lab-prepared samples with known concentrations, verified by analytical methods like GC/MS.

Summary

{0}------------------------------------------------

JAN 2 4 2000

American Bio Medica Corporation Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates

510(k) Summary

Submitter's Name/Address:	Contact Person:
American Bio Medica Corporation	Henry J. Wells
122 Smith Road	Vice President of Product
Kinderhook, N.Y. 12106	Development
	Phone: 800-227-1243
	Fax: 518-822-0391
Date of Preparation of this Summary:	November 1999
Device Trade or Proprietary Name:	Rapid Drug Screen 3-Panel Testfor CTO
Device Common/Usual Name orClassification Name:	Rapid Drug Screen 3-Panel forfor Cocaine, Marijuana(THC) (Cannabinoids) andOpiates
Classification Number/Class:	[no classification number]/Class I

This 510(k) Summary is being submitted in accordance with the requirements of 21 CFR 807.92.

14993961 The assigned 510(k) is:

Predicate Device: American Bio Medica "Rapid Drug Screen" 5-Panel Test Kit with Methamphetamine (K-984525).

Test Description:

All of the assays employed in the Rapid Drug Screen panels are based on the same principle of highly specific reaction between antigens and antibodies.

{1}------------------------------------------------

American Bio Medica Corporation Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates

A negative urine will produce two colored bands, and a positive sample will produce only one band.

Intended Use:

The Rapid Drug Screen 3-Panel test for CTO is used for the qualitative detection of the following abused substances in human urine: Cocaine (Benzoyl ecgonine), THC (Cannabinoids) and Opiates. This immunoassay is a simplified qualitative screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas chromatography/mass spectrometry (GC/MS).

Performance Characteristics:

This Rapid Drug Screen 3-Panel test will detect drugs of abuse in human urine at the following levels:

Benzoyl ecgonine	300 ng/ml
THC (Cannabinoids)	50 ng/ml
Opiates	300 ng/ml

Reproducibility was evaluated using control urines containing concentrations above and below the stated cut-off. Negative controls were also used. All concentrations were verified by GC/MS. Each sample was tested four times, twice daily, for five days. The results confirmed the reproducibility of the Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates.

{2}------------------------------------------------

American Bio Medica Corporation Rapid Drug Screen 3-Panel Test for Cocaine, THC and Opiates

Conclusion:

The Rapid Drug Screen 3-Panel for CTO is substantially equivalent to the Rapid Drug Screen 5-Panel with Methamphetamines demonstrated by results obtained in the studies. The three analytes in the kit have been cleared by the 510(k) process (K-984525). There is no evidence of cross-reactivity when the three colloidal gold-antibody complexes are mounted in a common device side-by-side with physical separation of the individual channels.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The caduceus is a common symbol for healthcare and medicine, and the text identifies the organization as a U.S. government agency.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 4 2000

Mr. Henry Wells Vice President, Product Development American Bio Medica Corporation 300 Fairview Avenue Hudson, New York 12534

Re: K993961

Trade Name: Rapid Drug Screen 3-Panel Test for Cocaine, THC, and Opiates Regulatory Class: II Product Code: LDJ, DIO, DJG Dated: November 15, 1999 Received: November 22, 1999

Dear Mr. Wells:

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.

{4}------------------------------------------------

Page 2

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" (21CFR 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 Butman

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

{5}------------------------------------------------

510(k) Number (if known)

K 993961

Device Name: Rapid Drug Screen 3-Panel Test for Cocaine, THC, and Opiates

Indications For Use:

"Rapid Drug Screen" is not intended for use as a Point of Care test.

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

	Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division Sign-Off) Division of Clinical Laboratory Devices
510(k) Number	K993961

Prescription Use(Per 21 CFR 801.109)	OR	Over-The-Counter Use
------------------------------------------	----	----------------------

(Optional Formal 1-2

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).