"Rapid Drug Screen" 5-panel with cocaine, marijuana, opiates, amphetamine and methamphetamine is a lateral flow immunoassay for the simulatenous detection in urine of five abused drugs at stated detectable limits. (Each assay occupies a seperate channel). It is intended for use in the qualitative detection of d-Amphetamine (1000 ne/ml). Benzoyl ecgonine (300 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 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 qualatative screening methods that provides only a preliminary result for use in the need for aditional 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 judgement should be applied to any drug of abuse test result, particulary when preliminary positive results are used.

"Rapid Drug Screen" is not intended 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 510(k) summary for the American Bio Medica Corporation Rapid Drug Screen 5-Panel Test with Methamphetamine, structured to answer your questions:

Acceptance Criteria and Device Performance Study for American Bio Medica Corporation Rapid Drug Screen 5-Panel Test with Methamphetamine (K993796)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are defined by its ability to qualitatively detect specific drugs of abuse in human urine at or above established cut-off concentrations. The reported device performance is described as successful reproducibility around these cut-off levels.

Drug	Acceptance Criteria (Cut-off Concentration)	Reported Device Performance (Reproducibility)
d-Amphetamine	1000 ng/ml	Confirmed (using control urines above and below cut-off, verified by GC/MS)
Benzoyl ecgonine	300 ng/ml	Confirmed (using control urines above and below cut-off, verified by GC/MS)
Cannabinoids	50 ng/ml	Confirmed (using control urines above and below cut-off, verified by GC/MS)
Methamphetamines	1000 ng/ml	Confirmed (using control urines above and below cut-off, verified by GC/MS)
Opiates	300 ng/ml	Confirmed (using control urines above and below cut-off, verified by GC/MS)

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

Sample Size for Test Set: Each sample (control urine above, below, and at cut-off, and negative controls) was tested four times, twice daily, for five days. The total number of individual samples tested is not explicitly stated. However, this indicates a significant number of repetitions per sample to establish reproducibility.
Data Provenance: The document does not specify the country of origin for the data. The study appears to be prospective as it involves the repeated testing of control urines under specified conditions to evaluate reproducibility.

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

The document does not mention the use of human experts to establish the ground truth for the test set in the traditional sense of consensus reading or interpretation.

4. Adjudication Method for the Test Set

No adjudication method involving multiple human readers is described. The ground truth (drug concentration) was established through an objective analytical method.

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

No MRMC comparative effectiveness study was mentioned. The device is a standalone in-vitro diagnostic test, not an AI assistance tool for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "Performance Characteristics" section describes the evaluation of the device's ability to detect drugs at specified cut-off levels and its reproducibility. This is a study of the algorithm/device only, without human-in-the-loop performance evaluation.

7. Type of Ground Truth Used

The ground truth used for the test set was GC/MS (Gas Chromatography/Mass Spectrometry) verification of drug concentrations. This is a highly accurate and commonly accepted confirmatory analytical method for drug testing, providing an objective, chemical confirmation of the presence and concentration of the target analytes.

8. Sample Size for the Training Set

The document does not explicitly state a training set or its sample size. This type of immunoassay device likely relies on established biochemical principles and manufacturing controls rather than a machine learning model that requires a discrete training dataset in the modern sense. The "training" in this context would be inherent in the device's development and optimization, rather than a separate data-driven training phase as seen in AI/ML applications.

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

Since a distinct training set (in the AI/ML sense) is not mentioned, the method for establishing its ground truth is also not provided. The development and calibration of such assays typically involve laboratory testing with known concentrations of analytes, verified by methods like GC/MS.

Summary

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American Bio Medica Corporation Rapid Drug Screen 5-Panel Test with Methamphetamine 510(k) Summary

K993796

DEC 2 1 1999

510(k) Summary

Submitter's Name/Address: American Bio Medica Corporation 300 Fairview Avenue Hudson, N. Y. 12534

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common/Usual Name or Classification Name:

Classification Number/Class:

Contact Person: Henry J. Wells Vice President of Product Development Phone: 800-227-1243 Fax: 518-822-0391

November 1999

Rapid Drug Screen 5-Panel with Methamphetamine Rapid Drug Screen 5-Panel with Methamphetamine

[no classification number]/Class II

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

The assigned 510(k) is:

Predicate Devices: 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.

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

Intended Use:

The Rapid Drug Screen 5-Panel test with Methamphetamine is used for the qualitative detection of the following abused substances in human urine: d-Amphetamine, Benzoyl ecgonine, Cannabinoids, Opiates and Methamphetamines. 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:

The Rapid Drug Screen 5-Panel test will detect drugs of abuse in human urine at the following levels:

d-Amphetamine	1000 ng/ml
Benzoyl ecgonine	300 ng/ml
Cannabinoids	50 ng/ml
Methamphetamines	1000 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 5-Panel with Methamphetamine performance.

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Conclusion:

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 21 1999

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

Re: K993796

Trade Name: Rapid Drug Screen 5-Panel Test with Methamphetamines Regulatory Class: II Product Code: LDJ, DKZ, LAF, DJG, DIO Dated: November 3, 1999 Received: November 9, 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.

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Page 2

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 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): ____________________________________________________________________________________________________________________________________________________

Device Name: Rapid Drug Screen 5-Panel Test with Methamphetamines

Indications For Use:

"Rapid Drug Screen" is not intended 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)

Joan Cooper

(Division Sign-Off) Division of Clinical Laboratory Devices 11 510(k) Number.

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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).