"Rapid Drug Screen" with methamphetamine is a one-step , 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 (750 ng/ml), Benzoyl ecgonine (225 ng/ml), Cannabinoids (50 ng/ml), Methamphetamines (1000 ng/ml) and Opiates (225 ng/ml).

"Rapid Drug Screen" is intended for use by professional laboratories. The assays are easy to perform, but should not be used without proper supervision. These immunoassay is a simplified qualatative screening method 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.

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 possitive sample will produce only one band.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and the study that proves the device meets them:

Device: Rapid Drug Screen 5-Panel with Methamphetamine

1. Table of Acceptance Criteria and Reported Device Performance

Drug Tested	Acceptance/Cut-off Level (ng/ml)	Reported Performance (Agreement with Comparator)
d-Amphetamine	750	114/115 specimens with microLINE (one discordant sample: EMIT II positive, RDS negative, 279 ng/ml amphetamine, 585 ng/ml methamphetamine)
Benzoyl ecgonine	225	115/115 specimens with microLINE
Cannabinoids	50	114/115 specimens with microLINE (one discordant sample: EMIT II negative, RDS positive, 7 ng/ml THC)
Methamphetamines	1000	256/256 negative specimens agreed with EMIT II; 193/198 positive specimens agreed with EMIT II
Opiates	300	115/115 specimens with microLINE

Note: The acceptance criteria are implicitly defined by the cut-off levels at which the device is intended to detect the drugs. The reported performance refers to the agreement with established comparator methods.

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

d-Amphetamine:
- 75 negative specimens
- 40 positive specimens
- Total: 115
Benzoyl ecgonine (cocaine):
- 75 negative specimens
- 40 positive specimens
- Total: 115
Cannabinoids (THC):
- 75 negative specimens
- 40 positive specimens
- Total: 115
Opiates:
- 75 negative specimens
- 40 positive specimens
- Total: 115
Methamphetamines:
- Total: 454 specimens
  - 256 below cut-off (negative)
  - 198 positive (by EMIT II)
Data Provenance: The data used clinical specimens. The country of origin is not specified but implicitly assumed to be the US given the submission to the FDA. The study appears to be retrospective, as it uses "clinical specimens" that were subsequently analyzed.

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

The summary does not specify the number or qualifications of experts. However, the ground truth was established by laboratory methods, not expert consensus.

4. Adjudication Method for the Test Set

Adjudication by human experts is not applicable here. The ground truth for the test set was established using reference laboratory methods:

Primary Comparator for d-Amphetamine, Benzoyl ecgonine, Cannabinoids, and Opiates: Syva EMIT II for initial positive/negative determination.
Primary Comparator for Methamphetamines: Syva EMIT II.
Confirmatory Method for all drugs: Gas Chromatography/Mass Spectrometry (GC/MS) was used to verify concentrations for both positive and negative samples, as well as discordant samples.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic test for qualitative detection of substances in urine, not an imaging device or a device requiring human interpretation for its primary output. Therefore, improvement of human readers with or without AI assistance is not relevant to this type of device.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, the studies described are standalone performance evaluations. The device's output (presence or absence of a line) is directly compared against established laboratory reference methods (EMIT II, GC/MS). There is no human interpretation integrated into the device's performance assessment itself. The intended use states it provides a "preliminary result" for use in determining the need for additional or confirmatory testing, implying it's a standalone screening tool.

7. The Type of Ground Truth Used

The ground truth used was a combination of:

Reference Immunoassay: Syva EMIT II for initial positive/negative classification.
Confirmatory Analytical Method: Gas Chromatography/Mass Spectrometry (GC/MS) was used to verify actual drug concentrations in both positive and negative samples, and importantly, to analyze discordant results. This is considered a highly reliable and definitive method for drug quantification.

8. The Sample Size for the Training Set

The summary does not provide information on a training set. For immunoassay devices like this, the development process typically involves optimizing antibody-antigen reactions and conjugation during R&D, rather than "training" an algorithm in the way a machine learning model is trained. The data presented here is for analytical performance validation/testing.

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

As no training set is described, the method for establishing its ground truth is not applicable. The development of such diagnostic devices involves extensive laboratory testing and optimization of reagents and cut-off points, but not in the sense of a data-driven "ground truth establishment" for a training set in machine learning.

Summary

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

K984525

510(k) Summary

Submitter's Name/Address:

American Bio Medica Corporation 300 Fairview Avenue Hudson, N. Y. 12534

Contact Person:

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

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common/Usual Name or Classification Name:

Classification Number/Class:

December 1998

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 PCP (510(k) No. K-964900).

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}------------------------------------------------

A negative urine will produce two colored bands, and a possitive 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 S-Panel test will detect drugs of abuse in human urine at the following levels:

d-Amphetamine	750 ng/ml
Benzoyl ecgonine	225 ng/ml
Cannabinoids	50 ng/ml
Methamphetamines	1000 ng/ml
Opiates	300 ng/ml

Accuracy for amphetamines, benzoyl ecgonine, cannabinoids, and opiate was determined by comparison to a commercially available immunoassay ( 'microLINE', DSSI, Blackwood, N. J. The clinical specimens were determined to be positive or negative by Syva EMIT II.

Amphetamines (75 negative, 40 positive): RDS and microLINE agreement: 114/115 specimens. (One discordant sample was EMIT II positive, RDS negative. It contained 279 ng/ml of amphetamine and 585 ng/ml of methamphetamine). GC/MS range of positive samples showed amphetamine ranges of 279 to 24.113 ng/ml.

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

Benzoyl ecgonine (cocaine) (75 negative, 40 positive): RDS and microLINE agreement: 115/115 specimens. GC/MS analyses of positive samples showed cocaine ranges of 249 to>1,000,000 ng/ml.

Cannabinoids (THC) (75 negative, 40 positive): RDS and microLDNE agreement: 114/115 specimens. (One discordant sample was EMIT II negative, RDS positive. It contained 7 ng/ml of THC). GC/MS analyses of the positive specimens showed THC ranges of 39 to 620 ng/ml.

Quiates (75 negative, 40 positive): RDS and microLINE agreement: 115/115 specimens. GC/MS analyses showed morphine concentrations of 353 to > 48,000 ng/ml.

Accuracy for methamphetamines was determined by comparison to Syva EMIT II using clinical specimens as follows:.

Methamphetamines (454 specimens): RDS and EMIT II agreement with specimens below the cut-off (negative): 256/256. RDS detected 193/198 specimens reported positive by EMIT II.

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 three times daily, in duplicate, for five days. The results confirmed the reproducibility of the Rapid Drug Screen 5-Panel with Methamphetamine performance.

Conclusion:

The Rapid Drug Screen 5-Panel with Methamphetamine is substantially equivalent to the Rapid Drug Screen 5-Panel with PCP test kit as demonstrated by results obtained in the studies. Four of the five analytes in the kit have been cleared by the 510(k) process (K-964900). The methamphetamine analyte has been cleared under our vendor's 510(k) (Phamatech K-972556). 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.

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 6 1999

Henry Wells Vice President, Product Development American Bio Medica Corporation 300 Fairview Avenue Hudson, NY 12534

K984525 Re: Trade Name: "Rapid Drug Screen" 5-Panel with Methamphetamine Test Regulatory Class: II Product Code: DKZ, LAF, LDJ, DJG, DIO Dated: December 18, 1998 Received: December 21, 1998

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.

Image /page/3/Picture/9 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 an eagle or bird in flight, composed of three curved lines.

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

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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely vours,

Steven Autman

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): ____________________________________________________________________________________________________________________________________________________

Device Name: Rapid Drug Screen 5-Panel with Methamphetamine

Indications For Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number X984525

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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).