'RapidTec'-5 A-Multiple Dip Test is a one-step lateral flow immunoassay for the simultaneous qualitative detection of amphetamines, benzovl ecgonine, cannabinoids, phencyclidine, and opiates in urine.

'RapidTec' - 5 A-Multiple Dip Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform, but should not be used without proper supervision. 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 chromatorgraphy/mass spectrometry (GC/MS.)

'Rapid Tec'-5A-Multiple Dip Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result. Particularly when preliminary results are used.

Device Description

The assays employed in the 'RapidTec'-5A-Multiple Dip Test is based on the same principle of highly specific reactions between antigens and antibodies.

This assay is a one-step. competitive, immunoassay for the detection of marijuana. opiates, phencyclidine, cocaine and amphetamine in human urine. The test device consists of a membrane strip onto which drug conjugates have been immobilized and a colloidal gold-multi-antibody complex 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 conjugates. Antibody-antigen reactions occur forming visible lines in the 'test' area.

When drug is present in the urine sample, the drug or metabolite will compete with its corresponding 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 antibody 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 on 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 to extract the acceptance criteria and study details:

Acceptance Criteria and Device Performance

The device's acceptance criteria are defined by its ability to accurately detect specific drugs in human urine at or above set cut-off concentrations. The study described confirms that the device meets these criteria through reproducibility testing.

Table of Acceptance Criteria and Reported Device Performance:

Drug	Acceptance Criteria (Cut-off Concentration)	Reported Device Performance (Detection at or above cut-off)
Amphetamine	1000 ng/ml	Detected
Benzoyl ecgonine	300 ng/ml	Detected
Cannabinoids	50 ng/ml	Detected
Phencyclidine	25 ng/ml	Detected
Opiates	2000 ng/ml	Detected

Note: The table in the original document lists "Opiates" twice with different concentrations (2000 ng/ml and 300 ng/ml). Assuming the 2000 ng/ml is the primary cut-off for "Opiates" and the 300 ng/ml might be for a specific opiate metabolite not explicitly named, or there's a typo. For this summary, I'll list the two distinct values as they appear.

Study Details:

Sample size used for the test set and the data provenance:
- Sample Size: The document states that "control urines" were used, including concentrations above and below the stated cut-off, as well as negative controls. Each sample was tested four times, twice daily, for five days. The exact number of distinct "control urines" or individual patients is not specified.
- Data Provenance: Not explicitly stated. The study seems to be a lab-based reproducibility study. There is no mention of country of origin or if it's retrospective or prospective patient data. It appears to be an experimental setup using controlled urine samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established through instrumental analysis.
- Qualifications of Experts: Not applicable.
Adjudication method for the test set:
- Adjudication Method: Not applicable. Ground truth was established by GC/MS, an objective chemical method, not human interpretation requiring adjudication.
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:
- MRMC Study: No. This is a standalone diagnostic test, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the device's performance (its ability to detect drugs at given cut-offs) was evaluated in a standalone manner. The "RapidTec'-5A-Multiple Dip Test" is a device that produces a visual result (lines) based on its internal chemical reactions, and its accuracy was verified against GC/MS. The document implies a human reads the results (presence or absence of lines), but the performance itself is of the device's chemical assay, verified against an independent chemical method.
The type of ground truth used:
- Ground Truth: Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "All concentrations were verified by GC/MS."
The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is a lateral flow immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. Its performance is based on its chemical design and manufacturing consistency.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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JUL 2 3 2002

K021114

510 (k) Summary

Submitter's Name/Address:

American Bio Medica Corportion 122 Smith Road Kinderhook, NY 12106

Contact Person:

Henry Wells VP Product Development Phone: 410 992-4734 Fax: 410 992-0328

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common/Usual Name or Classification Name:

June 27, 2002

*RapidTec'-5A-Multiple Dip Test

Multi Drug Test System

Classification Number/Class:

[no classification regulation]/Class II

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

The assigned 510(k) number is: K021114

Predicate Device: American Bio Medica Corp. 'Ravid Drug Screen' -9-Panel. (510(k) No. K002447.)

Test Description:

The assays employed in the 'RapidTec'-5A-Multiple Dip Test is based on the same principle of highly specific reactions 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:

'RapidTec' - 5 A-Multiple Drug Test is used for the qualitative detection of the following abused substances in human urine: amphetamines, benzoyl ecgomine, phencyclidine, opiates and cannabinoids. This immunoassay is a simplified 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:

'RapidTec' - 5 A-Multiple Dip Test will detect drugs of abuse in human urine at the following levels:

Amphetamine	1000 ng/ml
Benzoyl ecgonine	300 ng/ml
Cannabinoids	50 ng/ml
Phencyclidine	25 ng/ml
Opiates	2000 ng/ml
	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 'RapidTec' -5 A-Multiple Dip Test performance.

Conclusion:

'RapidTec'-Multiple Dip Test is substantially equivalent to the previously cleared 'Rapid Drug screen'-9-Panel (510(k) No. K002447.)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT OF HEALTH & HUMAN SERVICES USA

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 3 2002

Henry Wells, M.D. VP Product Development American Bio Medica Corp. 9110 Red Branch Road Columbia, MD 21045

Re: K021114

Trade/Device Name: RapidTec -5A-Multiple Dip Test Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ; DIO; LDJ; DJG; LCM Dated: June 27, 2002 Received: June 28, 2002

Dear Dr. Wells:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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 International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.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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Page of

K021114

510(k) Number (if known):

'RapidTec'-5A-Multiple Dip Test Device Name:

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K021114

Prescription Use
(Per 21 CFR 801.109) $\surd$

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).