'Rapid Drug Screen' 5-Panel test is a one-step, lateral flow immunoassay for the simultaneous detection of 5 abused substances in urine (each assay occupies a separate channel). 'Rapid Drug Screen' 5-Panel test is intended for use in the qualitative detection of the following 5 drugs of abuse in human urine at the following levels:

d-Amphetamine 1000 ng/ml
Benzoyl ecgonine 300 ng/ml
Cannabinoids 50 ng/ml
Opiates 300 ng/ml
Phencyclidine (PCP) 25 ng/ml

'Rapid Drug Screen' 5-Panel test is intended for professional use. It is not intended for over the counter sale to non-professionals. 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-chromatography/mass spectrometry (GC/MS).

'Rapid Drug Screen' 5-Panel test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order 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.

Device Description

The assays employed in the 'Rapid Drug Screen' - 5-Panel 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 goldantibody 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 negative.

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-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 of 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 a breakdown of the acceptance criteria and study information for the K993151 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are its ability to detect specific drugs at predefined concentration levels, which are also the reported performance characteristics.

Drug Name	Acceptance Criteria (Detection Level)	Reported Device Performance (Detection Level)
d-Amphetamine	1000 ng/ml	1000 ng/ml
Benzoyl ecgonine (Cocaine Metabolite)	300 ng/ml	300 ng/ml
Cannabinoids (11-nor-9-carboxy-delta-9-THC)	50 ng/ml	50 ng/ml
Opiates	300 ng/ml	300 ng/ml
Phencyclidine (PCP)	25 ng/ml	25 ng/ml

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "The sensitivity, reproducibility and accuracy for each of the assays have cleared the 510(k) process." without providing details of the studies to demonstrate this.

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

The document does not provide any information about the number or qualifications of experts used to establish the ground truth for the test set.

4. Adjudication method for the test set

The document does not specify any adjudication method used for the test set.

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.

This device is a qualitative immunoassay for drug detection, not an AI-powered diagnostic tool requiring human reader interpretation. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance was not relevant or performed for this device.

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

This device is an immunoassay, which is a standalone chemical test. Its performance is evaluated purely based on its ability to detect the target substances at specified concentrations in a sample. Therefore, yes, a standalone performance evaluation was done as the device operates without human-in-the-loop performance for result generation, though human interpretation of the visual lines is required.

7. The type of ground truth used

The ground truth for this type of immunoassay would typically be established by:

Known concentrations of drugs in spiked urine samples: This allows for precise control of the target analyte's presence and concentration. This is implied by the "detection levels" mentioned.
Confirmatory analytical methods: The document explicitly states that the immunoassay "provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e., gas chromatography/mass spectrometry (GC/MS)." This indicates that GC/MS is considered the gold standard for confirmation and would likely be used to establish ground truth for testing.

8. The sample size for the training set

The document does not specify the sample size for any training set. Given that this is an immunoassay and not an algorithmic device in the modern AI sense, the concept of a "training set" as it relates to machine learning is not applicable here. The development of such assays typically involves optimizing reagents and conditions rather than training an algorithm.

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

As noted above, a "training set" in the context of an AI algorithm is not applicable here. The development of the immunoassay's ability to detect drugs at specific levels would have involved laboratory experiments using:

Known concentrations of target drugs: The ground truth for optimizing the assay would be the actual, known concentration of the drugs in the samples used during development.
Reference methods (e.g., GC/MS): During development, comparison against established, highly accurate methods like GC/MS would be used to ensure the immunoassay's accuracy at its specified cut-off levels.

Summary

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K993151

JAN 1 0 2000

510(k) Summary

Submitter's Name/Address:

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

Contact Person:

November 2, 1999

Multidrug test system

Henry Wells Vice President of Product Development Phone: 518-822-8882 Fax: 518-822-0391

Date of Preparation of this Summary:

Device Trade of Proprietary Name:

Device Common/Usual Name or Classification Name:

Classification Number/Class

[no classification regulation]/Class II

'Rapid Drug Screen'-5-Panel

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

The assigned 510(k) number is: __K993151

Predicate Device:		American Bio Medica 'RapidOne' Single Tests:
	Opiates	510(k) No.K990820
	Marijuana	510(k) No.K990822
	Cocaine	510(k) No.K990822
	Amphetamine	510(k) No.K992452
		And Forefront Diagnostics 'InstaCheck'
	PCP	510(k) No.K980084

Test Description:

The assays employed in the 'Rapid Drug Screen' - 5-Panel 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:

'Rapid Drug Screen'-5-Panel is used for the qualitative detection of d-amphetamine, benzoyl ecgonine, cannabinoids, opiates, and phencyclidine in human urine. This immunoassay system 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).

'Rapid Drug Screen'-5-Panel is not for point of care uses.

Performance Characteristics:

'Rapid Drug Screen' - 5-Panel will detect the 5 drugs in urine at the following levels:

d-Amphetamine	1000 ng/ml
Benzoyl ecgonine (Cocaine Metabolite)	300 ng/ml
Cannabinoids
(11-nor-9-carboxy-delta-9-THC)	50 ng/ml
Opiates	300 ng/ml
Phencyclidine (PCP)	25 ng/ml

Conclusion

The same assay strips which are used in the single drug assays have been incorporated into the 'Rapid Drug Screen'-5-Panel format. The sensitivity, reproducibility and accuracy for each of the assays have cleared the 510(k) process. The independence of each channel has been demonstrated in this submission. 'Rapid Drug Screen'-5-Panel is substantially equivalent to a combination of the following:

'RapidOne' Opiates Test	K990820
'RapidOne' Cocaine Test	K990822
'RapidOne' Marijuana Test	K990818
'RapidOne' Amphetamine Test	K992452
'InstaCheck' PCP Test	K980084

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle head with three curved lines representing the feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle head.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

'JAN 1 0 2000

American Bio Medica c/o Mr. John B. Dubeck, Esq. Keller and Heckman LLP 1001 G Street NW, Suite 500W Washington, DC 20001

Re: K993151

Trade Name: Rapid Drug Screen 5 Panel Test Regulatory Class: II Product Code: DJG, DMY, DJF, DIO, LDJ, DKZ, DOD, LCL Dated: November 23, 1999 Received: November 23, 1999

Dear Mr. Dubeck:

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 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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510(k) Number (if known): 长 9 9 3 LSI

'Rapid Drug Screen' 5 - Panel Test Device Name:

Indications For Use:

d-Amphetamine	1000 ng/ml
Benzoyl ecgonine	300 ng/ml
Cannabinoids	50 ng/ml
Opiates	300 ng/ml
Phencyclidine (PCP)	25 ng/ml

Sean Cooper
Division Sign-Off
Laboratory Devices

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

(PLEASE DO NOT WRITE BELOW THIS LIÑÈ-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

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).