'RapidOne'-Ecstasy' Test is used for the qualitative detection of MDMA in human urine. This immunoassay is a simplified qualitative screening method that provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

'RapidOne-Ecstasy' Test is a one-step, lateral flow immunoassay for the detection of 3,4-methylenedioxymethamphetamine (MDMA or 'Ecstasy') at 1000 ng/ml in urine.

'RapidOne-Ecstasy'-Test is intended for the qualitative detection of MDMA in human urine.

'RapidOne-Ecstasy' Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to perform and provides a result within 5-10 minutes. 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., GC/MS.

'RapidOue-Ecstasy' Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred chemical method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are use.

Device Description

The assay employed in the 'RapidOne'-Ecstasy' Test is based on the same principle of highly specific reaction between antigens and antibodies.

This assay is a one-step, immunoassay in which a specially labeled drug (drug conjugate) competes with drug that 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 a membrane. In the absence of any drug in the urine sample, the colloidal goldantibody 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 or absence of drug in the urine, and therefore, should be present in all reactions.

AI/ML Overview

The 'RapidOne'-Ecstasy' Test is designed for the qualitative detection of MDMA (Ecstasy) at a cut-off concentration of 1000 ng/ml in human urine. The study compared its performance against a predicate device, the MedTox Verdict II-Methamphetamine Test, and used GC/MS as a confirmatory method for positive results.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Qualitative detection of MDMA at 1000 ng/ml cut-off.	Comparison Study:- All 50 drug-free samples were correctly identified as negative by both 'RapidOne'-Ecstasy' Test and the predicate device.- All specimens with MDMA concentrations of 1009 ng/ml or greater were found to be positive by both systems.
Reproducibility at concentrations around the cut-off.	Reproducibility Study (80 replicates per concentration):- No drug: 80 Negatives (100% correct)- 500 ng/ml: 8 Positives, 72 Negatives (8.75% positive, 91.25% negative)- 750 ng/ml: 40 Positives, 40 Negatives (50% positive, 50% negative)- 1000 ng/ml (cut-off): 78 Positives, 2 Negatives (97.5% positive, 2.5% negative)- 1250 ng/ml: 80 Positives, 0 Negatives (100% positive)

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

Sample Size: 100 samples were used for the comparison study with the predicate device. For the reproducibility study, 80 replicates were run at each of 5 different concentrations, totaling 400 tests.
Data Provenance: Not explicitly stated, but implies clinical samples used for the comparison. The reproducibility study likely used spiked control urine samples. No country of origin is mentioned, and it is a retrospective analysis of collected samples.

3. 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 by laboratory methods (Syva Emit II for initial screening and GC/MS for confirmation), not by expert interpretation.
Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

Adjudication Method: Not applicable in the traditional sense of human readers adjudicating results. The ground truth for positive samples was confirmed by GC/MS, which is an objective chemical analysis method. For negative samples, the "drug-free" status was initially determined by Syva Emit II.

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 information is not applicable. The 'RapidOne'-Ecstasy' Test is a lateral flow immunoassay, a diagnostic device that directly provides a result, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

This is partially applicable in the sense that the device itself is a standalone test that produces a result without human interpretation of complex data. However, a human is required to perform the test and observe the line formation. The performance data presented (comparison with predicate and reproducibility) reflects the device's standalone analytical performance.

7. The type of ground truth used:

Expert Consensus: No
Pathology: No
Outcomes Data: No
Other:
- For identifying "drug-free" samples, Syva Emit II was used.
- For confirming positive results for the amphetamine group and specifically MDMA, GC/MS (Gas Chromatography/Mass Spectrometry) analysis was performed. GC/MS is a highly sensitive and specific analytical technique considered the gold standard for drug confirmation.

8. The sample size for the training set:

Not applicable. This device is a diagnostic immunoassay that works based on biochemical reactions (antigen-antibody binding), not a machine learning model that requires a training set.

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

Not applicable. As stated above, this is not a machine learning device.

Summary

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NOV 2 6 2001

K013180

510(k) Summary

Submitter's Name/Address:

American Bio Medica Corporation 122 Smith Road Kinderhook, NY 12106

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common/Usual Name or Classification Name:

Contact Person:

Henry Wells VP Product Development Phone: 518 758 8158 518-758 8171 Fax:

September 21, 2001

'RapidOne'-Ecstasy' Test

MDMA test system

Classification Number/Class

[no classification regulation]/ClassII

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

The assigned 510(k) number is: _ HO13180

Predicate Device: MedTox Diagnostics, Inc., Verdict II-Methamphetamine Test. (510(k) No. K-010226).

Test Description:

The assay employed in the 'RapidOne'-Ecstasy' Test is based on the same principle of highly specific reaction between antigens and antibodies.

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conjugate. An absence of a color band (line) in the 'test' area is indicative of a positive result.

Intended use:

"RapidOne'-Ecstasy' Test is used for the qualitative detection of MDMA in human urine. This immunoassay is a simplified qualitative screening method that provides only a I his ininutiousses is a varip internaining the need for additional or confirmatory testing, i.e., GC/MS.

Performance Characteristics:

'RapidOne'-Ecstasy' Test will detect 1000 ng/ml of MDMA in urine.

'RapidOne'-Ecstasy' Test was compared to MedTox Verdict II-Methamphetamine Test. One hundred (100) samples were selected for evaluation. Of the 100 specimens, fifty (50) were found to be drug-free by Syva Emit II. Both immunaoassays correctly identified all the specimens that contained no drug as negative. GC/MS analyses were performed on samples that were screened as positive for the amphetamine group. Specimens containing only MDMA (395 to 19496 ng/ml) were selected for this study. All specimens that contained MDMA concentrations of 1009 ng/ml or greater were found to be positive by both systems. Verdict II did determine three specimens which contained 816, 895 and 958 ng/ml as positive.

Reproducibility was evaluated using control urines containing concentrations above and below the stated cut-off. Eighty (80) replicates were run at each concentration,

Concentration(ng/ml)	#	RDS Result
		Pos	Neg
No drug	80	0	80
500	80	8	72
750	80	40	40
1000	80	78	2
1250	80	80	0

Conclusion:

'RapidOne'-Ecstasy' Test is substantially equivalent to MedTox Verdict II-Methamphetamine Test for the qualitative detection of MDMA in human urine.

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Comparison Between 'RapidOne'-Ecstasy Test and MedTox Verdict II-Methamphetamine Test

'RapidOne'

'Verdict II'

Intended Use:	For professional use	For professional use
Type of Assay	Lateral flow immunoassay	Lateral flow immunoassay
Analyte:	MDMA	MDMA
Cut-off	1000 ng/ml	1000 ng/ml
SampleApplication:	Dipping in specimen	Specimen added dropwise

Assay time:

5-10 minutes

3-8 minutes

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 2 6 2001

Mr. Henry Wells V.P. Product Development American Bio Medica Corporation 9110 Red Branch Road Columbia, MD 21045

K013180 Re: Trade/Device Name: 'RapidOne-Ecstasy' Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC Dated: September 21, 2001 Received: September 24, 2001

Dear Mr. 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 I his lection. The FDA finding of substantial equivalence of your device to a legally marketed predication. The 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 11 you dostre by 11 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, (301) 59 mto 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/cdrb/dsma/dsmamain.html".

Sincerely yours,

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

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510(k) Number (if known): _K013180

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

'RapidOne-Ecstasy' Test is a one-step, lateral flow immunoassay for the deection of 3,4-RapidOne-Ecstasy Test Is a one stop, lava a 'Ecstasy') at 1000 ng/ml in urine.

'RapidOne-Ecstasy'-Test is intended for the qualitative detection of MDMA in human urine.

'RapidOne-Ecstasy' Test is intended for professional use. It is not intended for over-the-counter sales to nonprofessionals. The assay is easy to processional use. It is not included withouts result for use immunoassay is a simplified, qualitative screening method that orosides only a preliminary result for use in immunoassay is a smiplified, qualiante screening memoc aller profices and profited and proposition of the matery (GC/MS).

'RapidOue-Ecstasy' Test provides only a preliminary analytical result. A more specific alternate "RapidOne-Ecstasy" Test provides only a premimal y unarythed result. GC/MS is the preferred chemical method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are use.

Sharon pt Rose

(Division Sign-Off) Division of Clinical Laboratory Devices KO13180 510(k) Number_

(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

§ 862.3610 Methamphetamine test system.

(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).