'RapidOne' - Marijuana Test is a one-step, lateral flow immunoassay for the detection of marijuana in urine. 'RapidOne' - Marijuana Test is intended for use in the qualitative detection of marijuana metabolite, 11-nor-9-carboxy-delta-9-THC in human urine at 50 ng/ml.

'RapidOne' - Marijuana 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) or HPLC.

'RapidOne' - Marijuana 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 assay employed in the 'RapidOne'- Marijuana Test is 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 'RapidOne' - Marijuana Test, based on your provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Qualitative detection of 11-nor-9-carboxydelta-9-THC in human urine at 50 ng/ml.	Comparison to Predicate Device: Both immunoassays (RapidOne and Instacheck) correctly identified all 50 drug-free specimens as negative and all 40 drug-containing specimens (concentrations 39 ng/ml to 2200 ng/ml) as positive. Reproducibility (Cut-off 50 ng/ml):- 0 ng/ml: 40/40 negative (>99% precision)- 37.5 ng/ml: 32/40 positive (20% precision) (Note: This is below cut-off, so some negative results are expected due to competitive binding near the threshold)- 50.0 ng/ml: 40/40 positive (>99% precision)- 75.0 ng/ml: 40/40 positive (>99% precision)

Acceptance Criteria

Reported Device Performance

Qualitative detection of 11-nor-9-carboxydelta-9-THC in human urine at 50 ng/ml.

Comparison to Predicate Device: Both immunoassays (RapidOne and Instacheck) correctly identified all 50 drug-free specimens as negative and all 40 drug-containing specimens (concentrations 39 ng/ml to 2200 ng/ml) as positive. Reproducibility (Cut-off 50 ng/ml):- 0 ng/ml: 40/40 negative (>99% precision)- 37.5 ng/ml: 32/40 positive (20% precision) (Note: This is below cut-off, so some negative results are expected due to competitive binding near the threshold)- 50.0 ng/ml: 40/40 positive (>99% precision)- 75.0 ng/ml: 40/40 positive (>99% precision)

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 90 samples (50 drug-free, 40 drug-containing).
- Data Provenance: Not explicitly stated, but given the context of a 510(k) submission for a US market, it's highly likely to be U.S.-based. The study appears to be retrospective, as samples were "selected for evaluation" and 40 positive specimens were "confirmed and quantified by GC/MS," implying prior testing.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not specified.
- Qualifications: "Syva EMIT-II" was used for initial classification, and "GC/MS" was used for confirmation and quantification of positive samples. These are laboratory-based, instrumental methods. No human expert interpretation of the initial Syva EMIT-II or GC/MS results is mentioned for establishing ground truth; rather, the results of these analytical methods themselves serve as the ground truth.
Adjudication Method for the Test Set:
- No explicit adjudication method (like 2+1, 3+1) is mentioned. The ground truth for positive samples was established by "Syva EMIT-II" and "confirmed and quantified by GC/MS." For negative samples, it was just "found to be drug-free" (presumably by Syva EMIT-II).
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:
- No, an MRMC study was not done. This device is a rapid immunoassay kit, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance evaluation was done. The device's performance was compared to the predicate device and benchmarked against GC/MS for positive samples. The "RapidOne" test itself is a standalone qualitative screening method.
The Type of Ground Truth Used:
- Analytical/Laboratory Ground Truth:
  - For positive samples: Confirmed and quantified by Gas Chromatography/Mass Spectrometry (GC/MS).
  - For negative samples: Identified as "drug-free" (presumably by a validated method like Syva EMIT-II).
The Sample Size for the Training Set:
- The document does not specify a separate training set. The descriptions relate to performance evaluation and reproducibility, implying these samples are part of a verification/validation set rather than a training set for a machine learning model. This is an immunoassay device, which typically does not involve machine learning training in the same way an AI algorithm would.
How the Ground Truth for the Training Set was Established:
- As no separate training set is explicitly mentioned for a machine learning model, this question is not applicable to the provided document. The device's design is based on established immunoassay principles.

Summary

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JUL - 7 1999

K990818

510(k) Summary

Submitter's Name/Address:

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

Contact Person:

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:

June 3, 1999

'RapidOne'- Marijuana Test

Cannabinoid test system

Classification Number/Class

21 C.F.R. § 862.3870 (Class II)

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

The assigned 510(k) is: K990818

Predicate Device: Forefront Diagnostics, Inc. 'Instacheck' Drug Screen -Marijuana Test (510(k) No. K971959)

Test Description:

The assay employed in the 'RapidOne'- Marijuana Test is 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.

IntendedUse:

'RapidOne' - Marijuana Test is used for the qualitative detection of 11-nor-9-carboxydelta-9-THC in human urine. 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:

'RapidOne'-Marijuana Test will detect 50 ng/ml of 11-nor-9-carboxy-delta-9-THC in urine.

'RapidOne'-Marijuana Test was compared to'Instacheck' Drug Screen-Marijuana Test. Ninety (90) samples were selected for evaluation, fifty (50) of which were found to be drug-free and thirty (40) tested as positive by Syva EMIT-II. The forty positive specimens were confirmed and quantified by GC/MS. Both immunoassays correctly identified all of the specimens which contained no drug as negative and determined the 40 drug-containing specimens, ranging in concentration of 39 ng/ml to 2200 ng/ml, to be positive.

Reproducibility was evaluated using control urines containing concentrations above and below the stated cut-off. Negative urines were also used. Each sample, at each concentration of analyte, was tested 4 times, twice daily, for 5 days.

Conc. (ng/ml)	#	Result	Precision
0	40	40/40 neg	>99%
37.5	40	32/40 pos	20%
50.0	40	40/40 pos	>99%
75.0	40	40/40 pos	>99%

Conclusion:

'RapidOne'-Marijuana Test is substantially equivalent to 'Instacheck' - Drug Screen -MarijuanaTest

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three intertwined snakes and a staff.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL - 7 - 7 - 00

American Bio Medica Corporation c/o Mr. John B. Dubeck Keller And Heckman LLP 1001 G Street, N.W. Suite 500 West Washington, D.C. 20001

Re: K990818 Trade Name: 'RapidOne' - Marijuana Test Regulatory Class: II Product Code: LDJ Dated: June 16, 1999 Received: June 16, 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 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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l 1 Page of

K990818 510(k) Number (if known):

'RapidOne' - Marijuana Test Device Name:

Indications For Use:

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number K990818

(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)

1 1

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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).