'RapidOne' - Opiates Test is a one-step, lateral flow immunoassay for the detection of morphine in urine. 'RapidOne' - Opiates Test is intended for use in the qualitative detection of morphine in human urine at 300 ng/ml.

'RapidOne' - Opiates 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' - Opiates 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' - Opiates 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 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' - Opiates Test device, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Qualitative detection of morphine in human urine at 300 ng/ml.	Comparison Study: Correctly identified all 50 drug-free specimens as negative. Correctly identified all 40 drug-containing specimens (ranging from 260 ng/ml to 120,000 ng/ml) as positive.
Reproducibility for various morphine concentrations.	Reproducibility Test: - 0 ng/ml: 40/40 negative (>99% precision) - 225 ng/ml: 24/40 positive (40% precision) - 300 ng/ml: 40/40 positive (>99% precision) - 375 ng/ml: 40/40 positive (>99% precision)

Study Details

Sample sizes used for the test set and the data provenance:
- Comparison Study: 90 samples were used in total.
  - 50 were drug-free.
  - 40 contained opiates.
- Reproducibility Study: For each concentration level (0, 225, 300, 375 ng/ml), 40 tests were conducted (4 times daily for 5 days). This means 40 samples were used at each concentration for this specific test, but the provenance of these "control urines" is not specified beyond being "control urines."
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be prospective, laboratory-based evaluations using selected human urine samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the use of experts to establish ground truth for the test set. Instead, the ground truth for the 40 positive samples was established by GC/MS (gas chromatography/mass spectrometry) and quantified. The 50 drug-free samples were found to be drug-free, implying a similar analytical method or pre-selection.
Adjudication method for the test set:
- Not applicable. The study compares the device's results to a predicate device (Instacheck) and GC/MS results, not to adjudicated expert opinions.
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 MRMC comparative effectiveness study was done. This device is an immunoassay, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This was a standalone performance evaluation of the immunoassay device itself. The results are based on the device's output (presence or absence of a line). While a human interprets the line, the performance characteristics are for the device's ability to produce that visual result.
The type of ground truth used:
- Analytical Testing:
  - For positive samples, Gas Chromatography/Mass Spectrometry (GC/MS) was used for confirmation and quantification.
  - For negative samples, they were "found to be drug-free," implying analytical confirmation.
  - For the reproducibility study, "control urines" with specified concentrations were used.
The sample size for the training set:
- Not applicable. This is a chemical immunoassay, not a machine learning or AI device that requires a training set.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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JUL 15 1999

K990820

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:

May 24, 1999

Device Trade of Proprietary Name:

Device Common/Usual Name or Classification Name:

Opiate test system

'RapidOne'- Opiates Test

Classification Number/Class

21 C.F.R. § 862.3650 (Class II)

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

The assigned 510(k) is: K990820

Predicate Device: Forefront Diagnostics, Inc. 'Instacheck' Drug Screen -Morphine Test (510(k) No. K971961)

Test Description:

The assay employed in the 'RapidOne' - Opiates 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.

Intended Use:

'RapidOne' - Opiates Test is used for the qualitative detection of morphine 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'-Opiates Test will detect 300 ng/ml of morphine in urine.

'RapidOne'-Opiates Test was compared to'Instacheck' Drug Screen-Morphine 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 260 ng/ml to 120,000 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%
225	40	24/40 pos	40%
300	40	40/40 pos	>99%
375	40	40/40 pos	>99%

Conclusion:

'RapidOne'-Opiates Test is substantially equivalent to 'Instacheck' - Drug Screen -Morphine Test

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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 a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 15 1999

American Bio Medica c/o Mr. John B. Dubeck KELLER AND HECKMAN LLP 1001 G Street, N.W. Suite 500 West Washington, D.C. 20001

Re: K990820 Trade Name: 'RapidOne' - Opiates Test Regulatory Class: II Product Code: DJG, DMY, DJF 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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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 Butman

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 1 of 1

K990820 510(k) Number (if known):

'RapidOne' - Opiates Test Device Name:

Indications For Use:

Dean Cooper

Division Sign-Off Division of Clinical Laboratory Devices 990820 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 User (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).