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

'RapidOne' - Barbiturate 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).

'RapidOne' - Barbiturate 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'- Barbiturate 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 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 anti-amphetamine monoclonal antibody has been immobilized. A colloidal gold-BSAamphetamine complex is dried on a reagent pad. In the absence of any drug in the urine sample, the colloidal gold-complex moves with the urine by capillary action to contact the immobilized drug antibody. 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.

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 the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The device's intended performance is to accurately detect secobarbital in urine at a specific cut-off concentration. The key acceptance criterion is the ability to correctly identify positive and negative samples around this cut-off.

Acceptance Criteria	Reported Device Performance
Detect 300 ng/ml of secobarbital in urine.	Comparison Study: 'RapidOne'-Barbiturate Test correctly identified all 40 drug-containing specimens (ranging from 310 ng/ml to 10000 ng/ml) as positive. It also correctly identified all 50 drug-free specimens as negative. Reproducibility Study: - At 0 ng/ml: 40/40 negative (>99% precision) - At 150 ng/ml: 40/40 negative (>99% precision) - At 225 ng/ml: 32/40 positive (>20% precision) - Note: This concentration is below the stated 300 ng/ml cut-off, so some negative results are expected and acceptable if the device is designed to be highly sensitive at 300ng/ml. However, the precision value is low and indicates variability close to the cut-off. - At 300 ng/ml: 40/40 positive (>99% precision) - At 375 ng/ml: 40/40 positive (>99% precision)
Qualitative detection of secobarbital.	The device is described as a "simplified qualitative screening method." The performance data demonstrates its ability to categorize samples as positive or negative based on the presence of secobarbital above the cut-off.
Substantial equivalence to predicate device.	The conclusion states that 'RapidOne'-Barbiturate Test is substantially equivalent to 'Instacheck' - Drug Screen - Barbiturate Test. The comparison study results support this by showing similar performance.

2. Sample Size Used for the Test Set and Data Provenance

Comparison Study:
- Sample Size: 90 samples (50 drug-free, 40 drug-containing).
- Data Provenance: Not explicitly stated, but given context of FDA submission, likely from a US-based laboratory or clinical setting. The study used samples that had been tested by "Syva EMIT-II" and confirmed by "GC/MS," suggesting human biological samples. It's a retrospective analysis of previously collected and analyzed samples for the comparison study.
Reproducibility Study:
- Sample Size: For each concentration level (0, 150, 225, 300, 375 ng/ml), 40 tests were performed (4 times daily for 5 days). This implies that a set of control urines (presumably pooled or spiked samples) were tested multiple times, not 40 individual patient samples per concentration.
- Data Provenance: "Control urines containing concentrations above and below the stated cut-off. Negative urines were also used." These are likely lab-prepared or spiked samples, not individual patient samples. This is a prospective experimental study conducted in a controlled lab setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Comparison Study Ground Truth: The ground truth for the 40 positive samples was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a gold standard analytical method for drug quantification. The number of "experts" is not applicable in the human-reader sense, as GC/MS is an objective analytical measurement. However, qualified laboratory personnel would have conducted and interpreted the GC/MS results.
Reproducibility Study Ground Truth: The ground truth was established by the known, spiked concentrations of secobarbital in the control urines.

4. Adjudication Method for the Test Set

Comparison Study: Not explicitly an adjudication process involving human reviewers for the device's results. The 'RapidOne' results were directly compared to the GC/MS confirmed results.
Reproducibility Study: No adjudication method mentioned, as the results were direct measurements against known concentrations.

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

No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) immunoassay, not an AI-powered image analysis or diagnostic tool that assists human readers. Its output is a direct qualitative result (positive/negative line on a strip), not input for human interpretation that would be enhanced by AI.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Yes, a standalone study was done. The entire performance characterization (comparison and reproducibility studies) is based on the 'RapidOne' device's performance by itself, without human-in-the-loop assistance for interpretation beyond reading the visible lines. The device provides a direct qualitative result.

7. The Type of Ground Truth Used

Comparison Study: Analytical Gold Standard (GC/MS) for the positive samples and presumed verified drug-free status for the negative samples.
Reproducibility Study: Known, spiked concentrations in control urines.

8. The Sample Size for the Training Set

Not Applicable / Not Provided. This device is an immunoassay, not a machine learning or AI-based device that typically requires a distinct "training set" in the computational sense. Its design and cutoff are based on established biochemical principles and analytical performance targets.

9. How the Ground Truth for the Training Set Was Established

Not Applicable / Not Provided. As noted above, there isn't a "training set" in the typical AI/ML context. The device's operating characteristics (e.g., antibody specificity, concentration of reagents) are determined during its development based on chemical and biological principles and then validated through performance studies like those described.

Summary

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APH 3 100

510(k) Summary

Submitter's Name/Address:	Contact Person:
American Bio Medica Corporation300 Fairview AvenueHudson, N.Y. 12534	Henry WellsVice President of ProductDevelopmentPhone: 518-822-8882Fax: 518-822-0391
Date of Preparation of this Summary:	June 30, 1999

Device Trade of Proprietary Name:

Device Common/Usual Name or Classification Name:

'RapidOne'-Barbiturate Test

Barbiturate test system

Classification Number/Class

21 C.F.R. § 862.3150 (Class II)

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

The assigned 510(k) number is: K992451

Predicate Device: Forefront Diagnostics, Inc. 'Instacheck' Drug Screen -Barbiturate Test (510(k) No.K990107.)

Test Description:

The assay employed in the 'RapidOne'- Barbiturate 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.

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.

IntendedUse:

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

'RapidOne'-Barbiturate Test was compared to 'Instacheck' Drug Screen-Barbiturate Test. Ninety (90) samples were selected for evaluation, fifty (50) of which were found to be drug-free and forty (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 310 ng/ml to 10000 ng/ml, to be positive.

Revoducibility 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%
150	40	40/40 neg	>99%
225	40	32/40 pos	>20%
300	40	40/40 pos	>99%
375	40	40/40 pos	>99%

Conclusion:

'RapidOne'-Barbiturate Test is substantially equivalent to Instacheck' - Drug Screen -Barbiturate Test

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

APR 3 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Henry Wells, Ph.D. Vice President of Product Development American Bio Medica Corporation 122 Smith Road Kinderhook, New York 12106

Re: K992451

Trade Name: 'RapidOne' - Barbiturate Test Regulatory Class: II Product Code: DIS Dated: February 14, 2000 Received: February 15, 2000

Dear Dr. Wells:

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

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" (21CFR 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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רי

510(k) Number (if known): K993451

'RapidOne' - Barbiturate Test Device Name:

Indications For Use:

Dean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992451

(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

§ 862.3150 Barbiturate test system.

(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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).