'RapidOne' - Benzodiazepine Test is a one-step, lateral flow immunoassay for the detection of Benzodiazepine in urine. 'RapidOne' - Benzodiazepine Test is intended for use in the qualitative detection of : oxazepam { in human urine at 300 ng/m}.

'RapidOne' - Benzodiazepine 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' - Benzodiazepine 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' - Benzodiazepine 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 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

This document describes the acceptance criteria and the study conducted for the 'RapidOne' - Benzodiazepine Test, a qualitative immunoassay for detecting oxazepam in human urine.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the performance observed in comparison to a predicate device and established cut-offs.

Acceptance Criteria / Performance Metric	Reported Device Performance
Qualitative Detection of Oxazepam at 300 ng/ml Cut-off	Correctly identified all 40 drug-containing specimens (concentrations 310 ng/ml to 10000 ng/ml) as positive.
Agreement with Predicate Device (Instacheck) for Negative Samples	All 50 drug-free samples were correctly identified as negative by the 'RapidOne' test (and also by the predicate device).
Agreement with Predicate Device (Instacheck) for Positive Samples	All 40 drug-containing samples (confirmed positive by Syva EMIT-II and GC/MS) were correctly identified as positive by the 'RapidOne' test (and also by the predicate device).
Reproducibility - Negative Urine (0 ng/ml)	40/40 negative results (reported as >99% precision for negative samples).
Reproducibility - Below Cut-off (225 ng/ml)	32/40 negative results (reported as >80% precision for negative results at this concentration). This indicates that at concentrations below the cut-off, the device predominantly yields negative results, as expected.
Reproducibility - At Cut-off (300 ng/ml)	40/40 positive results (reported as >99% precision for positive samples at the cut-off). This demonstrates reliable detection at the specified cut-off.
Reproducibility - Above Cut-off (375 ng/ml)	40/40 positive results (reported as >99% precision for positive samples at this concentration). This demonstrates reliable detection above the specified cut-off.

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

Sample Size for Comparative Study with Predicate: 90 samples
- 50 drug-free samples
- 40 drug-containing samples
Sample Size for Reproducibility Study:
- For each concentration (0, 225, 300, 375 ng/ml): 40 tests were performed (4 times daily, twice daily, for 5 days).
Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that existing samples (some confirmed by Syva EMIT-II and GC/MS) were used.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It mentions that 40 positive specimens were "confirmed and quantified by GC/MS," and it also refers to "Syva EMIT-II" results. GC/MS is a highly accurate analytical method often used as a gold standard, and results from such tests are typically interpreted by trained laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable. The test is a qualitative immunoassay. Ground truth was established by analytical methods (GC/MS, Syva EMIT-II) rather than expert consensus on interpretation of device results requiring adjudication.

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

Not applicable. This is an in-vitro diagnostic device (immunoassay) for drug detection, not an AI-powered image analysis or diagnostic support system that involves human readers interpreting results with or without AI assistance.

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

The entire performance evaluation can be considered a standalone performance study. The device provides a direct visual result (presence or absence of a line) without immediate human interpretation-in-the-loop for the primary qualitative result. However, as an "immunoassay," a human still reads the visual output, but the "performance" described relates to the device's ability to accurately produce that visual output against known sample concentrations. The device's output itself is the "result."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth for positive samples was established using:

Syva EMIT-II: An immunoassay widely used for drug screening.
Gas Chromatography/Mass Spectrometry (GC/MS): A highly sensitive and specific analytical method considered a gold standard for confirming and quantifying drug presence in samples.
Ground truth for negative samples was "drug-free."

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or "validation set" in the context of device development. The performance data presented refers to the evaluation of the final device. For immunoassay development, optimization typically occurs during the R&D phase using various samples, but these are not usually referred to as a "training set" in the same way as machine learning.

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

Not applicable, as a distinct "training set" and its ground truth establishment are not described in the provided information for this type of medical device. The device's immunoassay principles are based on established biochemical reactions, not on learning from a large dataset.

Summary

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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:	August 4, 1999
Device Trade of Proprietary Name:	'RapidOne'-Benzodiazepine Test
Device Common/Usual Name orClassification Name:	Benzodiazepine test system
Classification Number/Class	21 C.F.R. § 862.3170 (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: _ K 992720

Predicate Device: Forefront Diagnostics, Inc. 'Instacheck' Drug Screen -Benzodiazepine Test (510(k) No.K990099.)

Test Description:

The assay employed in the 'RapidOne' - Benzodiazepine 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 negative urine will produce two colored bands, and a positive sample will produce only one band.

IntendedUse:

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

'RapidOne'-Benzodiazepine Test was compared to 'Instacheck' Drug Screen-Benzodiazepine 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.

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	32/40 neg	>80%
300	40	40/40 pos	>99%
375	40	40/40 pos	>99%

Conclusion:

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

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 graphic of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

Public Health Service

3 2000 APR

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: K992720

Trade Name: 'RapidOne' - Benzodiazepine Test Regulatory Class: II Product Code: JXM 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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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 Toutman

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 l

16992720 510(k) Number (if known):

'RapidOne' - Benzodiazepine Test Device Name:

Indications For Use:

Dean Cooph
(Division Sign-Off)
ivision of C
$10(k) Numt
Laboratory Devices
K992720

(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

§ 862.3170 Benzodiazepine test system.

(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).