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

'RapidOne' - Cocaine 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' - Cocaine 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'- Cocaine 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 summary of the acceptance criteria and the study details for the 'RapidOne'- Cocaine Test, based on the provided 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list formal acceptance criteria with specific performance metrics such as sensitivity, specificity, or accuracy targets. Instead, the performance is demonstrated through comparison to a predicate device and evaluation against a stated cut-off concentration.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Detection of Benzoyl Ecgonine	Detect 300 ng/ml of benzoyl ecgonine in urine	The device detected 300 ng/ml of benzoyl ecgonine in urine.
Agreement with Predicate Device	High agreement with 'Instacheck' Drug Screen - Cocaine Test	- Correctly identified all 50 drug-free samples as negative. - Correctly identified all 40 drug-containing samples as positive.
Reproducibility - Negative Urine	>99% agreement for negative samples	40/40 negative results (>99% precision) when drug concentration was 0 ng/ml.
Reproducibility - Near Cut-off (225 ng/ml)	Not explicitly stated, but high positive rate expected beyond noise for negative.	20/40 positive results (50% precision) at 225 ng/ml.
Reproducibility - At Cut-off (300 ng/ml)	>99% positive results	40/40 positive results (>99% precision) at 300 ng/ml.
Reproducibility - Above Cut-off (375 ng/ml)	>99% positive results	40/40 positive results (>99% precision) at 375 ng/ml.

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

Sample Size: 90 samples were used for the comparative evaluation.
- 50 drug-free samples.
- 40 drug-containing samples.
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using selected samples. It does not mention prospective collection or specific geographic locations.

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

The document does not mention the use of experts to establish the ground truth for individual samples.
The ground truth for the 40 positive samples was established by GC/MS confirmation and quantification. This is considered the "gold standard" for drug testing.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1) is mentioned. The comparison was directly between the test device, the predicate device, and GC/MS results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in-vitro diagnostic test, not an imaging or diagnostic aid that would typically involve multiple human readers.

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

Yes, this study represents a standalone performance evaluation. The 'RapidOne' - Cocaine Test is a qualitative immunoassay strip, meaning its "algorithm" (the chemical reaction and visual line determination) operates independently. The results are read visually, but the study focuses on the device's inherent ability to detect the analyte based on its chemical principles.

7. The Type of Ground Truth Used

The ground truth used for the positive samples was confirmatory testing by Gas Chromatography/Mass Spectrometry (GC/MS). For negative samples, the ground truth was "drug-free" status, presumed to be established by prior testing or known origin.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. This type of immunoassay device typically relies on established chemical and biological principles and manufacturing controls rather than machine learning models that require distinct training sets. The 90 samples described are for performance evaluation/validation.

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

As no separate training set is explicitly mentioned for a machine learning context, this question is not directly applicable. If considering the "development" of the device, the ground truth for optimizing the immunoassay would have been based on known concentrations of benzoyl ecgonine, likely confirmed by analytical methods, but details regarding this development process are not provided in the 510(k) summary.

Summary

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JUL 15 1999

K990822

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

'RapidOne' - Cocaine Test

Date of Preparation of this Summary:

Device Trade of Proprietary Name:

Device Common/Usual Name or Classification Name:

June 3, 1999

Cocaine and cocaine metabolite test system

Classification Number/Class

21 C.F.R. § 862.3250 (Class II)

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

The assigned 510(k) is: K990822

Predicate Device: Forefront Diagnostics, Inc. 'Instacheck' Drug Screen -Cocaine Test (510(k) No. K971957)

Test Description:

The assay employed in the 'RapidOne'- Cocaine 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'- Cocaine Test is used for the qualitative detection of benzoyl ecgonine 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'-Cocaine Test will detect 300 ng/ml of benzoyl ecgonine in urine.

'RapidOne'-Cocaine Test was compared to 'Instacheck' Drug Screen-Cocaine 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 249 ng/ml to 55,000 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	20/40 pos	50%
300	40	40/40 pos	>99%
375	40	40/40 pos	>99%

Conclusion:

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

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Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized image of a bird or other winged creature, with three lines representing the wings.

JUL 15 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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: K990822 Trade Name: 'Rapid One' -- Cocaine test Regulatory Class: II Product Code: DIO 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 OS 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

K990822 510(k) Number (if known):

'RapidOne' - Cocaine Test Device Name:

Indications For Use:

Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K990822

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use t (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3250 Cocaine and cocaine metabolite test system.

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