'RapidOne-OXY' Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. 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. gaschromatography/mass spectrometry (GC/MS.)

'RapidOne-OXY' Test provides only a preliminary analytical result. A more specific alternate chemical method must be used in order to obtain a more confirmed result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used.

Device Description

The assay employed in the 'RapidOne-OXY' 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 that 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 a membrane. In the absence of any drug in the urine sample, the colloidal goldantibody 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 or absence of drug in the urine, and therefore, should be present in all reactions.

AI/ML Overview

Here's an analysis of the acceptance criteria and study details for the 'RapidOne-OXY' Test based on the provided text:

Acceptance Criteria and Device Performance for 'RapidOne-OXY' Test

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Detection of Oxycodone	Detects 100 ng/ml of oxycodone in urine.
Qualitative Screening	Provides a preliminary qualitative result for oxycodone in human urine.
Agreement with GC/MS (Negative Samples)	Correctly identified all 50 drug-free samples as negative.
Agreement with GC/MS (Positive Samples)	Identified positive specimens (ranging from 54 to 1025 ng/ml) as positive.
Reproducibility with No Drug Present	80/80 (100%) negative results.
Reproducibility at 50 ng/ml	8/80 (10%) positive, 72/80 (90%) negative results.
Reproducibility at 75 ng/ml	65/80 (81.25%) positive, 15/80 (18.75%) negative results.
Reproducibility at 100 ng/ml (Cut-off)	80/80 (100%) positive results.
Reproducibility at 125 ng/ml	80/80 (100%) positive results.

Note on Acceptance Criteria: The document primarily describes the intended performance and target detection limit, rather than explicit, pre-defined quantitative acceptance criteria with specific thresholds for sensitivity, specificity, or agreement. The "Reproducibility" table shows data around the cut-off, which implicitly demonstrates expected performance at and around that threshold. However, specific percentage targets for "acceptable" performance at these concentrations are not stated. The overall conclusion states "substantially equivalent to GC/MS," which is the overarching acceptance criterion for 510(k) clearances.

2. Sample Size and Data Provenance

Test Set Sample Size: 90 samples (50 drug-free, 40 positive).
Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in nature, as samples were "selected for evaluation" and "tested as positive by Syva Emit II" and "confirmed as positive and quantified by GC/MS" prior to testing with the 'RapidOne-OXY' device.

3. Number and Qualifications of Experts for Ground Truth

Not applicable. The ground truth was established by laboratory methods (Syva Emit II and GC/MS), not by human experts.

4. Adjudication Method for the Test Set

Not applicable. Ground truth was established by laboratory methods (Syva Emit II and GC/MS), not requiring human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test, not a medical imaging or diagnostic aid device that typically involves human readers assisted by AI. The study directly compares the device's performance to a reference standard (GC/MS).

6. Standalone Performance Study

Yes, a standalone performance study was done. The described performance characteristics directly evaluate the 'RapidOne-OXY' Test's ability to detect oxycodone in urine independently against a reference standard (GC/MS) and its reproducibility.

7. Type of Ground Truth Used

Laboratory Reference Standard:
- GC/MS (Gas Chromatography/Mass Spectrometry): This was the primary confirmatory and quantitative method used to establish the true oxycodone concentrations in the positive samples.
- Syva Emit II: Used to initially identify the 40 positive samples before GC/MS confirmation and quantification.

8. Sample Size for the Training Set

Not applicable / Not explicitly stated. This device is an immunoassay (an antibody-based test), not a machine learning or AI-driven algorithm that typically requires a distinct "training set" in the context of device performance studies. The development of the assay itself would involve optimization and testing, but the provided documentation focuses on the validation of the finished product against a reference standard.

9. How Ground Truth for the Training Set Was Established

Not applicable. As noted above, there isn't a traditional "training set" in the context of AI/ML for this immunoassay. The development of the specific antibodies and the assay format would have been based on established biochemical principles and experimental validation during product development, but this isn't detailed as a specific "training set" for performance evaluation.

Summary

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MAR 2 0 2002

K01401

510(k) Summary

Submitter's Name/Address:

American Bio Medica Corporation 122 Smith Road Kinderhook, NY 12106

Contact Person:

Henry Wells VP Product Development Phone: 518 758 8158 Fax: 518-758 8171

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common/Usual Name or Classification Name:

December 12, 2001

'RapidOne-OXY' Test

Oxycodone test system

Classification Number/Class

[no classification regulation]/ClassII

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

The assigned 510(k) number is:

Predicate Device: The technology utilized in 'RapidOne'-OXY Test is the same as that utilized in the RDS opiate test products.

Test Description:

The assay employed in the 'RapidOne-OXY' Test is based on the same principle of highly specific reaction between antigens and antibodies.

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

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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.

Intended use:

'RapidOne-OXY' Test is used for the qualitative detection of oxycodone 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., GC/MS.

Performance Characteristics:

'RapidOne-OXY' Test will detect 100 ng/ml of oxycodone in urine.

'RapidOne-OXY' Test was compared to GC/MS 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 as positive and quantified by GC/MS. 'RapidOne-OXY' Test correctly identified all the specimens that contained no drug as negative. Specimens, ranging in concentration of 54 to 1025 ng/ml, were shown to be positive by 'RapidOne-OXY' test. Two specimens containing 40 and 43 ng/ml of oxycodone were determined as negative by 'RapidOne-OXY' test.

Reproducibility was evaluated using control urines containing methadone concentrations above and below the stated cut-off. Forty (40) replicates were run at each concentration by three different operators.

Concentration(ng/ml)	#	RDS Result
		Pos	Neg
No drug	80	0	80
50	80	8	72
75	80	65	15
100	80	80	0
125	80	80	0

Conclusion:

'RapidOne-OXY' Test obtains results substantially equivalent to GC/MS.

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Image /page/2/Picture/0 description: The image shows a circular logo for the Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized lines that resemble a human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged around the perimeter of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 2 0 2002

Mr. Henry Wells VP Product Development American Bio Medica Corporation 122 Smith Road Kinderhook. NY 12106

K014101 Re:

Trade/Device Name: RapidOne-OXY Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: DJG Dated: February 12, 2002 Received: February 13, 2002

Dear Mr. Wells:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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 International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.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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Kol4101 510(k) Number (if known):

Device Name: RapidOne-OXY' Test

Indications For Use:

'RapidOne-OXY' Test is a one-step, lateral flow immunoassay for the detection of oxycodone in urine.

'RapidOne-Oxy' Test is intended for the qualitative detection of oxycodone in human urine at 100 ng/ml.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sand

(Division Sign-Off) Division of Clinical Laboratory L svices 510(k) Number_16014 | 0 \

Prescription Use
X
(Per 21 CFR 801.109)

Over-The-Counter Use

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).