RAPIDONE-AMPHETAMINE TEST

K992452 · American Bio Medica Corp. · DOD · Oct 18, 1999 · Clinical Toxicology

Device Facts

• Record ID: K992452
• Device Name: RAPIDONE-AMPHETAMINE TEST
• Applicant: American Bio Medica Corp.
• Product Code: DOD · Clinical Toxicology
• Decision Date: Oct 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

'RapidOne' - Amphetamine Test is a one-step, lateral flow immunoassay for the detection of amphetamine in urine. 'RapidOne' - Amphetamine Test is intended for use in the qualitative detection of amphetamine in human urine at 1000 ng/ml. 'RapidOne' - Amphetamine 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' - Amphetamine 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 Story

RapidOne-Amphetamine Test is a lateral flow, one-step immunoassay for qualitative detection of d-amphetamine in human urine. Device consists of a membrane strip with immobilized anti-amphetamine monoclonal antibody and a reagent pad containing colloidal gold-BSA-amphetamine conjugate. Principle of operation: competitive immunoassay; drug in urine competes with immobilized drug conjugate for limited antibody binding sites. Negative result: visible line in test area (antibody-antigen reaction). Positive result: absence of color band in test area (drug saturates binding sites). Control line confirms proper flow. Used by professionals in clinical settings for preliminary screening; results require confirmation via GC/MS. Provides rapid, preliminary analytical data to guide clinical decision-making regarding further testing.

Clinical Evidence

Bench testing only. Performance evaluated against Syva EMIT-II using 90 urine samples (50 drug-free, 40 positive). All 40 positive samples were confirmed via GC/MS (range 750-58,000 ng/ml). Both immunoassays correctly identified all negative and positive specimens. Reproducibility testing performed over 5 days at concentrations of 0, 500, 750, 1000, and 1250 ng/ml showed consistent results at the 1000 ng/ml cutoff.

Technological Characteristics

Lateral flow immunoassay; membrane strip with immobilized anti-amphetamine monoclonal antibody; colloidal gold-BSA-amphetamine conjugate reagent pad. Qualitative visual readout. No external energy source required. Standalone test device.

Indications for Use

Indicated for qualitative detection of d-amphetamine in human urine at a 1000 ng/ml cutoff. Intended for professional use only; not for over-the-counter sale. Provides preliminary screening results requiring confirmation by GC/MS.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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).

Predicate Devices

• Instacheck - Drug Screen - Amphetamine Test
• Forefro Amphetamine Test

Reference Devices

• Syva EMIT-II

Submission Summary (Full Text)

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K992452

## 510(k) Summary

Submitter's Name/Address: American Bio Medica Corporation 122 Smith Road Kinderhook, N.Y. 12106

OCT 18 1999

Contact Person: Henry Wells Vice President of Product Development Phone: [phone] Fax: [phone]

Date of Preparation of this Summary:

September 24, 1999

Device Trade of Proprietary Name:

Device Common/Usual Name or Classification Name:

'RapidOne'-Amphetamine Test

Amphetamine test system

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:

# Predicate Device: Forefro Amphetamine Test (510(k) No

## Test Description:

The assay employed in the 'RapidOne' - Amphevamine 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 couplex 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 conta the immobilized drug antibody. An autibody-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 volloidal 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

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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 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.

### Intended Use:

'RapidOne' - Amphetamine Test is used for the qualitative detection of d-amphetamine 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'-Amphetamine Test will detect 1000 ng/ml of d-amphetamine in urine.

'RapidOne'-Amphetamine Test was compared to EMIT II. 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 750 ng/ml to 58,000 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 |
|---------------|----|-----------|
| 0 | 40 | 40/40 neg |
| 500 | 40 | 5/40 pos |
| 750 | 40 | 30/40 pos |
| 1000 | 40 | 40/40 pos |
| 1250 | 40 | 40/40 pos |

#### Conclusion:

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 18 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: K992452

Trade Name: 'Rapid One' - Amphetamine Test Regulatory Class: II Product Code: DKZ, DOD Dated: July 22, 1999 Received: July 22, 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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## Page 2

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrlvdsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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510(k) Number (if known): K993452

'RapidOne' - Amphetamine Test Device Name:

Indications For Use:

'RapidOne' - Amphetamine Test is a one-step, lateral flow immunoassay for the detection of amphetamine in urine. 'RapidOne' - Amphetamine Test is intended for use in the qualitative detection of amphetamine in human urine at 1000 ng/ml.

'RapidOne' - Amphetamine 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' - Amphetamine 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.

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Tivision Sign-O---------------------------------------------------------------------------------------------------------------------------------------------------------------510(k) Numbe

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription_Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)