RAPIDONE-COCAINE-150 TEST

K053422 · American Bio Medica Corp. · DIO · Jun 15, 2006 · Clinical Toxicology

Device Facts

• Record ID: K053422
• Device Name: RAPIDONE-COCAINE-150 TEST
• Applicant: American Bio Medica Corp.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Jun 15, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

RapidOne Cocaine 150 Test is a one-step lateral flow immunoassay for the qualitative detection of benzoylecgonine in human urine. RapidOne Cocaine 150 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. The 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 Cocaine 150 Test provides only a preliminary analytical result. A more specific alternative 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.

Device Story

RapidOne-Cocaine-150 Test is a lateral flow immunoassay for detecting benzoyl ecgonine in human urine. Device utilizes membrane strip with immobilized drug conjugate and dried colloidal gold-antibody complex. Principle: competitive immunoassay; in absence of drug, gold-antibody complex binds to conjugate, forming visible test line; in presence of drug, drug competes for antibody sites, preventing test line formation. Control line confirms proper flow. Used by professionals in clinical settings for preliminary screening; results require confirmation via GC/MS. Provides rapid qualitative assessment to guide clinical decision-making regarding drug abuse testing.

Clinical Evidence

Bench testing only. Reproducibility evaluated using control urines with concentrations above and below the 150 ng/ml cut-off. All concentrations verified by GC/MS. Testing performed four times daily for five days. Results confirmed reproducibility of the test performance.

Technological Characteristics

Lateral flow immunoassay; membrane strip with immobilized drug conjugate and colloidal gold-antibody complex. Qualitative visual readout (presence/absence of color bands). No external energy source required; capillary action-based fluidics.

Indications for Use

Indicated for professional use in the qualitative detection of benzoylecgonine in human urine as a preliminary screening method to determine the need for confirmatory testing (e.g., GC/MS).

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• RapidOne-Cocaine Test (K990822)

Submission Summary (Full Text)

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K053422

JUN 16 2006

## 510(k) Summary

# Submitter's Name/Address:

American BioMedica Corporation 122 Smith Road Kinderhook, NY 12106

Date of Preparation of this Summary:

Device Trade or Proprietary Name:

Device Common/Ususal Name or Classification Name:

Classification Number/Class:

## Contact Person:

Henry Wells VP Product Development Phone: [phone] Fax:

December 2, 2005

'RapidOne-Cocaine-150 Test

Cocaine Test System

8862.3250 Class II

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

The assigned 510(k) number is: No. K 053422.

Predicate Device: 'RapidOne'-Cocaine Test (510(k) No. K990822).

#### Test Description:

The assay employed in the 'RapidOne-Cocaine-150 Test is based on the same principle of highly specific reactions between antigens and antibodies.

This assay is a one-step, competitive, immunoassay for the detection of benzoyl ecgonine in human urine. The test device consists of a membrane strip onto which a drug conjugate has been mobilized and 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. Antibody-antigen reactions occur, forming visible lines in the "test" area.

When drug is present in the urine sample, the drug or metabolite will compete with the Drug conjugate in the test area for the limited antibody sites on the colloidal gold-labeled Antibody complex. If sufficient amount of drug is present, it will fill all of the available antibody 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

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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 on all reactions.

A negative urine will produce two colored bands, and a positive sample will produce only one band.

### Intended Use:

'RapidOne'-Cocaine-150 Test is used for the qualitative detection of benzoyl ecgonine in human urine. This immunoassay is a simplified 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-150 Test will detect benzoyl ecgonine at 150 ng/ml.

Reproducibility was evaluated using control urines containing concentrations above and below the stated cut-off. Negative controls were also used. All concentrations were verified by GC/MS. Each sample was tested four times, twice daily, for five days. The results confirmed the reproducibility of the 'RapidOne'-Cocaine-150 Test performance.

#### Conclusion:

'RapidOne'-Cocaine-150 Test is substantially equivalent to the previously cleared 'RapidOne'-Cocaine Test 510(k) No. K990822.

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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 features a stylized eagle-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of a circular border containing the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Henry Wells V.P. Product Development American BioMedica Corp. 9110 Red Branch Road Suite B Columbia, MD 21045

JUN 15 2006

Re: k053422

Trade/Device Name: 'RapidOne'- Cocaine-150 Test Regulation Number: 21 CFR§862.3250 Regulation Name: Cocaine & cocaine metabolite test system Regulatory Class: Class II Product Code: DIO Dated: June 6, 2006 Received: June 7, 2006

Dear Dr. 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, Inting 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 Title 21, Code of Federal Regulations artecting your device
may publich further a 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 At 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS), and good manufacturing practi

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 10gally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please nother regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffree number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Alberto Gatti

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications for Use

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510(k) Number (if known): K O 5 3422

'RapidOne'- Cocaine-150 Test Device Name:

Indications For Use:

'RapidOne'-Cocaine-150 Test is a one-step lateral flow immunoassay for the qualitative detection of benzoyl ecgonine in human urine.

'RapidOne'-Cocaine-150 Test is intended for professional use. It is not intended for over the counter sales to nonprofessionals. The assay to perform, but should not be used without proper supervision. The 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'-Cocaine-150 Test provides only a preliminary analytical result. A more specific alternative 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.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

sion Sign-Off

f In Vitro Diagnostic Device
and Safety
LAS3422

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