ON CALL MULTI-DRUG HOME TEST

K050050 · ACON Laboratories, Inc. · LDJ · Mar 11, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050050
• Device Name: ON CALL MULTI-DRUG HOME TEST
• Applicant: ACON Laboratories, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Mar 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is a screening test for the rapid detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in urine at a designated cut-off concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. The test is intended for over-the-counter (OTC) consumer use. This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Story

Single-use lateral flow immunochromatographic cassette; detects drugs of abuse in urine. User adds urine via dropper; competitive binding principle; drug presence below cutoff allows antibody-coated particles to bind immobilized conjugate, forming colored line. Absence of line indicates drug presence above cutoff. Control line confirms sample volume. Visually read by consumer at home. Preliminary positive results require laboratory confirmation via GC/MS; materials for confirmation provided with device. Benefits include rapid, accessible preliminary screening for drug presence.

Clinical Evidence

Consumer study (n=503) evaluated accuracy and interpretation. Participants tested spiked urine samples at 0%, 50%, 75%, 125%, 150%, and 200% of target concentrations. Results showed high correct interpretation rates; incorrect interpretations were limited to samples within ±25% of cutoff. 99.8% of participants reported the test was easy to interpret.

Technological Characteristics

Lateral flow immunochromatographic cassette; competitive binding principle. Plastic housing with test strip and sample dropper. Visual readout. No electronic components or instrumentation required. Qualitative assay.

Indications for Use

Indicated for OTC screening of urine for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in consumers. Provides preliminary results; requires GC/MS confirmation.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid 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

• ACON One Step Multi-Drug Multi-Line Screen Test (K020313)

Submission Summary (Full Text)

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#### 510(k) SUMMARY 10.

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Assigned 510(k) number is K050050

# Submitter:

ACON Laboratories, Inc. 4108 Sorrento Valley Boulevard San Diego, California 92121

Tel.: [phone] Fax: [phone]

# Date:

January 7, 2005

# Contact Person:

Edward Tung, Ph.D.

# Product Names:

On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine

# Common Name:

Immunochromatographic test for the qualitative detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in urine.

# Regulation Name:

Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine test system.

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## Product Code:

LDJ, DIO, DKZ, LAF, DJG, LCM

#### Classification Number:

21 CFR 862.3870, 21 CFR 862.3250, 21 CFR 862.3100, 21 CFR 862.3610, 21 CFR 862.3650

## Device Classification:

The Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine test systems have been classified as Class II devices with moderate complexity. The On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is similar to another FDA-cleared device (ACON One Step Multi-Drug Multi-Line Screen Test, K020313) for the qualitative detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in urine specimens. This test is used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis.

# Statement of Intended Use Compared to Other Products:

The On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is a rapid chromatographic immunoassay for the qualitative detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in urine at a cutoff concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test is used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis. They are intended for the over-the-counter lay person use.

#### Discussion of Technological Characteristics:

The On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is a competitive binding, lateral flow immunochromatographic assay for the qualitative screening of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, Phencyclidine, and their metabolites in urine at a cutoff concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test can be performed without the use of an instrument.

A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Marijuana, Cocaine, Amphetamine,

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Methamphetamine, Opiates, or Phencyclidine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should generate a control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

# Safety and Effectiveness Data:

Because the On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Doctare and Phencyclidine is identical to the ACON One Step Multi-Drug Multi-Line Screen Test Card/Device that is legally marketed under K020313 for professional use, and because no special skills, training, education, or licensing is required to transfer a few drops of a urine sample into the test card well, there is no issue regarding the safety or effectiveness of the product to perform its intended function, i.e., to screen urine for the presence or absence of THC, COC, AMP, mAMP, OPI, PCP, and their metabolites. Because the labeling of the On Call™ රටට, Thin, Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the First Check® Home Drug Test and the Phamatech At Home™ Drug Test, and there have been no reports of consumer inability to follow instructions or interpret results over the many months these products have been purchased, it should be concluded that the product can be used effectively by the lay user.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR í 1 2005

Edward Tung, Ph.D. Regulatory Affairs ACON Laboratories, Inc. 4108 Sorrento Valley Blvd San Diego, CA 92121

k050050 Re:

KU50050
Trade/Device Name: On Call™ Multi-Drug Home Test for Marijuala, Cocaine, On Call Call - ine, Methamphetamine, Opiates, and Phencyclidine Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Roganat Code: DKZ, DIO, LDJ, LCM, DJG, LAF Dated: January7, 2005 Received: January 10, 2005

Dear Dr. Tung:

We have reviewed your Scction 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrease) to regary to regary the Medical Device Amendments, or to commerce provision in accordance with the provisions of the Federal Food, Drug, devices that have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general bonurely provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (sec above) into either class II (Special Controls) or class III (PMA), it your device is etablified (bos are royarols. Existing major regulations affecting your device it may be subject to Sater additions (CFR), Parts 800 to 895. In additions (CFR), Parts 800 to 895 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 i toast oc advisod that I Drivination that your device complies with other requirements of the Act that I 27 thas made a and regulations administered by other Federal agencies. You must or any I catal statutes and reguirements, 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) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you w ought inding of substantial equivalence of your device to a legally premarket notification: "The 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 note the 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 I ou thay other butter getarers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sean M. Cooper MS, DUM

Jean M. Cooper, MS, D.V.M. 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 13.

# 510(k) Number (if known):

# Device Name: On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine

# Indications for Use:

Cocaine, Amphetamine, Home Test for Marijuana, The On Call™ Multi-Drug The On Call - Childer Drag - Rencyclidine is a screening test for the rapid detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in urine at Marjuana, Cocaine, Ampticaliano, MSO ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 a designator our off venestamine, 1,000 ng/mL for Methamphetamine, 2,000 ng/mL for Opiates, and ng int' for Thencyclidine. The test is intended for over-the-counter (OTC) consumer use.

This assay provides only a preliminary analytical test result. A more specific alternate This assay provise must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

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

Over-The-Counter Use x (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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of

510(k) K050050