ON CALL MULTI-DRUG HOME TEST CUP

K050878 · ACON Laboratories, Inc. · LDJ · Jun 8, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050878
• Device Name: ON CALL MULTI-DRUG HOME TEST CUP
• Applicant: ACON Laboratories, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The On-Call™ Multi-Drug Home Test Cup is a screening test for the rapid detection of drugs 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, 500 ng/mL for Ecstasy, 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

Device is a lateral flow immunoassay cup for qualitative drug screening in urine. Input: urine specimen. Principle: competitive binding immunochromatography using mouse monoclonal antibodies. Output: visual colored lines in test region (negative) or absence of lines (positive); procedural control line confirms proper wicking. Used by lay persons in home settings. Results are preliminary; positive findings require professional GC/MS confirmation. Benefit: provides rapid, accessible preliminary screening for drug presence.

Clinical Evidence

No clinical data. Bench testing only; device performance is established through analytical validation of cutoff concentrations and comparison to the predicate device.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle; mouse monoclonal antibodies; visual readout; no instrumentation required; standalone test cup.

Indications for Use

Indicated for OTC consumer use for rapid qualitative screening of Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates, and Phencyclidine in urine. 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 Spectrum Multi-Drug Multi-Line Drug Screen Test (K031759)

Reference Devices

• Phamatech rapid screening test

Submission Summary (Full Text)

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#### 10. 510(k) SUMMARY

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 1050878

# Submitter:

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

Tel.: [phone] Fax: [phone]

# Date:

April 4, 2005

# Contact Person:

Edward Tung, Ph.D.

# Product Names:

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

## Common Name:

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

## Regulation Name:

Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, 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, Ecstasy, Opiates, and Phencyclidine test systems have been classified as Class II devices with moderate complexity. The On-Call™ Multi-Drug Home Test Cup is similar to another FDA-cleared device (ACON Spectrum Multi-Drug Multi-Line Drug Screen Test, K031759) for the qualitative detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, 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 Cup is a rapid lateral flow immunoassay for the qualitative detection of drugs 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, 500 ng/mL for Ecstasy, 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-thecounter lay person use.

#### Discussion of Technological Characteristics:

The On-Call™ Multi-Drug Home Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative screening of Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, 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 drugs, 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, 500 ng/ml for Ecstasy, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test can be performed without the use of an instrument.

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A drug-positive urine specimen will not generate colored-lines in the designated test region, while A urine specimen or a urine specimen containing Marijuana, Cocaine, Amphetamine, a megative anne specimen or a anno epididine at the concentration below the cutoff level will generate colored-lines in the test region. To serve as a procedural control, a colored-line whit generate control miss in antol 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 Cup is identical to the ACON Key Cup (K031759) that is legally marketed for professional use; and because no special skills, training, education, or that is legarry marketed for percession 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, MDMA, OPI, PCP, and Screen unne for the probeiles of acce. Call™ Multi-Drug Home Test Cup is similar to a variety then measonner - 11-5 x wently in commercial distribution in the U.S., including the Phamatech or rapid soroming test. There have been no reports of consumer inability to follow instructions or interpret results over the many months these products have been marketed, it should be concluded that the product can be used effectively by a lay user.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Public Health Service

JUN 8 - 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k050878

Trade/Device Name: On-Call™ Multi-Drug Home Test Cup for Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, Opiates and Phencyclidine Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DIO, DKZ, LAF, DJG, LCM Dated: April 4, 2005 Received: April 6, 2005

Dear Dr. Tung:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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) 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 information about the application of labeling requirements to your device, rr you stions 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 Division of Small Manufacturers, 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 vours.

Carol C. Benam

Carol C. Benson, M.A. Acting 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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#### 13. INDICATIONS FOR USE

510(k) Number (if known): K050878

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

Indications for Use:

The On-Call™ Multi-Drug Home Test Cup is a screening test for the rapid detection of drugs 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, 500 ng/mL for Ecstasy, 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.

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

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

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

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510(k) KD50878