ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE

K050936 · ACON Laboratories, Inc. · LDJ · Jun 24, 2005 · Clinical Toxicology

Device Facts

• Record ID: K050936
• Device Name: ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
• Applicant: ACON Laboratories, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Jun 24, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The On Call™ Home Drug Test for Marijuana (THC) is only the first step in a two-step process for determining the presence of the THC in human urine. The On Call™ Home Drug Test for Marijuana (THC) and Cocaine (COC) is only the first step in a two-step process for determining the presence of the marijuana and cocaine in human urine. The On Call Home Drug Test for Marijuana is a screening test for the rapid detection of Marijuana (THC) and its metabolites in urine at a designated cut-off concentration of 50 ng/mL for Marijuana (THC). The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided. 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. The On Call Home Drug Test for Marijuana & Cocaine is a screening test for the rapid detection of Marijuana (THC), Cocaine (COC) and their metabolites in urine at a designated cut-off concentration of 50 ng/mL for Marijuana (THC) and 300 ng/mL for Marijuana & Cocaine (THC, COC). The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence of THC, COC or their metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided. 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

Lateral flow immunochromatographic assay; detects THC and/or COC metabolites in urine. Principle: competitive binding antigen-antibody immunochemistry; mouse monoclonal antibodies. Input: urine sample; Output: visual colored-line in test region (negative) or absence of line (positive); control line confirms proper wicking. Used by lay consumers in home setting; no instrumentation required. Provides preliminary screening; positive results require laboratory GC/MS confirmation. Benefits: rapid, accessible drug screening for consumers.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological identity to predicate devices and established performance of lateral flow immunoassay methodology for drug screening.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Mouse monoclonal antibodies. Cut-offs: 50 ng/mL (THC), 300 ng/mL (COC). Visual readout (colored lines). No instrumentation required. Standalone test device.

Indications for Use

Indicated for OTC consumer use for rapid qualitative screening of Marijuana (THC) and/or Cocaine (COC) metabolites in urine. Cut-offs: 50 ng/mL (THC), 300 ng/mL (COC). Preliminary result only; 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

• Accu-Stat™ Home Drug Test for Marijuana (THC), or Marijuana & Cocaine (THC, COC) (K040327)
• ACON THC One Step Marijuana Test Device (K003557)
• ACON One Step Multi-Drug Multi-Line Screen Test Card/Device (K020313)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 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.

K050936 The Assigned 510(k) number is

# Submitter:

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

Tel.: [phone] Fax: [phone]

# Date:

April 13, 2005

### Contact Person:

Edward Tung, Ph.D.

### Product Names:

On Call® Home Drug Test for Marijuana

On Call® Home Drug Test for Marijuana and Cocaine

### Common Name:

Immunochromatographic test for the qualitative detection of Marijuana, or Marijuana and Cocaine in urine.

### Regulation Name:

Marijuana, or Marijuana and Cocaine test system.

{1}------------------------------------------------

# Product Code:

LDJ, DIO

# Classification Number:

21 CFR 862.3870, 862.3250

# Device Classification:

The Marijuana and Cocaine test systems have been classified as Class II devices. The On Call Home Drug Test for Marijuana and the On Call Home Drug Test for Marijuana & Cocaine are similar to two FDA-cleared devices for the qualitative detection of Marijuana, or Marijuana and Cocaine in urine specimens. These tests are 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 Home Drug Tests for Marijuana (THC), or Marijuana & Cocaine (THC, COC) are rapid lateral flow immunoassays for the qualitative detection of Marijuana and Cocaine in urine at cutoff concentrations of 50 ng/mL for Marijuana and 300 ng/mL for Cocaine. These tests are 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 Home Drug Tests for Marijuana (THC), or Marijuana & Cocaine (THC, COC) are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Marijuana, or Marijuana and Cocaine 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 (THC) and 300 ng/mL for Cocaine (COC). These tests 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, or Marijuana and Cocaine 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 always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

{2}------------------------------------------------

#### Safety and Effectiveness Data:

Because the On Call Home Drug Test for Marijuana and the On Call Home Drug Test for Marijuana & Cocaine are identical to the Accu-Stat™ Home Drug Test for Marijuana (THC), or Marijuana & Cocaine (THC, COC) (K040327) that is legally marketed for over-the-counter use, and the ACON THC One Step Marijuana Test Device (K003557) and the ACON One Step Multi-Drug Multi-Line Screen Test Card/Device (K020313) that are legally marketed 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 device 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, or THC & COC and its/their metabolite(s). The labeling of the On Call Home Drug Tests for Marijuana (THC), or Marijuana & Cocaine (THC, COC) is similar to a variety of rapid screening tests currently in commercial distribution in the U.S., including the First Check® Home Drug Tests and the Phamatech At Home™ Drug Tests. 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 a lay user.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized human figure with outstretched arms, representing health and well-being. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged in a circular fashion. The text is in all capital letters and is evenly spaced around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 2 4 2005

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

Re: k050936

Trade/Device Name: On Call® Home Drug Test for Marijuana On Call® Home Drug Test for Marijuana & Cocaine Regulation Number: 21 CFR 862.3870 Regulation Name: Cannabinoid test system Regulatory Class: Class II Product Code: LDJ, DIO Dated: April 13, 2005 Received: April 14, 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).

{4}------------------------------------------------

#### Page 2 -

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, 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 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 yours,

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

{5}------------------------------------------------

#### INDICATIONS FOR USE 13.

510(k) Number (if known): K0509360

On Call® Home Drug Test for Marijuana Device Name:

Indications for Use:

The On Call Home Drug Test for Marijuana is a screening test for the rapid detection of Marijuana (THC) and its metabolites in urine at a designated cut-off concentration of 50 ng/mL for Marijuana (THC). The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

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

X 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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of _ 2

510(k) K050936

{6}------------------------------------------------

#### INDICATIONS FOR USE 14.

510(k) Number (if known): KOS093Lo

On Call® Home Drug Test for Marijuana & Cocaine Device Name:

Indications for Use:

The On Call Home Drug Test Marijuana & Cocaine is a screening test for the rapid detection of Marijuana (THC), Cocaine (COC) and their metabolites in urine at a designated cut-off concentration of 50 ng/mL for Marijuana (THC) and 300 ng/mL for Marijuana & Cocaine (THC, COC). The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence of THC, COC or their metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

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)

(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

Page 2 of 2

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K050936