ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE
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 |
Indications for 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)
