# K050936: ON Call Home Drug Test for Marijuana and on Call Home Drug Test for Marijuana and Cocaine

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Jun 24, 2005 after 71 days
- Product code: LDJ (Enzyme Immunoassay, Cannabinoids)
- Device class: 2
- Regulation: 21 CFR 862.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945610 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040327: Accu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana & Cocaine (THC, Coc), Accu-Stat Diagnostics, Inc. (2004) Summary page 3.
- K003557: Acon THC One Step Marijuana Test Strip (Urine);Acon THC One Step Marijuana Test Device (Urine), ACON Laboratories, Inc. (2001) Summary page 3.
- K020313: Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test Device, Acon Laboratories Co. (2002) Summary page 3.

## 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. 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.

Source page: https://510kreport.com/device/K050936
Methodology: https://510kreport.com/methodology