# K011962: Advantage Marijuana (THC) and Cocaine Home Drug Test

- Pathway: 510(k) (Traditional)
- Applicant: Advantage Diagnostics Corp.
- Decided: Aug 9, 2001 after 48 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Phamatec QuickScreen™ At Home Test: named in the summary without a submission number

## Indications for use
The Advantage Marijuana (THC) and Cocaine Home Drug Test is a qualitative, one step, immunochromatographic competitive assay used to screen human-urine for the presence of cannabinoids at a cut off concentration of 50ng/mL and benzoylecgonine at a cut off of 300ng/mL. The test is the first part of a two-step process to provide consumers with information regarding the presence or absence of THC and/or Cocaine. Confirmation, using GC/MS, of a possible Marijuana(THC) and/or Cocaine result is recommended as the second step.

Source page: https://510kreport.com/device/K011962
Methodology: https://510kreport.com/methodology