# K060810: One Step Drug Test - Amp/Met/Mor/THC/Coc

- Pathway: 510(k) (Traditional)
- Applicant: Ind Diagnostic, Inc.
- Decided: Aug 7, 2006 after 136 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The One Step Drugs of Abuse Test is a prescription lateral flow competitive immunoassay panel or single test intended for professional central laboratory use by trained users. It provides qualitative visual screening results for Marijuana, Cocaine, Morphine, Amphetamine and Methamphetamine at cutoff concentrations of 50 ng/mln Marijuana, 300 ng/mL Cocaine, 300 ng/mL Morphine, 1000 ng/mL Amphetamine and 1000 ng/mL Methamphetainine in urine in combinations (Multi-Panel) or separately (Single). It is not intended for over the counter sales to the lay person. For in vitro diagnostic use only. As with all qualitative tests, this assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method

Source page: https://510kreport.com/device/K060810
Methodology: https://510kreport.com/methodology