# K060351: Medtox Oxycodone

- Pathway: 510(k) (Traditional)
- Applicant: Medtox Diagnostics, Inc.
- Decided: May 12, 2006 after 88 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K014101 (2002). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040411: Dri Oxycodone Assay, Microgenics Corp. (2004) Summary page 1.

## Most influential descendants
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (2009), 4 descendants of its own
- K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (2023), 1 descendant of its own
- K250741: Evidence MultiSTAT DOA Urine MultiPlex (2026), 0 descendants of its own
- K221550: Evidence MultiSTAT DOA Urine MultiPlex (2023), 0 descendants of its own
- K130650: Status DS Oxy (2014), 0 descendants of its own

## Indications for use
The MEDTOX® OXYCODONE Test System uses immunochromatographic test strips for the rapid, qualitative detection of oxycodone in human urine. It is intended for prescription use. The test detects oxycodone at concentrations of 100 ng/mL and above. The MEDTOX® OXYCODONE 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.

Source page: https://510kreport.com/device/K060351
Methodology: https://510kreport.com/methodology