# K040411: Dri Oxycodone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: May 27, 2004 after 99 days
- Product code: LAS (Drug Specific Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K014101 (2002). 1 ancestor in all.
16 later devices descend from it; 4 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014101: Rapidone-Oxy Test, American Bio Medica Corp. (2002) Summary page 3.

## Most influential descendants
- K060351: Medtox Oxycodone (2006), 6 descendants of its own
- K050733: Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls (2005), 6 descendants of its own
- K120763: Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls (2012), 5 descendants of its own
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System (2009), 4 descendants of its own
- K141055: Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML) (2014), 3 descendants of its own

## Indications for use
The DRI® Oxycodone Assay is intended to be used for the qualitative and semi-quanilitative determination of the presence of oxycodone in human urine at cutoffs of 100 and 300 ng/mL. The assay provides a simple and rapid analytical screenlng procedure to detect oxycodone in human urine. The assay provides only a preliminary analytical test resuilt. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography /mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. The DRI® Oxycodone Calibrators are used to calibrate the DRI® Oxycodone Assay in human urine. The DRI® Oxycodone Controls are used to qualify the DRI® Oxycodone Assay in human urine.

Source page: https://510kreport.com/device/K040411
Methodology: https://510kreport.com/methodology