# K050733: Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jun 13, 2005 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; 1 cites 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
- K120763: Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls (2012), 5 descendants of its own
- K141055: Lzi Hydrocodone; Enzyme Immunoassay, Calibrators; (5ML), (15ML); Controls; (5ML), (15ML) (2014), 3 descendants of its own
- K150502: DRI Hydrocodone Assay, DRI Hydrocodone Calibrators,  DRI Hydrocodone Controls (2015), 2 descendants of its own
- K231752: ARK Hydrocodone Assay (2023), 0 descendants of its own
- K202007: LZI Oxycodone III Enzyme Immunoassay (2020), 0 descendants of its own

## Indications for use
The Oxycodone Enzyme Immunoassay is a homogeneous enzyme immunoassay with 100 and 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semi-quantitative analyses of oxycodone and its metabolite, oxymorphone in human urine. The Oxycodone calibrators are used to calibrate the oxycodone enzyme immunoassay for drug detection in human urine. The Oxycodone controls are used to validate the assay. The assay provides a simple and rapid analytical screening procedure to detect oxycodone and its metabolite in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. Performance data submitted was obtained using the Hitachi 717 analyzer. The Oxycodone Enzyme Immunoassay provides only a preliminary analytical test result. 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 consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K050733
Methodology: https://510kreport.com/methodology