# K120763: Lzi Oxycodone Homogeneous Enzyme Immunoassay, Lzi Oxycondone Calibrators, Lzi Oxycodone Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Jun 1, 2012 after 80 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: 3 generations back to K014101 (2002). 3 ancestors in all.
5 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)
- K050733: Oxycodone Enzyme Immunoassay and Oxycodone Calibrators and Controls, Lin-Zhi International, Inc. (2005) Summary page 2.

## Most influential descendants
- 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
- K173195: DRI Hydrocodone Assay (2018), 0 descendants of its own

## Indications for use
The LZI Oxycodone Enzyme Immunoassay is intended for the qualitative and semi- quantitative determination of Oxycodone in human urine at the cutoff values of 100 and 300 nglmL. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS and LCMS or (2) permitting laboratories to establish quality control procedures. The LZJ Oxycodone Drugs of Abuse (DAU) Calibrators are for use as calibrators in the qualitative and semi-quantitative calibration of the LZI Oxycodone Enzyme Immunoassay. The LZI Oxycodone Drugs of Abuse (DAU) Controls are for use as assayed quality control materials to monitor the precision of the LZI Oxycodone Enzyme Immunoassay. The assay provides only a preliminary analytical result A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

Source page: https://510kreport.com/device/K120763
Methodology: https://510kreport.com/methodology