# K131168: Immunalysis Oxycodone Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Immunalysis Corporation
- Decided: Jan 17, 2014 after 268 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.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
The Immunalysis Oxycodone Urine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a dual cutoff of 100ng/mL and 300ng/mL. The assay is intended for use in laboratories for the qualitative and semi-quantitative analysis of Oxycodone in human urine with automated clinical chemistry analyzers. This assay is calibrated against Oxycodone. This in-vitro device is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GC-MS or permitting laboratories to establish quality control procedures. The Immunalysis Oxycodone Urine Enzyme Immunoassay Kit 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) or Liquid Chromatography/Mass Spectroscopy (LC/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. The Immunalysis Oxycodone Urine Controls are used as control materials in the Immunalysis Oxycodone Urine Enzyme Immunoassay. The Immunalysis Oxycodone Urine Calibrators are used as calibrators in the Immunalysis Oxycodone Urine Enzyme Immunoassay for the qualitative and semi-quantitative determination of Oxycodone in urine on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K131168
Methodology: https://510kreport.com/methodology