# K172910: Emit II Plus Oxycodone Assay

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Oct 18, 2017 after 23 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 4.

## Indications for use
The Emit II Plus Oxycodone Assay is a homogeneous enzyme immunoassay with 100 ng/mL and 300 ng/mL cutoffs. The assay is intended for in vitro diagnostic use in the qualitative and semiquantitative determination of oxycodone in human urine. The Emit II Plus Oxycodone Assay is designed for use with a number of clinical chemistry analyzers. The semiquantitative mode is for the purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/Mass Spectrometry (LC/MS) or permitting laboratories to establish quality control procedures. The Emit II Plus Oxycodone Assay provides only a preliminary analytical test result. A more specific alternative chemical method(s) must be used to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) and LC/MS are the preferred confirmatory methods. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Source page: https://510kreport.com/device/K172910
Methodology: https://510kreport.com/methodology