# K123799: Psychemedics Microplate Eia for Oxycodone in Hair

- Pathway: 510(k) (Traditional)
- Applicant: Psychemedics Corp.
- Decided: Feb 8, 2013 after 60 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: 1 generation back to K014101 (2002). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 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 1.

## Most influential descendants
- K201326: Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair (2021), 0 descendants of its own

## Indications for use
The Psychemnedics Microplate EIA for Oxycodone is an enzyme immunoassay (EIA) for the preliminary qualitative detection of oxycodone in human head and body hair using a oxycodone calibrator at 2 ng /10 mg hair cutoff for the purpose of identifying oxycodone use. This is an in vitro diagnostic device intended exclusively for Psychemnedics use only and is not intended for sale to anyone. The Psychemnedics Microplate ETA oxycodone assay provides only a preliminary analytical test 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 or LC/MS/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 result is positive. Psychemedics plans to perform this test at one site. Psychemnedics has not performed an evaluation of reproducibility at different sites.

Source page: https://510kreport.com/device/K123799
Methodology: https://510kreport.com/methodology