# K130811: Psychemedics Microplate Eia for Amphetamine

- Pathway: 510(k) (Traditional)
- Applicant: Psychemedics Corp.
- Decided: May 2, 2013 after 38 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- 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 K933052 (1993). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033743: Cozart Eia Amphetamines Oral Fluid Microplate Kit, Cozart Bioscience, Ltd. (2004) Summary page 1.

## Most influential descendants
- K210212: Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair (2021), 0 descendants of its own

## Indications for use
The Psychemnedics Microplate ETA for Amphetamine is an enzyme immunoassay (ELA) for the preliminary qualitative detection of amphetamine in human head and body hair using an amphetamine calibrator at 3 ng /10 mg hair cutoff for the purpose of identify'ing amphetamine use. This is an in vitro diagnostic device intended exclusively for Psychemedics use only. Psychemedics has not performed an evaluation of reproducibility at different laboratories. The Psychemedics Microplate ETA amphetamine 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 ((iC/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. Psychemnedics plans to perform this test at one site. Psychemedics has not performed an evaluation of reproducibility at different sites.

Source page: https://510kreport.com/device/K130811
Methodology: https://510kreport.com/methodology