# K111925: Psychemedics Cocaine Eia

- Pathway: 510(k) (Traditional)
- Applicant: Psychemedics Corp.
- Decided: May 1, 2012 after 300 days
- Product code: JXO (Enzyme Immunoassay, Cocaine)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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 K010868 (2001). 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)
- K010868: Psychemedics Ria Cocaine Assay, Psychemedics Corp. (2001) Summary page 1.

## Most influential descendants
- K201228: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (2021), 0 descendants of its own

## Indications for use
The Psychemedics Microplate EIA for Cocaine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cocaine and metabolites in human head and body hair using a cocaine calibrator at 5 ng /10 mg hair cutoff for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use only and is not for sale to anyone. The Psychemedics Microplate EIA for Cocaine in Hair provides only a preliminary analytical test result. To confirm a presumptive screen positive result, a more specific alternate chemical method such as LC/MS/MS (liquid chromatography/mass spectrometry/mass spectrometry) must be used. Clinical consideration and professional judgment should be applied to the interpretation of any drug-of-abuse test result.

Source page: https://510kreport.com/device/K111925
Methodology: https://510kreport.com/methodology