# K201228: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

- Pathway: 510(k) (Traditional)
- Applicant: Psychemedics Corporation
- Decided: Jun 25, 2021 after 414 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: 2 generations back to K010868 (2001). 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)
- K111925: Psychemedics Cocaine Eia, Psychemedics Corp. (2012) Summary page 4.

## Indications for use
The Psychemedics homogeneous enzyme immunoassay for cocaine in hair is an enzyme immunoassay for the preliminary qualitative detection of cocaine in human head and body hair using a cocaine calibrator of 5 ng/10 mg hair for the purpose of identifying cocaine use. This product is intended exclusively for in-house professional use and not for sale to anyone. The Psychemedics EIA Cocaine Assay provides only a preliminary analytical test result. To confirm positive results, a more specific alternate chemical method (e.g. LC/MS/MS) must be used. Clinical consideration and professional judgement should be applied to the interpretation of any drug-of-abuse test result.

Source page: https://510kreport.com/device/K201228
Methodology: https://510kreport.com/methodology