510(k) · Cleared

Cleared

Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair

K201228510(k) TraditionalCleared Jun 25, 2021414-day reviewClass II21 CFR 862.3250

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Psychemedics Corporation · JXO Enzyme Immunoassay, Cocaine

Cleared on Jun 25, 2021 as substantially equivalent to K111925 (Psychemedics Corp., 2012) after a 414-day review. Its family tree reaches back 2 generations to 2001.

Decided: Jun 25, 2021
Review: 414 days
Class: Class II
Product code: JXO
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K010868 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010868 Psychemedics Ria Cocaine AssayPsychemedics Corp. · 2001
1 generation backK111925 Psychemedics Cocaine EiaPsychemedics Corp. · 2012
This deviceK201228 Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics Corporation · 2021

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010868	Psychemedics Ria Cocaine Assay	Psychemedics Corp.	2001	—
−1	K111925	Psychemedics Cocaine Eia	Psychemedics Corp.	2012	—
0 (this device)	K201228	Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair	Psychemedics Corporation	2021	—

FIG. 1 — Lineage of K201228, 2001–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JXO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K111925	Psychemedics Cocaine Eia Summary page 4 …ame: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair Predicate Device: Psychemedics Microplate EIA for Cocaine in Hair, k111925 Product Code: JXO Device/Classification Name: 21 CFR 862.3250 Cocaine and Cocaine Metabolite Test S…	Psychemedics Corp.	2012	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 20 years and passes through 2 companies; a new generation was cleared every 10.5 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All JXO devices

JXO Enzyme Immunoassay, Cocaine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.

FDA decisions per year · JXO

1in 2021

2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JXO

Too few JXO 510(k)s in any year since 2007 to give a median.

Recalls per year · JXO

No recall names JXO since 2007.

Adverse event reports per year · JXO

1in 2019

2007high 1 (2019) · low 0 (2007)2025

MAUDE reports naming product code JXO, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	1	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	1
2020	0	—	0
2021	1	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K201228 · printed Nov 6, 2026

Cite this page

510(k) Report. “K201228: Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201228

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026