510(k) · Cleared

Cleared

Psychemedics Cocaine Eia

K111925510(k) TraditionalCleared May 1, 2012300-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 Corp. · JXO Enzyme Immunoassay, Cocaine

Cleared on May 1, 2012 as substantially equivalent to K010868 (Psychemedics Corp., 2001) after a 300-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: May 1, 2012
Review: 300 days
Class: Class II
Product code: JXO
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010868 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK010868 Psychemedics Ria Cocaine AssayPsychemedics Corp. · 2001
This deviceK111925 Psychemedics Cocaine EiaPsychemedics Corp. · 2012
Descendant · cites it directly · 0 of its ownK201228 Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics Corporation · 2021

Most influential descendants

Showing 1 of 1 · See all

K201228Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in HairPsychemedics Corporation · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K111925, 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.

Top candidate predicates for a new JXO device

#1 K201228 Psychemedics Homogeneous Enzyme Immunoassay…score 1.9 · 2 generations · no Class I recall

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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
*	K010868	Psychemedics Ria Cocaine Assay Summary page 1 …: April 25, 2012 Device Trade Name: Psychemedics Microplate EIA for Cocaine in Hair Predicate Device: Psychemedics Cocaine Assay, k010868 Product Code: JXO Device Classification/Name: 21 CER 862.3250; Enzyme Immunoassay, Cocaine;…	Psychemedics Corp.	2001	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K201228	Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair	Psychemedics Corporation	2021	0

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?

Its one ancestor has no recall.
Of its descendants, K201228 (Psychemedics Corporation, 2021) has gone furthest, with 0 descendants of its own.

How does its category compare?

All JXO devices

JXO Enzyme Immunoassay, Cocaine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 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…

Read the full statement (115 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K111925 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111925: Psychemedics Cocaine Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111925

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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