510(k) · Cleared

Cleared

Psychemedics Phencyclidine Eia

K111928510(k) TraditionalCleared May 1, 2012300-day reviewClass U

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

Psychemedics Corp. · LCM Enzyme Immunoassay, Phencyclidine

Cleared on May 1, 2012 as substantially equivalent to K011275 (Psychemedics Corp., 2002) after a 300-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it.

Decided: May 1, 2012
Review: 300 days
Class: Class U
Product code: LCM
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011275 (2002). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011275 Psychemedics Ria Phencyclidine AssayPsychemedics Corp. · 2002
This deviceK111928 Psychemedics Phencyclidine EiaPsychemedics Corp. · 2012
Descendant · cites it directly · 0 of its ownK212952 Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine…Psychemedics Corporation · 2022

Most influential descendants

Showing 1 of 1 · See all

K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011275	Psychemedics Ria Phencyclidine Assay	Psychemedics Corp.	2002	—
0 (this device)	K111928	Psychemedics Phencyclidine Eia	Psychemedics Corp.	2012	—
+1	K212952	Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair	Psychemedics Corporation	2022	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K111928, 2002–2022Source: 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 LCM? 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 LCM device

#1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 generations · no Class I recall
#2 Held for the reportin 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
*	K011275	Psychemedics Ria Phencyclidine Assay Summary page 1 …April 25, 2012 Device Trade Name: Psychemedics Microplate EIA for Phencyclidine in Hair Predicate Device: Psychemedics Phencyclidine Assay, k011275 Product Code: LCM Device Classification/Name: Enzyme Immunoassay, Phencyclidine, Unclassified Intended Use:…	Psychemedics Corp.	2002	—

Also cleared against K011275: 1 other device →

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
K212952	Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair	Psychemedics Corporation	2022	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, K212952 (Psychemedics Corporation, 2022) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K011275.

How does its category compare?

All LCM devices

LCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · LCM

1in 2022

2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LCM

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

Recalls per year · LCM

No recall names LCM since 2007.

Adverse event reports per year · LCM

2in 2019

2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code LCM, 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	1	—	0
2010	1	—	0
2011	2	—	2
2012	1	—	1
2013	2	—	0
2014	1	—	0
2015	1	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	1	—	2
2020	0	—	0
2021	1	—	0
2022	1	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Psychemnedics Microplate EIA for Phencyclidine is an enzyme immunoassay (EIA) for the preliminary qualitative detection of phencyclidine in human head and body hair samples using a phencyclidine calibrator at 3 ng /10 mg hair cutoff for the purpose of identifying phencyclidine use. This is an in vitro diagnostic device intended exclusively for Psychemnedics use only and is not intended for sale to anyone. The Psychemnedics EIA Phencyclidine Assay…

Read the full statement (114 words)

The Psychemnedics EIA Phencyclidine Assay provides only a preliminary analytical test result. To obtain a quantitative analytical result or to confirm positive results, a more specific alternate chemical method (e.g. GQ/MS) 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/K111928 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111928: Psychemedics Phencyclidine Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111928

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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