510(k) Report

510(k) · Cleared

Cleared

Psychemedics Ria Phencyclidine Assay

K011275510(k) TraditionalCleared Feb 11, 2002291-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. · LCL Radioimmunoassay, Phencyclidine

Cleared on Feb 11, 2002 after a 291-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Feb 11, 2002
Review
291 days
Class
Class U
Product code
LCL
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2010: 1 descendant cleared2013: 1 descendant cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK011275 Psychemedics Ria Phencyclidine AssayPsychemedics Corp. · 2002
  2. Descendant · cites it directly · 1 of its ownK111928 Psychemedics Phencyclidine EiaPsychemedics Corp. · 2012
  3. Descendant · cites it directly · 1 of its ownK101059 Omega Laboratories Hair Drug Screening Assay for PhencyclidineOmega Laboratories, Inc. · 2010
  4. Descendant · 2 generations on · 0 of its ownK212952 Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine…Psychemedics Corporation · 2022
  5. Descendant · 2 generations on · 0 of its ownK131181 Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc. · 2013

Most influential descendants

Showing 4 of 4 · See all
  • K111928Psychemedics Phencyclidine EiaPsychemedics Corp. · 2012 · cites it directly1descendant
  • K101059Omega Laboratories Hair Drug Screening Assay for PhencyclidineOmega Laboratories, Inc. · 2010 · cites it directly1descendant
  • K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation · 2022 · 2 generations on0descendants
  • K131181Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc. · 2013 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011275Psychemedics Ria Phencyclidine AssayPsychemedics Corp.2002—
+1K111928Psychemedics Phencyclidine EiaPsychemedics Corp.2012—
+1K101059Omega Laboratories Hair Drug Screening Assay for PhencyclidineOmega Laboratories, Inc.2010—
+2K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation2022—
+2K131181Omega Laboratories Hair Drug Screening Assay PhencyclidineOmega Laboratories, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
202210
FIG. 1 — Lineage of K011275, 2002–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K111928Psychemedics Phencyclidine EiaPsychemedics Corp.20121
K101059Omega Laboratories Hair Drug Screening Assay for PhencyclidineOmega Laboratories, Inc.20101

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?

  • Of its descendants, K111928 (Psychemedics Corp., 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LCL devices

LCL Radioimmunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCL

FDA has decided no LCL device since 2007.

Median 510(k) review, days · LCL

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

Recalls per year · LCL

No recall names LCL since 2007.

Adverse event reports per year · LCL

No MAUDE report names LCL since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Psychemedics Corp.

12 FDA decisions under this applicant name. See the company

  • K130811Psychemedics Microplate Eia for AmphetaminePsychemedics Corp. · 2013
  • K123799Psychemedics Microplate Eia for Oxycodone in HairPsychemedics Corp. · 2013
  • K111929Psychemedics Cannabinoids EiaPsychemedics Corp. · 2012
  • K111927Psychemedics Methamphetamine EiaPsychemedics Corp. · 2012
  • K111928Psychemedics Phencyclidine EiaPsychemedics Corp. · 2012

Recent decisions in LCL

The LCL category page

  • K994093AT Work Drug Test, Model 9145-25C; Model 9177-25CPhamatech · 1999
  • K913864PCP Direct Ria Kit (I-125)Immunalysis Corporation · 1991
  • K890882Abuscreen FP for PhencyclidineRoche Diagnostic Systems, Inc. · 1989
  • K882179Emit Hva Phencyclidine AssaySyva Co. · 1988
  • K880011Revised Labeling for Adx PhencyclidineAbbott Laboratories · 1988

https://510kreport.com/device/K011275 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011275: Psychemedics Ria Phencyclidine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011275

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026