510(k) Report

510(k) · Cleared

Cleared

Thermo Scientific Cedia Phencyclidine (PCP) Oft Assay

K101746510(k) TraditionalCleared Apr 8, 2011290-day reviewClass U

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

Microgenics Corp. · LCM Enzyme Immunoassay, Phencyclidine

Cleared on Apr 8, 2011 as substantially equivalent to K000399 (OraSure Technologies, Inc., 2000) after a 290-day review. Its family tree reaches back 1 generation to 2000. 3 later devices descend from it.

Decided
Apr 8, 2011
Review
290 days
Class
Class U
Product code
LCM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K000399 (2000). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2019: 1 descendant cleared2021: 1 descendant clearedK000399 · STC PCP Intercept Micro-Plate Eia, Model 11541 · OraSure Technologies, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K000399 · STC PCP Intercept Micro-Plate Eia, Model 11541 · OraSure Technologies, Inc. · 20000
  1. Root · 1 generation backK000399 STC PCP Intercept Micro-Plate Eia, Model 11541OraSure Technologies, Inc. · 2000
  2. This deviceK101746 Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayMicrogenics Corp. · 2011
  3. Descendant · cites it directly · 2 of its ownK122703 Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control…Biophor Diagnostics, Inc. · 2013
  4. Descendant · 2 generations on · 1 of its ownK181135 Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2019
  5. Descendant · 3 generations on · 0 of its ownK203489 SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021

Most influential descendants

Showing 3 of 3 · See all
  • K122703Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…Biophor Diagnostics, Inc. · 2013 · cites it directly2descendants
  • K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2019 · 2 generations on1descendant
  • K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000399STC PCP Intercept Micro-Plate Eia, Model 11541OraSure Technologies, Inc.2000—
0 (this device)K101746Thermo Scientific Cedia Phencyclidine (PCP) Oft AssayMicrogenics Corp.2011—
+1K122703Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and…Biophor Diagnostics, Inc.2013—
+2K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation2019—
+3K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201910
202110
FIG. 1 — Lineage of K101746, 2000–2021Source: 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), 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. #1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K000399STC PCP Intercept Micro-Plate Eia, Model 11541
Summary page 2
…mparison of Technological Characteristics CEDIA® Phencyclidine (PCP) OFT Assay is substantially equivalent to the previously cleared STO PCP Intercept® MICRO-PLATE SIA, K000399 (At present OTI, OraSure Technologies Inc.) Subject Device Predicate Device Compais…
OraSure Technologies, Inc.2000—

Also cleared against K000399: 2 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K122703Rapidfret Oral Fluid Assay for PCP, PCP Calibrator Set, PCP Control Set and Rapidease…Biophor Diagnostics, Inc.20132

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, K122703 (Biophor Diagnostics, Inc., 2013) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K000399.

How does its category compare?

All LCM devices

LCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LCM

1in 2022

2009: 12010: 12011: 22012: 12013: 22014: 12015: 12017: 12019: 12021: 12022: 1
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

2011: 22012: 12019: 2
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20101—00
20112—02
20121—01
20132—00
20141—00
20151—00
20160—00
20171—00
20180—00
20191—02
20200—00
20211—00
20221—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The CEDIA® Phencyclidine (POP) OFT Assay is intended for use in the qualitative determination of phencyclidine in human oral fluid at a cutoff concentration of 3 nglmL in neat oral fluid. The specimen must be collected exclusively with the Ora-Eze TM Saliva Collection System. The assay is calibrated against POP and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only. The CEDIA Phencyclidine (POP) OFT…

Read the full statement (132 words)

The CEDIA® Phencyclidine (POP) OFT Assay is intended for use in the qualitative determination of phencyclidine in human oral fluid at a cutoff concentration of 3 nglmL in neat oral fluid. The specimen must be collected exclusively with the Ora-Eze TM Saliva Collection System. The assay is calibrated against POP and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Phencyclidine (POP) OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

Indications for use as stated in the FDA summary.

Also cleared against K000399

2 other devices cite the same predicate.

  • K103227Oratect Oral Fluid Drug Screen DevicesBranan Medical Corporation · 2012
  • K093989Oral Fluid PhencyclidineRoche Diagnostics · 2011

More from Microgenics Corp.

107 FDA decisions under this applicant name. See the company

  • K122766Thermo Scientific QMS Everolimus AssayMicrogenics Corp. · 20131 recall
  • K123343Thermo Scientific QMS Tacrolimus Assay and CalibratorsMicrogenics Corp. · 20132 recalls
  • K123271Abbott Phenobarbital AssayMicrogenics Corp. · 2013
  • K110616Thermo Scientific Mas Omni-Immune, Mas Omni Immune ProMicrogenics Corp. · 20113 recalls
  • K101745Thermo Scientific Cedia Amphetamine Oft AssayMicrogenics Corp. · 2011

Recent decisions in LCM

The LCM category page

  • K212952Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in HairPsychemedics Corporation · 2022
  • K203489SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2021
  • K181135Immunalysis SEFRIA PCP Oral Fluid Enzyme ImmunoassayImmunalysis Corporation · 2019
  • K163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc. · 2017
  • K152176Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation · 2015

https://510kreport.com/device/K101746 · printed Nov 4, 2026

Cite this page

510(k) Report. “K101746: Thermo Scientific Cedia Phencyclidine (PCP) Oft Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K101746

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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