# LCM · Enzyme Immunoassay, Phencyclidine

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/LCM

## Overview

- **Product Code:** LCM
- **Device Name:** Enzyme Immunoassay, Phencyclidine
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 88)

Showing 20 most recent of 88 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K212952](/device/K212952.md) | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | Psychemedics Corporation | Apr 18, 2022 | SESE |
| [K203489](/device/K203489.md) | SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | Apr 20, 2021 | SESE |
| [K181135](/device/K181135.md) | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | Immunalysis Corporation | Jan 24, 2019 | SESE |
| [K163220](/device/K163220.md) | Atellica CH Phencyclidine (Pcp) | Siemens Healthcare Diagnostics, Inc. | Apr 6, 2017 | SESE |
| [K152176](/device/K152176.md) | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | Immunalysis Corporation | Sep 4, 2015 | SESE |
| [K142044](/device/K142044.md) | CR3 KEYLESS SPLIT SAMPLE CUP PHENCYCLIDIEN - METHYLENEDIOXYMETHAMPHETAMINE | Guangzhou Wondfo Biotech Co., Ltd. | Aug 25, 2014 | SESE |
| [K131181](/device/K131181.md) | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY  PHENCYCLIDINE | Omega Laboratories, Inc. | Jun 25, 2013 | SESE |
| [K122703](/device/K122703.md) | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND  RAPIDEASE ORAL FLUID COLLECTOR | Biophor Diagnostics, Inc. | Apr 25, 2013 | SESE |
| [K111928](/device/K111928.md) | PSYCHEMEDICS PHENCYCLIDINE EIA | Psychemedics Corp. | May 1, 2012 | SESE |
| [K101746](/device/K101746.md) | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY | Microgenics Corp. | Apr 8, 2011 | SESE |
| [K093989](/device/K093989.md) | ORAL FLUID PHENCYCLIDINE | Roche Diagnostics | Jan 25, 2011 | SESE |
| [K101059](/device/K101059.md) | OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE | Omega Laboratories, Inc. | Jul 12, 2010 | SESE |
| [K080431](/device/K080431.md) | RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 | Quantrx Biomedical Corporation | Jan 8, 2009 | SESE |
| [K062094](/device/K062094.md) | VITROS CHEMISTRY PRODUCTS PCP REAGENT, CALIBRATOR KIT 26, FS CALIBRATOR 1, DAT PERFORMANCE VERIFIERS I, II, III, IV, & V | Ortho-Clinical Diagnostics, Inc. | Nov 22, 2006 | SESE |
| [K060353](/device/K060353.md) | ACRO RAPID PHENCYCLIDINE URINE TEST, CATALOG PCP001000 | Acro Biotech, LLC | May 3, 2006 | SESE |
| [K042726](/device/K042726.md) | QUEST DIAGNOSTICS HAIRCHECK-DT (PCP | Quest Diagnostics, Inc. | Jul 28, 2005 | SESE |
| [K043071](/device/K043071.md) | RANDOX PHENCYCLIDINE ASSAY | Randox Laboratories, Ltd. | Jan 27, 2005 | SESE |
| [K043305](/device/K043305.md) | ONLINE DAT PHENCYCLIDINE PLUS | Roche Diagnostics Corp. | Jan 10, 2005 | SESE |
| [K041578](/device/K041578.md) | QUICKSCREEN, MODELS 9177X AND 9178X | Phamatech | Sep 10, 2004 | SESE |
| [K023109](/device/K023109.md) | AMEDICA DRUG SCREEN PHENCYCLIDINE TEST | Amedica Biotech, Inc. | Dec 16, 2002 | SESE |

## Top Applicants

- Syva Co. — 10 clearances
- Abbott Laboratories — 5 clearances
- Phamatech — 4 clearances
- Roche Diagnostic Systems, Inc. — 4 clearances
- Roche Diagnostics Corp. — 4 clearances

---

**Source:** [https://fda.innolitics.com/productcode/LCM](https://fda.innolitics.com/productcode/LCM)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com