510(k) Report

510(k) · Cleared

Cleared

Livesure Phenecycline (PCP) Screen Tests

K012107510(k) TraditionalCleared Jul 20, 200115-day reviewClass U

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

Pan Probe Biotech, Inc. · LCM Enzyme Immunoassay, Phencyclidine

Cleared on Jul 20, 2001 after a 15-day review. The FDA summary names its predicate without a number.

Decided
Jul 20, 2001
Review
15 days
Class
Class U
Product code
LCM
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K012107Source: FDA 510(k) database · 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*—EMIT® II Assay
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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.

How does its category compare?

All LCM devices

LCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for detection of Phencyclidine, analogs and metabolites (collectively: PCP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 25 ng PCP/mi. These IVD tests are…

Read the full statement (154 words)

The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary assays for detection of Phencyclidine, analogs and metabolites (collectively: PCP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental Health Services Administration) cut-off level of 25 ng PCP/mi. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative results, nor for over the counter sales. Pan Probe LiveSure™ PCP Screen Tests for PCP provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Pan Probe Biotech, Inc.

10 FDA decisions under this applicant name. See the company

  • K020968Livesure HCG Urinary Pregnancy Test Strip and Test CardPan Probe Biotech, Inc. · 2002
  • K013796Livesure Methadone Screen TestsPan Probe Biotech, Inc. · 2001
  • K012131Livesure Benzodiazepines Screen TestsPan Probe Biotech, Inc. · 2001
  • K012133Livesure Barbiturates Screen TestPan Probe Biotech, Inc. · 2001
  • K011610Livesure Methamphetamine Screen TestsPan Probe Biotech, Inc. · 2001

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/K012107 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012107: Livesure Phenecycline (PCP) Screen Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012107

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Page last updated Nov 3, 2026