510(k) Report

510(k) · Cleared

Cleared

Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054

K080431510(k) TraditionalCleared Jan 8, 2009324-day reviewClass U

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

Quantrx Biomedical Corporation · LCM Enzyme Immunoassay, Phencyclidine

Cleared on Jan 8, 2009 as substantially equivalent to K011730 (ACON Laboratories, Inc., 2001) after a 324-day review. Its family tree reaches back 2 generations to 1996.

Decided
Jan 8, 2009
Review
324 days
Class
Class U
Product code
LCM
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K961266 (1996). No later device cites it as a predicate yet.

K961266 · Accusign, Biosign PCP · Princeton BioMeditech Corp. · 1996K011730 · Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device · ACON Laboratories, Inc. · 20011995200020052010
K011730 · Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device · ACON Laboratories, Inc. · 2001K961266 · Accusign, Biosign PCP · Princeton BioMeditech Corp. · 19960
  1. Root · 2 generations backK961266 Accusign, Biosign PCPPrinceton BioMeditech Corp. · 1996
  2. 1 generation backK011730 Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step…ACON Laboratories, Inc. · 2001
  3. This deviceK080431 Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models…Quantrx Biomedical Corporation · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K961266Accusign, Biosign PCPPrinceton BioMeditech Corp.1996—
−1K011730Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine…ACON Laboratories, Inc.2001—
0 (this device)K080431Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054Quantrx Biomedical Corporation2009—
FIG. 1 — Lineage of K080431, 1996–2009Source: 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
*K011730Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device
Summary page 2
…30 Comparison to Predicate Device Both the RapidSense TM Drugs of Abuse Phencyclidine (PCP) 25 device and the ACON PCP One Step Phencyclidine Test Device, cleared under K011730 have the indications for use and same cut-off of 25 ng/mL. Both assays are lateral flow competitive immunoassays which provide a…
ACON Laboratories, Inc.2001—

Also cleared against K011730: 5 other devices →

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.

What does this lineage say?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
  • None of the 2 ancestors has a recall.
  • 5 other devices also cite its predicate K011730.

How does its category compare?

All LCM devices

LCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 RapidSense TM Drugs of Abuse Phencyclidine (PCP) 25 Device is a lateral flow competitive immunoassay intended for the qualitative detection for phencyclidine in human urine at a cut-off concentration of 25 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use. This assay provides only'a preliminary result. Clinical consideration and professional judgment should be applied to any…

Read the full statement (128 words)

The RapidSense TM Drugs of Abuse Phencyclidine (PCP) 25 Device is a lateral flow competitive immunoassay intended for the qualitative detection for phencyclidine in human urine at a cut-off concentration of 25 ng/mL. The assay is intended for use in professional laboratories by healthcare professionals. For in vitro diagnostic use.

This assay provides only'a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectroscopy (GC/MS) is the recommended confirmatory method. Tests for PCP cannot distinguish between abused drugs and certain prescribed medications. Certain foods or medications may interfere with tests for, PCP and cause false positive results.

Indications for use as stated in the FDA summary.

Also cleared against K011730

5 other devices cite the same predicate.

  • K121065Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of Abuse Screen DevicePolymed Therapeutics, Inc. · 2013
  • K050594Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine, Methamphetamine & PhencyclidineNano-Ditech Co. · 2005
  • K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc. · 2004
  • K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc. · 2004
  • K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug Multi-Line Screen Test DeviceAcon Laboratories Co. · 2002

More from Quantrx Biomedical Corporation

4 FDA decisions under this applicant name. See the company

  • K080436Rapidsense Drugs of Abuse Cocaine (Coc) 300 Device, Model 900-0052Quantrx Biomedical Corporation · 2009
  • K080455Rapidsense Drugs of Abuse Methamphetamine (Met) 1000 Device, Model 900-0050Quantrx Biomedical Corporation · 2008
  • K070484Quantrx Female Fertility TestQuantrx Biomedical Corporation · 2007

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/K080431 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080431: Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080431

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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