510(k) Report

510(k) · Cleared

Cleared

Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device

K011730510(k) TraditionalCleared Aug 9, 200165-day reviewClass U

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

ACON Laboratories, Inc. · LCM Enzyme Immunoassay, Phencyclidine

Cleared on Aug 9, 2001 as substantially equivalent to K961266 (Princeton BioMeditech Corp., 1996) after a 65-day review. Its family tree reaches back 1 generation to 1996. 95 later devices descend from it.

Decided
Aug 9, 2001
Review
65 days
Class
Class U
Product code
LCM
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K961266 (1996). 95 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 3 descendants cleared2005: 4 descendants cleared2002: 1 descendant cleared2009: 2 descendants cleared2013: 4 descendants cleared2006: 2 descendants cleared2003: 1 descendant cleared2014: 4 descendants cleared2016: 9 descendants cleared2015: 9 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2018: 9 descendants cleared2020: 4 descendants cleared2023: 7 descendants cleared2019: 6 descendants cleared2017: 2 descendants cleared2025: 7 descendants cleared2021: 3 descendants cleared2024: 9 descendants cleared2022: 3 descendants cleared2026: 4 descendants clearedK961266 · Accusign, Biosign PCP · Princeton BioMeditech Corp. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants4 generations forward: 7 descendants5 generations forward: 23 descendants6 generations forward: 20 descendants7 generations forward: 16 descendants8 generations forward: 9 descendants9 generations forward: 5 descendants K961266 · Accusign, Biosign PCP · Princeton BioMeditech Corp. · 19960+5
  1. Root · 1 generation backK961266 Accusign, Biosign PCPPrinceton BioMeditech Corp. · 1996
  2. This deviceK011730 Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step…ACON Laboratories, Inc. · 2001
  3. Descendant · cites it directly · 88 of its ownK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
  4. Descendant · 2 generations on · 83 of its ownK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
  5. Descendant · 3 generations on · 80 of its ownK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
  6. Descendant · 4 generations on · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
  7. Descendant · 5 generations on · 16 of its ownK140748 One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test…Co-Innovation Biotech Co., Ltd. · 2014

Showing 5 of 95 descendants. See all descendants

Descendants cleared per year

2002: 12003: 12004: 32005: 42006: 22009: 22011: 12012: 12013: 42014: 42015: 92016: 92017: 22018: 92019: 62020: 42021: 32022: 32023: 72024: 92025: 72026: 4
2002high 9 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 95 · See all
  • K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Acon Laboratories Co. · 2002 · cites it directly88descendants
  • K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…ACON Laboratories, Inc. · 2003 · 2 generations on83descendants
  • K061718Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · 3 generations on80descendants
  • K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013 · 4 generations on55descendants
  • K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd. · 2014 · 5 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K961266Accusign, Biosign PCPPrinceton BioMeditech Corp.1996—
0 (this device)K011730Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine…ACON Laboratories, Inc.2001—
+1K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Acon Laboratories Co.2002—
+2K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum…ACON Laboratories, Inc.20031
+3K061718Innovacon Spectrum II Test CardInnovacon, Inc.20066
+4K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech2013—
+5K140748One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test DipcardCo-Innovation Biotech Co., Ltd.2014—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200310
200430
200540
200620
200920
201110
201210
201340
201440
201590
201690
201720
201890
201960
202040
202130
202230
202370
202490
202570
202640
FIG. 1 — Lineage of K011730, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K961266Accusign, Biosign PCP
Summary page 2
…will always appear at the control region if the test has been performed properly. Predicate Device: LifeSign Status DS™ PCP One-Step Phencyclidine Test 510(k) Number: K961266 Distributor: LifeSign, LLC 71 Veronica Avenue Somerset, New Jersey 08873 Comparison to a Predicate Device: A comparison of t…
Princeton BioMeditech Corp.1996—

What descends from it? (95)

See all 95

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

NumberDeviceApplicantDecidedDescendants
K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Acon Laboratories Co.200288
K041685Acon Multi-Clin Drug Screen Test DeviceACON Laboratories, Inc.20041
K121065Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of…Polymed Therapeutics, Inc.20130
K080431Rapidsense Drugs of Abuse Phencyclidine (PCP) 25 Device with Models 900-0054Quantrx Biomedical Corporation20090
K050594Nano-Check Dat 5 Multi Drug Screening Test for Cannabinoids, Opiates, Cocaine…Nano-Ditech Co.20050
K041743Acon Tri-Fect Drug Screen Test DeviceACON Laboratories, Inc.20040

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, K020313 (Acon Laboratories Co., 2002) has gone furthest, with 88 descendants of its own.

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 ACON PCP One Step Phencyclidine Test Strip and ACON PCP One Step Phencyclidine Test Device are rapid chromatographic immunoassays for the qualitative detection of phencyclidine in human urine at a cut-off concentration of 25 ng/mL. They are intended for healthcare professionals including point of care sites.

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

More from ACON Laboratories, Inc.

86 FDA decisions under this applicant name. See the company

  • K261212Flowflex Plus RSV + Flu A/B + COVID Rapid TestACON Laboratories, Inc. · 2026
  • K251697Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test StripACON Laboratories, Inc. · 2025
  • K251749Flowflex Plus RSV + Flu A/B + COVID Home TestACON Laboratories, Inc. · 2025
  • K250085On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone…ACON Laboratories, Inc. · 2025
  • K250377Flowflex Plus COVID-19 + Flu A/B Home TestACON Laboratories, Inc. · 2025

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/K011730 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011730: Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011730

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