510(k) Report

510(k) · Cleared

Cleared

Accusign, Biosign PCP

K961266510(k) TraditionalCleared May 31, 199659-day reviewClass U

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

Princeton BioMeditech Corp. · LCM Enzyme Immunoassay, Phencyclidine

Cleared on May 31, 1996 after a 59-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 96 later devices descend from it.

Decided
May 31, 1996
Review
59 days
Class
Class U
Product code
LCM
Recalls
None
Predicates
0

96 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared2004: 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 cleared1995200020052010201520202025
  1. This deviceK961266 Accusign, Biosign PCPPrinceton BioMeditech Corp. · 1996
  2. Descendant · cites it directly · 95 of its ownK011730 Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step…ACON Laboratories, Inc. · 2001
  3. Descendant · 2 generations on · 88 of its ownK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
  4. Descendant · 3 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 · 4 generations on · 80 of its ownK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
  6. Descendant · 5 generations on · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013

Showing 5 of 96 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12004: 32005: 42006: 22009: 22011: 12012: 12013: 42014: 42015: 92016: 92017: 22018: 92019: 62020: 42021: 32022: 32023: 72024: 92025: 72026: 4
2001high 9 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 96 · See all
  • K011730Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test DeviceACON Laboratories, Inc. · 2001 · cites it directly95descendants
  • K020313Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…Acon Laboratories Co. · 2002 · 2 generations on88descendants
  • K031759Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum Multi-Drug…ACON Laboratories, Inc. · 2003 · 3 generations on83descendants
  • K061718Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · 4 generations on80descendants
  • K122809Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013 · 5 generations on55descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
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 K961266, 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (96)

See all 96

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

NumberDeviceApplicantDecidedDescendants
K011730Acon PCP One-Step Phencyclidine Test Strip, Acon PCP One-Step Phencyclidine Test DeviceACON Laboratories, Inc.200195

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?

  • Of its descendants, K011730 (ACON Laboratories, Inc., 2001) has gone furthest, with 95 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—

More from Princeton BioMeditech Corp.

72 FDA decisions under this applicant name. See the company

  • K251538Status™ COVID-19/Flu A&BPrinceton BioMeditech Corp. · 2025
  • K182157BioSign Flu A+BPrinceton BioMeditech Corp. · 2018
  • K130650Status DS OxyPrinceton BioMeditech Corp. · 2014
  • K133474Biosign Flu a + B, Status Flu a & BPrinceton BioMeditech Corp. · 2013
  • K132465Biosign Flu a + B, Status Flu a & BPrinceton BioMeditech Corp. · 2013

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/K961266 · printed Nov 6, 2026

Cite this page

510(k) Report. “K961266: Accusign, Biosign PCP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961266

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026