510(k) · Cleared

Cleared

Accusign Met/Biosign Met

K961249510(k) TraditionalCleared Apr 25, 199624-day reviewClass II21 CFR 862.3610

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

Princeton BioMeditech Corp. · LAF Gas Chromatography, Methamphetamine

Cleared on Apr 25, 1996 after a 24-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 92 later devices descend from it.

Decided: Apr 25, 1996
Review: 24 days
Class: Class II
Product code: LAF
Recalls: None
Predicates: 0

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

This deviceK961249 Accusign Met/Biosign MetPrinceton BioMeditech Corp. · 1996
Descendant · cites it directly · 91 of its ownK011672 Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step…ACON Laboratories, Inc. · 2001
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
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
Descendant · 4 generations on · 80 of its ownK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
Descendant · 5 generations on · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013

Showing 5 of 92 descendants. See all descendants

Descendants cleared per year

2001high 9 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 92 · See all

K011672Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test…ACON Laboratories, Inc. · 2001 · cites it directly91descendants
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

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K961249	Accusign Met/Biosign Met	Princeton BioMeditech Corp.	1996	—
+1	K011672	Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step…	ACON Laboratories, Inc.	2001	—
+2	K020313	Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug…	Acon Laboratories Co.	2002	—
+3	K031759	Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum…	ACON Laboratories, Inc.	2003	1
+4	K061718	Innovacon Spectrum II Test Card	Innovacon, Inc.	2006	6
+5	K122809	Advin Multi-Drug Screen Test Cassette, Dip Card and Cup	Advin Biotech	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	1	0
2004	1	0
2005	4	0
2006	2	0
2008	1	0
2009	1	0
2011	1	0
2012	1	0
2013	2	0
2014	4	0
2015	9	0
2016	9	0
2017	2	0
2018	9	0
2019	6	0
2020	4	0
2021	3	0
2022	3	0
2023	7	0
2024	9	0
2025	7	0
2026	4	0

FIG. 1 — Lineage of K961249, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LAF? 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 LAF device

#1 K203647 SEFRIA Methamphetamine Oral Fluid Enzyme…score 3.8 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 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? (92)

See all 92

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

Number	Device	Applicant	Decided	Descendants
K011672	Acon Mamp One Step Methamphetamine Test Strip, Acon Mamp One Step Methamphetamine Test…	ACON Laboratories, Inc.	2001	91

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, K011672 (ACON Laboratories, Inc., 2001) has gone furthest, with 91 descendants of its own.

How does its category compare?

All LAF devices

LAF Gas Chromatography, Methamphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LAF

2in 2021

2007high 4 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LAF

43in 2015

2007high 345 (2011) · low 43 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LAF

No recall names LAF since 2007.

Adverse event reports per year · LAF

No MAUDE report names LAF since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	2	—	0
2009	0	—	0
2010	0	—	0
2011	4	345	0
2012	2	—	0
2013	0	—	0
2014	2	—	0
2015	3	43	0
2016	1	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	1	—	0
2021	2	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

https://510kreport.com/device/K961249 · printed Nov 5, 2026

Cite this page

510(k) Report. “K961249: Accusign Met/Biosign Met.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961249

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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