510(k) · Cleared

Cleared

Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device

K012824510(k) TraditionalCleared Nov 9, 200178-day reviewClass II21 CFR 862.3150

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

ACON Laboratories, Inc. · DIS Enzyme Immunoassay, Barbiturate

Cleared on Nov 9, 2001 as substantially equivalent to K002337 (Branan Medical Corporation, 2000) after a 78-day review. Its family tree reaches back 1 generation to 2000. 90 later devices descend from it.

Decided: Nov 9, 2001
Review: 78 days
Class: Class II
Product code: DIS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002337 (2000). 90 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK002337 Branan Medical Corporation Monitect Barbiturates Drug Screen TestBranan Medical Corporation · 2000
This deviceK012824 Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step…ACON Laboratories, Inc. · 2001
Descendant · cites it directly · 86 of its ownK023946 Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step…ACON Laboratories, Inc. · 2003
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
Descendant · 3 generations on · 80 of its ownK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
Descendant · 4 generations on · 55 of its ownK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
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 90 descendants. See all descendants

Descendants cleared per year

2003high 9 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 90 · See all

K023946Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…ACON Laboratories, Inc. · 2003 · cites it directly86descendants
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

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002337	Branan Medical Corporation Monitect Barbiturates Drug Screen Test	Branan Medical Corporation	2000	—
0 (this device)	K012824	Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test…	ACON Laboratories, Inc.	2001	—
+1	K023946	Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…	ACON Laboratories, Inc.	2003	—
+2	K031759	Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum…	ACON Laboratories, Inc.	2003	1
+3	K061718	Innovacon Spectrum II Test Card	Innovacon, Inc.	2006	6
+4	K122809	Advin Multi-Drug Screen Test Cassette, Dip Card and Cup	Advin Biotech	2013	—
+5	K140748	One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard	Co-Innovation Biotech Co., Ltd.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	2	0
2004	3	0
2005	1	0
2006	2	0
2009	1	0
2011	1	0
2012	1	0
2013	3	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 K012824, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K002337	Branan Medical Corporation Monitect Barbiturates Drug Screen Test Summary page 2 …g has occurred. Predicate Device: MCC Instant Screen Card BAR Test Distributed by Medical & Clinical Consortium (MCC), City of Industry, CA 91746-2048 510(k) Number: K002337 Comparison to a Predicate Device: A comparison of the features of the ACON BAR One Step Barbiturates Test Strip and ACON BAR On…	Branan Medical Corporation	2000	—

What descends from it? (90)

See all 90

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

Number	Device	Applicant	Decided	Descendants
K023946	Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug…	ACON Laboratories, Inc.	2003	86
K041685	Acon Multi-Clin Drug Screen Test Device	ACON Laboratories, Inc.	2004	1
K041743	Acon Tri-Fect Drug Screen Test Device	ACON Laboratories, Inc.	2004	0

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, K023946 (ACON Laboratories, Inc., 2003) has gone furthest, with 86 descendants of its own.

How does its category compare?

All DIS devices

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

FDA decisions per year · DIS

1in 2016

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIS

29in 2015

2007high 331 (2007) · low 29 (2015)2026

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

Recalls per year · DIS

1in 2016

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DIS

1in 2018

2007high 1 (2007) · low 0 (2009)2025

MAUDE reports naming product code DIS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	3	331	0	1
2008	0	—	0	1
2009	0	—	0	0
2010	0	—	0	0
2011	2	—	1	0
2012	0	—	1	0
2013	0	—	0	0
2014	2	—	0	0
2015	3	29	0	0
2016	1	—	1	0
2017	0	—	0	0
2018	0	—	0	1
2019	0	—	0	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	0	—

What is it indicated for?

The ACON BAR One Step Barbiturates Test Strip and ACON BAR One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of barbiturates in human urine at a level relative to the secobarbital cut-off concentration of 300 ng/mL. They are intended for use by healthcare professionals including professionals at 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.

https://510kreport.com/device/K012824 · printed Nov 4, 2026

Cite this page

510(k) Report. “K012824: Acon Bar One Step Barbiturates Test Strip, Acon Bar One Step Barbiturates Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012824

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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