510(k) · Cleared
ClearedAcon Bar II One Step Barbiturates Test Strip & Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on May 6, 2005 after a 59-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- May 6, 2005
- Review
- 59 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK050593 Acon Bar II One Step Barbiturates Test Strip & DeviceACON Laboratories, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK052197 First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K052197First Sign Drug of Abuse Urine Screening TestW.H.P.M., Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050593 | Acon Bar II One Step Barbiturates Test Strip & Device | ACON Laboratories, Inc. | 2005 | — |
| +1 | K052197 | First Sign Drug of Abuse Urine Screening Test | W.H.P.M., Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
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
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052197 | First Sign Drug of Abuse Urine Screening Test | 2006 | 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?
- Of its descendants, K052197 (W.H.P.M., Inc., 2006) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
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 II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of Barbiturates levels in urine at a designated cutoff concentration of 300 ng/mL (Secobarbital). They are intended for healthcare professionals including professionals at point-of-care sites. This assay provides only a preliminary analytical test result. A more specific alternate…
Read the full statement (109 words)
The ACON BAR II One Step Barbiturates Test Strip and the ACON BAR II One Step Barbiturates Test Device are rapid chromatographic immunoassays for the qualitative detection of Barbiturates levels in urine at a designated cutoff concentration of 300 ng/mL (Secobarbital). They are intended for healthcare professionals including professionals at point-of-care sites.
This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050593: Acon Bar II One Step Barbiturates Test Strip & Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050593
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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