510(k) · Cleared
ClearedAcon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Sep 17, 2001 as substantially equivalent to K991079 (Princeton BioMeditech Corp., 1999) after a 59-day review. Its family tree reaches back 1 generation to 1999. 92 later devices descend from it.
- Decided
- Sep 17, 2001
- Review
- 59 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991079 (1999). 92 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK991079 Accusign Bzo, Biosign Bzo, Status BzoPrinceton BioMeditech Corp. · 1999
- This deviceK012300 Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo 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 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · 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 | K991079 | Accusign Bzo, Biosign Bzo, Status Bzo | Princeton BioMeditech Corp. | 1999 | — |
| 0 (this device) | K012300 | Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step… | 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 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 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 |
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 JXM? 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 JXM device
- #1 K243498 Alinity c Benzodiazepines Reagent Kitscore 8.8 · 2 generations · no Class I recall
- #2 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K991079 | Accusign Bzo, Biosign Bzo, Status BzoSummary page 2…hat proper volume of specimen has been added and membrane wicking has occurred, Predicéte Device: LifeSign Status DS™ BZO One-Step Benzodiazepines Test 510(k) Number: K991079 Comparison to a Predicatc Device: A comparison of the features of the ACON BZO One Step Benzodiazepines Test Strip and ACON BZ… | 1999 |
What descends from it? (92)
See all 925 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023946 | Acon One Step Multi-Drug Multi-Line Screen Test Card, Acon One Step Multi-Drug… | 2003 | 86 |
| K041685 | Acon Multi-Clin Drug Screen Test Device | 2004 | 1 |
| K121065 | Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of… | 2013 | 0 |
| K052197 | First Sign Drug of Abuse Urine Screening Test | 2006 | 0 |
| K041743 | Acon Tri-Fect Drug Screen Test Device | 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 JXM devicesJXM Enzyme Immunoassay, Benzodiazepine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JXM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JXM
Too few JXM 510(k)s in any year since 2007 to give a median.
Recalls per year · JXM
79in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JXM
6in 2025
MAUDE reports naming product code JXM, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 79 | 5 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 4 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACON BZO One Step Benzodiazepines Test Strip and ACON BZO One Step Benzodiazepines Test Device are rapid chromatographic immunoassays for the qualitative detection of Benzodiazepines in human urine at a cut-off concentration of 300 ng/mL set relative to oxazepam, a major metabolite of benzodiazepines. They are intended for 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/K012300 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012300: Acon Bzo One Step Benzodiazepines Test Strip; Acon Bzo One Step Benzodiazepines Test Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012300
Report an extraction error
Are you the manufacturer?
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