510(k) · Cleared
ClearedSynchron Systems Benzodiazepine (BNZG) Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JXM Enzyme Immunoassay, Benzodiazepine
Cleared on Mar 28, 2005 as substantially equivalent to K023048 (Beckman Coulter, Inc., 2002) after a 91-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Mar 28, 2005
- Review
- 91 days
- Class
- Class II
- Product code
- JXM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944076 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK944076 CX (TM) Benzodiazepine (Benz) Reagent for Sychron CX SysBeckman Instruments, Inc. · 1994
- 1 generation backK023048 Modification to Synchron Systems Benzodiazepine ReagentBeckman Coulter, Inc. · 2002
- This deviceK043556 Synchron Systems Benzodiazepine (BNZG) ReagentBeckman Coulter, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944076 | CX (TM) Benzodiazepine (Benz) Reagent for Sychron CX Sys | Beckman Instruments, Inc. | 1994 | — |
| −1 | K023048 | Modification to Synchron Systems Benzodiazepine Reagent | Beckman Coulter, Inc. | 2002 | — |
| 0 (this device) | K043556 | Synchron Systems Benzodiazepine (BNZG) Reagent | Beckman Coulter, Inc. | 2005 | — |
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 |
|---|---|---|---|
| * | K023048 | Modification to Synchron Systems Benzodiazepine ReagentSummary page 1…Number [ _ _ _ _ _ I SYNCHRON Systems SYNCHRON Systems Beckman Coulter, K023048 BNZG Reagent BENZ Reagent Inc. 5.0 Description: The BNZG assay pro… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 8.0 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K023048.
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?
BNZG reagent, when used in conjunction with SYNCHRON® System(s) and SYNCHRON® Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of Benzodiazepine (BNZG) in human urine at a cutoff value of 200 ng/mL (oxazepam).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043556 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043556: Synchron Systems Benzodiazepine (BNZG) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043556
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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