510(k) · Cleared
ClearedSynchron Systems Bebzodiazapine (Ebnz) 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 Jun 13, 2005 as substantially equivalent to K023048 (Beckman Coulter, Inc., 2002) after a 25-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Jun 13, 2005
- Review
- 25 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 deviceK051307 Synchron Systems Bebzodiazapine (Ebnz) 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) | K051307 | Synchron Systems Bebzodiazapine (Ebnz) 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…zepine Reagent claims substantial equivalence to the SYNCHRON Systems Benzodiazepine Reagent currently in commercial distribution. (FDA 510(k) Number K023048) 5.0 Device Description The SYNCHRON Systems Benzodiazepine (BENZ) reagent is designed for optimal perfo… | 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?
Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON © Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL, (oxazepam) on SYNCHRON Systems. The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines in urine. This test provides only a preliminary analytical result; a positive result…
Read the full statement (119 words)
Benzodiazepine (BENZ) Reagent, in conjunction with SYNCHRON © Systems Drugs of Abuse Testing (DAT) Urine Calibrators, is intended for the qualitative determination of benzodiazepines in human urine at a cutoff value of 200 ng/mL, (oxazepam) on SYNCHRON Systems.
The Benzodiazepine assay provides a rapid screening procedure for determining the presence of benzodiazepines in urine. This test provides only a preliminary analytical result; a positive result by this assay should be confirmed by another generally accepted non-immunological method, such as thin layer chromatography (TLC), gas chromatography (GC), or gas chromatography/mass spectrometry (GC/MS). GC/MS is the preferred confirmatory method.
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/K051307 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051307: Synchron Systems Bebzodiazapine (Ebnz) Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051307
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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