# K051307: Synchron Systems Bebzodiazapine (Ebnz) Reagent

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Jun 13, 2005 after 25 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K944076 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023048: Modification to Synchron Systems Benzodiazepine Reagent, Beckman Coulter, Inc. (2002) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K051307
Methodology: https://510kreport.com/methodology