# K023048: Modification to Synchron Systems Benzodiazepine Reagent

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Nov 7, 2002 after 55 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: 1 generation back to K944076 (1994). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944076: CX (TM) Benzodiazepine (Benz) Reagent for Sychron CX Sys, Beckman Instruments, Inc. (1994) Summary page 1.

## Most influential descendants
- K051307: Synchron Systems Bebzodiazapine (Ebnz) Reagent (2005), 0 descendants of its own
- K043556: Synchron Systems Benzodiazepine (BNZG) Reagent (2005), 0 descendants of its own

## 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, 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/K023048
Methodology: https://510kreport.com/methodology