# K043327: Online Dat Benzodiazepines Plus

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Feb 7, 2005 after 67 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 K914509 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K983702: Modification to Abuscreen Online for Benzoidiazepines, Roche Diagnostic Systems, Inc. (1999) Summary page 1.

## Most influential descendants
- K221765: ONLINE DAT Benzodiazepines II (2022), 0 descendants of its own

## Indications for use
Benzodiazepines Plus is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers at cutoff concentrations of 100 ng/ml, 200 ng/ml and 300 ng/ml. Semi-quantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program.

Source page: https://510kreport.com/device/K043327
Methodology: https://510kreport.com/methodology