# K983702: Modification to Abuscreen Online for Benzoidiazepines

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Feb 11, 1999 after 113 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 K914509 (1991). 1 ancestor in all.
2 later devices descend 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)
- K914509: Abuscreen (R) Online (TM) for Benzodiazepines, Roche Diagnostic Systems, Inc. (1991) Summary page 2.

## Most influential descendants
- K043327: Online Dat Benzodiazepines Plus (2005), 1 descendant of its own
- K221765: ONLINE DAT Benzodiazepines II (2022), 0 descendants of its own

## Indications for use
Abuscreen ONLINE Benzodiazepines is an in vifra diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on the Hitachi 917 analyzer at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of benzodiazepine use or abuse.

Source page: https://510kreport.com/device/K983702
Methodology: https://510kreport.com/methodology