# K962734: Cedia Dau Benzodiazepine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Dec 10, 1996 after 148 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 K954626 (1995). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954626: Cedia Dau Benzodiazepine Assay (Modification), Microgenics Corp. (1995) Summary page 1.

## Most influential descendants
- K190968: CEDIA Benzodiazepine Assay (2019), 0 descendants of its own

## Indications for use
The Modified CEDIA DAU Benzodiazepine Assay is a homogeneous enzyme immunoassay for the qualitative and semi-quantitative assay of benzodiazepines in human urine. Measurements are used as an aid in the diagnosis and treatment of benzodiazepine use or overdose.

Source page: https://510kreport.com/device/K962734
Methodology: https://510kreport.com/methodology