# K013143: Benzodiazepines

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Mar 13, 2002 after 174 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 K910376 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910376: Emit II Benzodiazepine Assay, Syva Co. (1991) Summary page 2.

## Indications for use
The Benzodiazepines assay is used for the qualitative analysis of benzodiazepines in human urine. Measurements obtained by this assay provide only a preliminary analytical test result. A more specific method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry 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/K013143
Methodology: https://510kreport.com/methodology