# K032365: Benzodiazepine Enzyme Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Sep 5, 2003 after 36 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 K993985 (2000). 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)
- K993985: Syva Emit II Plus Benzodiazepine Assay, Models 9F029UL/9F129UL, Syva Co. (2000) Summary page 1.

## Most influential descendants
- K033885: BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) (2004), 0 descendants of its own

## Indications for use
The Benzodiazepine Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of benzodiazepines in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Benzodiazepine Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when the preliminary positive results are used. The Benzodiazepine Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Benzodiazepine enzyme immunoassay to detect benzodiazepines in human urine. The Benzodiazepine Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Benzodiazepine enzyme immunoassay to detect benzodiazepines in human urine.

Source page: https://510kreport.com/device/K032365
Methodology: https://510kreport.com/methodology