# K173963: DRI Benzodiazepine Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corporation
- Decided: Feb 21, 2018 after 55 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 K930529 (1993). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930529: Benzodiazepine Enzyme Immunoassay, Diagnostic Reagents, Inc. (1993) Summary page 4.

## Most influential descendants
- K182719: Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro (2019), 1 descendant of its own
- K243498: Alinity c Benzodiazepines Reagent Kit (2024), 0 descendants of its own
- K200363: Quidel Triage® TOX Drug Screen, 94600 (2020), 0 descendants of its own

## Indications for use
The DRI Benzodiazepine Assay is a homogeneous enzyme immunoassay intended for the qualitative and/or semi-quantitative determination of the presence of benzodiazepines and their metabolites in human urine at a cutoff concentration of 200 ng/mL. The assay is intended to be used in laboratories and provides a simple and rapid analytical screening procedure to detect benzodiazepines in human urine. The assay is designed for use with a number of clinical chemistry analyzers. This assay is calibrated against Oxazepam. This product is intended to be used by trained professionals only. The semi-quantitative mode is for the purpose of enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as Liquid Chromatography/tandem mass spectrometry (LC-MS/MS) or permitting laboratories to establish quality control procedures. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) or Liquid chromatography/tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse test result, particularly when preliminary results are used. For In Vitro Diagnostic Use Only.

Source page: https://510kreport.com/device/K173963
Methodology: https://510kreport.com/methodology