# K080057: Imdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep Control

- Pathway: 510(k) (Traditional)
- Applicant: Novx Systems, Inc.
- Decided: Oct 31, 2008 after 296 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The iMDxTM System is an in vitro diagnostic device consisting of iMDxTM Analyzer and iMDxPrepTM Assays. The system is an expandable, closed system. All assays are designed for use with automated iMDxTM Analyzer. The system -has been designed to be used by practitioners in drug rehabilitation clinics, physician offices, and clinical laboratories. The Amphetamines (Amphetamines and Methamphetamine), Oxycodone (Oxycodone), Phencyclidine (Phencyclidine) and Cannabinoids (A9 -THC-COOH) assays are enzyme immunoassays with cutoffs of 1000 ng/mL, 100ng/mL, 25 ng/mL and 50 ng/mL, respectively. These assays are intended for use in the qualitative and semi-quantitative analysis of Amphetamine, Oxycodone, Phencyclidine and Cannabinoids in human urine. Semi-quantitative analysis is for the estimation of dilution for confirmation testing and to establish quality control procedures and assess quality control performance in general. Periodic calibration and use of control are required to maintain testing accuracy and assay performance. All assays provide only a preliminary result. Clinical consideration and professional judgment must be applied to a drug test result, particularly in evaluating a preliminary positive result. In order to obtain a confirned analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectroscopy (GC/MS) analysis is performed. FOR USE BY TRAINED PERSONNEL ONLY. Only operators trained in the use of the iMDxTM System by NOVX personnel should perform these procedures.

Source page: https://510kreport.com/device/K080057
Methodology: https://510kreport.com/methodology