510(k) · Cleared
ClearedImdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novx Systems, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Oct 31, 2008 after a 296-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 31, 2008
- Review
- 296 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DKZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (214 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K080057 · printed Nov 5, 2026
Cite this page
510(k) Report. “K080057: Imdx Analyzer, Imdxprep Reagent Plate, Imdxprep Calibration Plate, Imdxprep Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K080057
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026