510(k) · Cleared
ClearedImdx Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novx Systems, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Jun 1, 2007 after a 170-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 1, 2007
- Review
- 170 days
- Class
- Class II
- Product code
- DJG
- 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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 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 DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The iMDXTM System is an in vitro diagnostic device consisting of iMDxTM Analyzer and iMDxPrep TM Assays. The system is an expandable, closed system. All assays are designed for use with automated iMDx T Analyzer. The system has been designed to be used by practitioners in drug rehabilitation clinics, physician offices, and clinical laboratories. The Opiates (Morphine), Benzodiazepine (Oxazepam) and Cocaine Metabolite (Benzoylecgonine) Assays are an…
Read the full statement (248 words)
The iMDXTM System is an in vitro diagnostic device consisting of iMDxTM Analyzer and iMDxPrep TM Assays. The system is an expandable, closed system. All assays are designed for use with automated iMDx T Analyzer. The system has been designed to be used by practitioners in drug rehabilitation clinics, physician offices, and clinical laboratories.
The Opiates (Morphine), Benzodiazepine (Oxazepam) and Cocaine Metabolite (Benzoylecgonine) Assays are an enzyme immunoassay with a 300ng/mL cutoff. These assays are intended for use in the qualitative and semi-quantitative analysis of Opiates, Benzodiazepine and Cocaine Metabolite in human urine. The Methadone Metabolite (EDDP) Assay is an enzyme immunoassay with a lOOng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analysis of Methadone Metabolite in human urine. For point of care use semi-quantitative analysis is only for estimation of dilution for confirmation testing.
The Ethyl Alcohol Assay is an enzymatic assay intended for use in quantitative analysis of ethyl alcohol in human urine. Measurements contained are used in the diagnosis and treatment of alcohol intoxication and poisoning.
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 confirmed 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 iMDx Tm System by NOVX personnel should perform these procedures.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K063699 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063699: Imdx Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063699
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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