510(k) · Cleared
Recalled · Class III · 2024Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Randox Laboratories Limited · DJG Enzyme Immunoassay, Opiates
Cleared on Oct 5, 2023 as substantially equivalent to K091454 (Medtox Diagnostics, Inc., 2009) after a 595-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 5, 2023
- Review
- 595 days
- Class
- Class II
- Product code
- DJG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K014101 (2002). 8 ancestors in all, the oldest K973547 (1998). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- 3 generations backK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- 2 generations backK060351 Medtox OxycodoneMedtox Diagnostics, Inc. · 2006
- 1 generation backK091454 Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
- This deviceK220451 Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited · 2023
- Descendant · cites it directly · 0 of its ownK250741 Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026
Most influential descendants
Showing 1 of 1 · See all- K250741Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| −3 | K040411 | Dri Oxycodone Assay | Microgenics Corp. | 2004 | — |
| −2 | K060351 | Medtox Oxycodone | Medtox Diagnostics, Inc. | 2006 | — |
| −1 | K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | Medtox Diagnostics, Inc. | 2009 | — |
| 0 (this device) | K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | 2023 | — |
| +1 | K250741 | Evidence MultiSTAT DOA Urine MultiPlex | Randox Laboratories Limited | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K091454 | Profile-V Medtoxscan Drugs of Abuse Test SystemSummary page 5…4. Predicate Device Proprietary Names and 510(k) Numbers The predicate device for the Evidence MultiSTAT System is the MEDTOXScan® Reader (k091454) and is detailed in table 2. Table 2: Similarities and Differences to Predicate Device Candida… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250741 | Evidence MultiSTAT DOA Urine MultiPlex | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 5, 2024 | Class III | Z-1786-2024 | Device Design | Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K250741 (Randox Laboratories Limited, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K091454.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs. The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs: Analyte Analyte in Cut Off Material Cut-Off Benzodiazepines I Oxazepam 200 ng/mL Methamphetamine…
Read the full statement (155 words)
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cutoffs.
The Evidence MultiSTAT DOA Urine MultiPlex detects the following drugs at the following cut-offs:
Analyte Analyte in Cut Off Material Cut-Off
Benzodiazepines I Oxazepam 200 ng/mL
Methamphetamine S-(+)-Methamphetamine 500 ng/mL
Noroxycodone Noroxycodone 100 ng/mL
Methadone (±)-Methadone 300 ng/mL
The Evidence MultiSTAT DOA Urine MultiPlex 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) and/or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS/MS) are the preferred confirmatory methods. Other chemical confirmation methods are available. Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.
For in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220451 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220451
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026