510(k) · Cleared
ClearedEvidence MultiSTAT DOA Urine MultiPlex
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 Jan 23, 2026 as substantially equivalent to K220451 (Randox Laboratories Limited, 2023) after a 318-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- Jan 23, 2026
- Review
- 318 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K014101 (2002). 9 ancestors in all, the oldest K973547 (1998). No later device cites it as a predicate yet.
- Root · 5 generations backK014101 Rapidone-Oxy TestAmerican Bio Medica Corp. · 2002
- 4 generations backK040411 Dri Oxycodone AssayMicrogenics Corp. · 2004
- 3 generations backK060351 Medtox OxycodoneMedtox Diagnostics, Inc. · 2006
- 2 generations backK091454 Profile-V Medtoxscan Drugs of Abuse Test SystemMedtox Diagnostics, Inc. · 2009
- 1 generation backK220451 Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited · 2023 · Recalled
- This deviceK250741 Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K014101 | Rapidone-Oxy Test | American Bio Medica Corp. | 2002 | — |
| −4 | K040411 | Dri Oxycodone Assay | Microgenics Corp. | 2004 | — |
| −3 | K060351 | Medtox Oxycodone | Medtox Diagnostics, Inc. | 2006 | — |
| −2 | K091454 | Profile-V Medtoxscan Drugs of Abuse Test System | Medtox Diagnostics, Inc. | 2009 | — |
| −1 | K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT | Randox Laboratories Limited | 2023 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K220451 | Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATSummary page 7…Predicate Devices Proprietary Names and 510(k) Numbers The predicate device for the Evidence MultiSTAT DOA Urine MultiPlex is the Evidence MultiSTAT DOA Urine MultiPlex (k220451). 2 Table 2: Simi… | 2023 |
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.
What does this lineage say?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Mulitplex is intended for use with the Evidence MulitSTAT. The Evidence MultiSTAT is an analyser intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs. The Evidence MultiSTAT DOA Urine Mulitplex detects the following drugs at the following cut offs: Analyte Analyte in Cut off Material Cut Off Methamphetamine S-(+)-Methamphetamine 500ng/ml…
Read the full statement (183 words)
The Evidence MultiSTAT DOA Urine Mulitplex is intended for use with the Evidence MulitSTAT. The Evidence MultiSTAT is an analyser intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.
The Evidence MultiSTAT DOA Urine Mulitplex detects the following drugs at the following cut offs:
Analyte Analyte in Cut off Material Cut Off
Methamphetamine S-(+)-Methamphetamine 500ng/ml
Noroxycodone Norocycodone 100ng/ml
Benzodiazepines 1 Oxazepam 200ng/ml
Methadone (+)-Methadone 300ng/ml
Phenobarbital Phenobarbital 200ng/ml
Tramadol Tramadol 200ng/ml
Phencyclidine Phencyclidine 25ng/ml
Buprenorphine Norbuprenorphine 5ng/ml
6-Acetylmorphine 6-Acetylmorphine 10ng/ml
Fentanyl Fentanyl 1ng/ml
Benzodiazepines 2 Lorazepam 200ng/ml
Opiates Morphine 300ng/ml
Benzoylecgnonine/Cocaine Benzoylecgnonine 150ng/ml
Cannabinoids (THC) (-)-11-nor-9-Caboxy-Δ9-THC 50ng/ml
Amphetamine S-(+)-Amphetamine 500ng/ml
The Evidence MultiSTAT DOA Urine Mulitplex 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) and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K250741: Evidence MultiSTAT DOA Urine MultiPlex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K250741
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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