# K250741: Evidence MultiSTAT DOA Urine MultiPlex

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Jan 23, 2026 after 318 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K014101 (2002). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT, Randox Laboratories Limited (2023) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K250741
Methodology: https://510kreport.com/methodology