# K220451: Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Oct 5, 2023 after 595 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K014101 (2002). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091454: Profile-V Medtoxscan Drugs of Abuse Test System, Medtox Diagnostics, Inc. (2009) Summary page 5.

## Most influential descendants
- K250741: Evidence MultiSTAT DOA Urine MultiPlex (2026), 0 descendants of its own

## Recalls of this device
- Apr 5, 2024 · Class III · Z-1786-2024: 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 du

## Indications for use
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.

Source page: https://510kreport.com/device/K220451
Methodology: https://510kreport.com/methodology