# K221550: Evidence MultiSTAT DOA Urine MultiPlex

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Oct 5, 2023 after 492 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: 4 generations back to K014101 (2002). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 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 4.

## 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 Phenobarbital Phenobarbital 200 ng/ml Tramadol Tramadol 200 ng/ml Phencyclidine Phencyclidine 25 ng/ml Buprenorphine Norbuprenorphine 5 ng/ml 6-Acetylmorphine 6-Acetylmorphine 10 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/K221550
Methodology: https://510kreport.com/methodology