Evidence MultiSTAT DOA Urine MultiPlex
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221550 FDA 510(k)
- FDA Product Code
- DJG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3650 FDA 510(k)
- Regulation Number
- 862.3650 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Evidence MultiSTAT DOA Urine MultiPlex is an enzyme immunoassay device designed for the simultaneous detection of multiple drugs of abuse in urine samples. It employs immunoassay technology to identify and quantify substances such as opiates, cocaine, amphetamines, and other controlled substances, aiding in clinical toxicology assessments.
This device is intended for use in clinical laboratory settings and is supplied as a reusable analyser with single-use reagents. It has received FDA 510K clearance and IVDR authorisation, adhering to regulatory standards for in vitro diagnostic devices. The system requires minimal sample volume and delivers results within a short timeframe, supporting rapid diagnostic workflows in toxicology testing.
Frequently asked questions
What types of drugs of abuse can the Evidence MultiSTAT DOA Urine MultiPlex detect simultaneously in a single test?
The Evidence MultiSTAT DOA Urine MultiPlex is designed to simultaneously detect multiple drugs of abuse, including opiates, cocaine, amphetamines, and other controlled substances. While the exact list of substances is not fully detailed in the provided data, it is explicitly categorized under clinical toxicology testing for urine samples, indicating its capability to identify a broad range of illicit and prescription drugs commonly screened in toxicology assessments.
Is the Evidence MultiSTAT DOA Urine MultiPlex analyser reusable, and how are the reagents supplied?
Yes, the Evidence MultiSTAT DOA Urine MultiPlex comes with a reusable analyser, which is a key feature for cost efficiency in clinical settings. The single-use reagents are supplied separately, ensuring each test is performed with fresh materials to maintain accuracy and prevent cross-contamination between samples.
What is the typical timeframe for obtaining results with this device, and how much urine sample is required?
The Evidence MultiSTAT DOA Urine MultiPlex is designed to deliver results within a short timeframe, supporting rapid diagnostic workflows in toxicology testing. While the exact duration isn’t specified, the device is noted for requiring minimal sample volume, which is typical for efficient immunoassay devices like this one. This ensures quick turnaround without needing large urine samples.
What regulatory pathways has the Evidence MultiSTAT DOA Urine MultiPlex followed, and what does this mean for clinical use?
The Evidence MultiSTAT DOA Urine MultiPlex has received FDA 510K clearance and IVDR authorisation, meaning it meets regulatory standards for in vitro diagnostic devices in both the United States and the European Union. This ensures compliance with stringent quality, safety, and performance requirements, giving clinicians confidence in its reliability for clinical toxicology assessments in laboratory settings.
How is the device intended to be used in a clinical setting, and what type of environment is it designed for?
The Evidence MultiSTAT DOA Urine MultiPlex is explicitly intended for use in clinical laboratory settings, where toxicology testing is performed. Its design supports rapid, simultaneous detection of multiple drugs of abuse in urine samples, making it suitable for high-throughput environments where efficiency and accuracy are critical. The reusable analyser and single-use reagents are optimized for controlled laboratory workflows.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Evidence Multistat | Fully automated immunoanalyser - Randox Laboratories, Evidence MultiSTAT - Randox Toxicology, The Evidence MultiSTAT - Randox Laboratories, Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT (K220451 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K221550 | Class II | Active |
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Manufacturer
- Manufacturer
- Randox Laboratories Limited
Sources (2)
- FDA 510(k) K221550 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026