DRI TM Tricyclics Serum Tox Assay
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213875 FDA 510(k)
- FDA Product Code
- LFH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3910 FDA 510(k)
- Regulation Number
- 862.3910 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The DRI Tricyclics Serum Toxicity Assay is an in vitro diagnostic device classified as a UV Spectrometry-based assay for detecting tricyclic antidepressant drugs in serum samples. It quantifies serum concentrations of tricyclic antidepressants to aid in clinical toxicology assessments, supporting diagnosis and management of poisoning cases.
This assay is supplied as a single-use reagent kit for laboratory use, requiring validation in accordance with IVDD and FDA 510(k) clearance (K213875). It is intended for use in clinical toxicology settings and must be stored and handled per manufacturer instructions to maintain accuracy. The device is regulated under FDA 510(k) and IVDD standards, ensuring compliance with diagnostic testing requirements for serum toxicity analysis.
Frequently asked questions
What clinical setting is the DRI Tricyclics Serum Tox Assay designed for, and how does it help in patient care?
The DRI Tricyclics Serum Tox Assay is specifically designed for use in clinical toxicology settings, where it aids in diagnosing and managing poisoning cases involving tricyclic antidepressants. By quantifying serum concentrations of these drugs through UV Spectrometry, it provides critical data to support accurate diagnosis and guide appropriate treatment decisions, reducing the risk of misdiagnosis or delayed intervention.
Is the DRI Tricyclics Serum Tox Assay intended for single-use or repeated use, and how should it be stored?
The assay is supplied as a single-use reagent kit, meaning each kit is intended for one test cycle only. To maintain accuracy and reliability, it must be stored and handled strictly according to the manufacturer’s instructions, as outlined in the accompanying documentation. Improper storage could compromise test results.
What regulatory pathways does the DRI Tricyclics Serum Tox Assay follow, and what does this mean for its use in laboratories?
The assay is cleared under FDA 510(k) (K213875) and complies with the In Vitro Diagnostic Device Directive (IVDD). This means it has undergone evaluation by the FDA’s Clinical Toxicology advisory committee and is classified as substantially equivalent to a predicate device, ensuring it meets established safety and performance standards for laboratory use in serum toxicity testing.
What types of tricyclic antidepressants does this assay detect, and how does the UV Spectrometry method work?
The DRI Tricyclics Serum Tox Assay quantifies serum concentrations of tricyclic antidepressant drugs—though the exact compounds detected are not specified, it is designed for this class of medications. The assay uses UV Spectrometry, a precise optical method that measures light absorption at specific wavelengths to determine drug concentration in serum samples, enabling accurate toxicology assessments.
How should laboratories validate this assay before use, and what validation requirements apply?
Since the assay is regulated under IVDD and FDA 510(k) clearance, laboratories must perform validation in accordance with manufacturer instructions to ensure proper performance and reliability. This typically includes verifying accuracy, precision, and reproducibility using control samples, as well as confirming compliance with clinical toxicology testing protocols before routine use.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K213875 | Class II | Active |
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Manufacturer
- Manufacturer
- Microgenics Corporation
Sources (2)
- FDA 510(k) K213875 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026