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Alinity c Tricyclic Antidepressants Reagent Kit

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K231020

by Microgenics Corporation

Identifiers

510(k) Number
K231020 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 Alinity c Tricyclic Antidepressants Reagent Kit is an in vitro diagnostic reagent designed for use with ultraviolet (UV) spectrometry. It is intended for the quantitative detection and measurement of tricyclic antidepressant drugs in biological specimens, aiding clinical toxicology assessments.

This reagent kit is supplied as a single-use diagnostic tool for laboratory settings and is intended for use with the Alinity c System. It requires no additional sterilisation beyond manufacturer-provided packaging and is classified as a Class II device under FDA regulations (K231020, LFH). Compliance with IVDD standards is also noted, ensuring adherence to European diagnostic device directives.

Frequently asked questions

What clinical area does this reagent kit support, and how does it function in a lab setting?

This reagent kit supports clinical toxicology, specifically for measuring tricyclic antidepressant drugs in biological specimens. It works with the Alinity c System using ultraviolet (UV) spectrometry to provide quantitative detection, helping clinicians assess drug levels in cases of overdose or therapeutic monitoring. It’s designed exclusively for laboratory use, not point-of-care testing.

Is this reagent kit single-use or reusable, and what does that mean for my lab’s workflow?

The kit is single-use only, meaning each package is intended for one test cycle. This design eliminates cross-contamination risks and ensures consistent, reliable results per the manufacturer’s specifications. Your lab will need to order multiple kits for routine testing, as reuse isn’t supported or recommended.

How is sterility ensured for this reagent kit, and do I need to perform additional sterilization steps?

Sterility is maintained through the manufacturer-provided packaging, which is designed to preserve the kit’s integrity until use. No additional sterilization steps are required beyond opening the sealed package in a controlled lab environment. Always follow the Alinity c System’s operational protocols to maintain sterility during testing.

What regulatory pathways does this device follow, and does it meet international standards like IVDD?

The kit follows the FDA’s 510(k) pathway, classified as a Class II device under K231020 and product code LFH, with a decision of *Substantially Equivalent* in clinical toxicology. It also complies with IVDD (In Vitro Diagnostic Device Directive) standards, ensuring alignment with European regulatory requirements for diagnostic accuracy and safety.

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

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Microgenics Corporation

Sources (2)

  • FDA 510(k) K231020 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026