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FREND Free T4 Test System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K152422

by Nanoentek USA, Inc.

Identifiers

510(k) Number
K152422 FDA 510(k)
FDA Product Code
CEC FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1695 FDA 510(k)
Regulation Number
862.1695 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The FREND Free T4 Test System is a benchtop fluorescence immunoassay device designed for quantifying free thyroxine (FT4) in human serum or lithium heparinized plasma. It operates as a radioimmunoassay system, utilizing fluorescence detection to measure hormone levels with precision.

This system is supplied as a portable cartridge reader paired with single-use microfluidic cartridges, intended for use in clinical chemistry settings. Authorized under FDA 510(k) clearance (K152422) and IVDD compliance, it is classified as a Class II device under regulation 862.1695. The cartridges are disposable, ensuring sterility and single-use per protocol.

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: FREND™ Free T4 Test System (K152422) — FDA 510(k) | Innolitics, FREND™ System Fluorescence Immunoassay Analyzer | NanoEntek, FREND™ Free T4 Test System 510 (k) K152422 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nanoentek USA, Inc.

Sources (2)

  • FDA 510(k) K152422 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026