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Accubind Neo-Tsh Microwell Elisa, Model 3425-300

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063437

by Monobind, Inc.

Identifiers

510(k) Number
K063437 FDA 510(k)
FDA Product Code
JLW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1690 FDA 510(k)
Regulation Number
862.1690 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Accubind Neo-Tsh Microwell Elisa, Model 3425-300 is an in vitro diagnostic test system for the quantitative determination of thyroid stimulating hormone (TSH) in human whole blood dried on Whatman 903 filter paper. It is a radioimmunoassay device classified under device class 2 and product code JLW, with regulation number 862.1690 and medical specialty description in Clinical Chemistry.

The device is supplied as a kit and has received FDA 510(k) clearance under K063437, with a traditional clearance type and substantially equivalent decision. It is manufactured by Monobind, Inc. and intended for use in clinical laboratory settings to aid in the assessment of thyroid function, supporting the diagnosis and monitoring of thyroid disorders such as hypothyroidism and hyperthyroidism.

Frequently asked questions

What is the Accubind Neo-Tsh Microwell Elisa, Model 3425-300 used for?

It is used for the quantitative determination of thyroid stimulating hormone (TSH) in human whole blood dried on Whatman 903 filter paper, aiding in the assessment of thyroid function to support diagnosis and monitoring of thyroid disorders such as hypothyroidism and hyperthyroidism.

How is the Accubind Neo-Tsh Microwell Elisa, Model 3425-300 supplied?

The device is supplied as a kit, containing all necessary components for performing the TSH assay on dried blood spot samples collected on Whatman 903 filter paper.

Is the Accubind Neo-Tsh Microwell Elisa, Model 3425-300 intended for single-use or reuse?

As an in vitro diagnostic test system supplied as a kit for use with dried blood spot samples, it is intended for single-use per test run, with reagents and wells designed for one-time application to prevent cross-contamination and ensure accurate results.

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: Accubind Neo-tsh Microwell Elisa, Model 3425-300, Accubind Neo-tsh Microwell Elisa, Model 3425-300, TSH AccuBind ELISA Kit - 96 wells - monobind.com, NTSH AccuBind ELISA Kit | 3425-300 | monobind, 3425-300.IFU.Neo-TSH.AccuBind.ELISA - monobind-preview.vintencloud.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monobind, Inc.

Sources (1)

  • FDA 510(k) K063437 24 fields · synced Sep 21, 2026