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Human IgM Kit for use on SPAPlus

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191465

by The Binding Site Group Ltd

Identifiers

510(k) Number
K191465 FDA 510(k)
FDA Product Code
CFN FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5510 FDA 510(k)
Regulation Number
866.5510 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Human IgM Kit is an in vitro diagnostic reagent system designed for the quantitative determination of human IgM in human serum, lithium heparin, or EDTA plasma. It utilizes turbidimetric technology on the SPAPLUS analyzer to measure IgM concentrations, which aids in the diagnosis of abnormal protein metabolism and the body's ability to resist infectious agents.

This device is intended for use in conjunction with other clinical and laboratory findings. It has received FDA 510(k) clearance under K191465. The kit is designed for professional use as a method for nephelometric measurement of immunoglobulins.

Frequently asked questions

What is the Human IgM Kit used for?

This kit is an in vitro diagnostic reagent system designed for the quantitative determination of human IgM concentrations. It is used to aid in the diagnosis of abnormal protein metabolism and to assess the body's ability to resist infectious agents, in conjunction with other clinical and laboratory findings.

Which analyzer is this kit compatible with?

The Human IgM Kit is specifically designed for use on the SPAPlus analyzer. It utilizes turbidimetric technology on this platform to perform nephelometric measurements of immunoglobulins.

What sample types are compatible with this assay?

The assay is validated for use with human serum, lithium heparin plasma, or EDTA plasma samples. These sample types ensure the accurate quantitative determination of IgM when processed according to the system's requirements.

Is this device cleared for clinical use?

Yes, the Human IgM Kit has received FDA 510(k) clearance under K191465. It is intended for professional use as a method for the nephelometric measurement of immunoglobulins.

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: Human IgM Kit for use on SPAPlus (K191465) — FDA 510(k) | Innolitics, Human Igm Liquid Reagent Kit for Use on The Spaplus Analyzer, Human IgM Kit for use on SPAPlus — FDA K191465

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
The Binding Site Group Ltd
FDA Applicant
The Binding Site Group , Ltd.

Sources (1)

  • FDA 510(k) K191465 24 fields · synced Sep 21, 2026