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Optilite IgA CSF Kit

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K183151

by The Binding Site Group Ltd

Identifiers

510(k) Number
K183151 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 Optilite IgA CSF Kit is a nephelometric in vitro diagnostic reagent system designed for the quantitative measurement of Immunoglobulin A (IgA) in cerebrospinal fluid (CSF) samples. It employs immunoturbidimetric technology, utilizing goat anti-IgA antibodies to form insoluble complexes with IgA in the sample, enabling precise detection and quantification of IgA concentrations.

This kit is intended for use with the Optilite analyser and is supplied as a single-use diagnostic reagent. It is classified under the In Vitro Diagnostic Regulation (IVDR) and holds FDA 510(k) clearance (K183151) as substantially equivalent. The device is not MRI-safe, and storage conditions are not specified in the provided data. It is regulated under the classification name 866.5510, corresponding to immunology-related diagnostic assays.

Frequently asked questions

What is the Optilite IgA CSF Kit used for in clinical practice?

The Optilite IgA CSF Kit is designed for the quantitative measurement of Immunoglobulin A (IgA) in cerebrospinal fluid (CSF) samples. It uses immunoturbidimetric technology to detect IgA levels, which can help assess conditions related to immune responses in the central nervous system, such as certain neurological or inflammatory disorders.

Is the Optilite IgA CSF Kit intended for single-use or reusable applications?

The Optilite IgA CSF Kit is explicitly supplied as a single-use diagnostic reagent. This ensures consistency and reliability in test results while minimizing the risk of cross-contamination between samples.

What analyser is required to use the Optilite IgA CSF Kit?

The kit is designed specifically for use with the Optilite analyser, which is a nephelometric system optimized for immunoturbidimetric assays like this one.

How is the kit regulated, and what does that mean for its use?

The Optilite IgA CSF Kit is regulated under the In Vitro Diagnostic Regulation (IVDR) and holds FDA 510(k) clearance (K183151), meaning it has been deemed substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with safety and performance standards for diagnostic use in the U.S., though local regulations should always be verified for specific applications.

Are there specific storage instructions provided for the Optilite IgA CSF Kit?

The provided data does not specify storage conditions for the Optilite IgA CSF Kit. Clinicians should refer to the manufacturer’s instructions for proper storage to ensure the kit’s stability and performance, particularly regarding temperature, humidity, and shelf life.

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: Optilite™ Analyser | Binding Site - Thermo Fisher Scientific, Optilite IgA Kit (K191985) — FDA 510 (k) | Innolitics, Optilite IgA Kit 510 (k) K191985 - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

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

Sources (2)

  • FDA 510(k) K183151 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026