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Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002,…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191510

by Hycor Biomedical

Identifiers

510(k) Number
K191510 FDA 510(k)
FDA Product Code
DHB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5750 FDA 510(k)
Regulation Number
866.5750 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Noveos Immunoanalyzer System is a Test, Radioallergosorbent (Rast) Immunological device designed for in vitro measurement of allergen-specific immunoglobulin E (IgE) antibodies in human serum. This system employs fluorescent-labeled magnetic microparticles and biotinylated allergenic capture reagents to detect and quantify IgE levels, aiding in the diagnosis of allergic conditions such as asthma, rhinitis, or dermatitis. The Capture Reagent D002 specifically targets Dermatophagoides farinae, a common indoor allergen, enabling targeted allergen-specific testing within the immunoassay workflow.

The device is intended for use in immunology laboratories and operates as a single-use reagent within the Noveos Immunoanalyzer System, requiring no additional sterilization. It is classified under FDA 510(k) clearance (K191510) as substantially equivalent to predicate devices, adhering to regulatory standards for in vitro diagnostics (regulation number 866.5750). Supplied as a pre-filled reagent, it must be stored under controlled conditions to maintain stability, with compatibility confirmed for use in Class II (non-electrical) medical devices. No MRI safety considerations apply, and the system is intended for professional use only.

Frequently asked questions

What specific type of allergen does the Capture Reagent D002 test for, and how does it fit into the Noveos Immunoanalyzer System workflow?

The Capture Reagent D002 is designed to detect allergen-specific immunoglobulin E (IgE) antibodies against *Dermatophagoides farinae*, a common indoor allergen linked to conditions like asthma, rhinitis, or dermatitis. It works within the Noveos Immunoanalyzer System by using biotinylated allergenic capture reagents alongside fluorescent-labeled magnetic microparticles to quantify IgE levels in human serum, enabling targeted allergen-specific testing as part of the immunoassay process.

Is the Capture Reagent D002 intended for single-use or repeated use, and what storage conditions are required to maintain its stability?

The Capture Reagent D002 is explicitly designed for single-use within the Noveos Immunoanalyzer System, eliminating the need for sterilization between uses. To preserve stability, it must be stored under controlled conditions as specified by the manufacturer, though exact details (e.g., temperature, humidity) are not provided in the data—always refer to the accompanying documentation for precise storage instructions.

How is this reagent supplied, and what compatibility considerations should laboratories take into account when integrating it into their workflow?

The Capture Reagent D002 is supplied as a pre-filled reagent, ready for immediate use in the Noveos Immunoanalyzer System. Laboratories should confirm compatibility with Class II (non-electrical) medical devices and ensure the system meets the device’s regulatory requirements (e.g., FDA 510(k) clearance under K191510). No MRI safety concerns are noted, but professional use is mandatory, as it is intended exclusively for immunology laboratories.

What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

The Noveos Immunoanalyzer System and its Capture Reagent D002 received FDA 510(k) clearance (K191510) under the Traditional 510(k) Review pathway, with a decision of *Substantially Equivalent* to predicate devices. The review was conducted by the Immunology (IM) Advisory Committee, reflecting its classification under FDA regulation number 866.5750 for in vitro diagnostic devices. This clearance confirms compliance with U.S. regulatory standards for immunological testing.

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: Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture ..., NOVEOS | IgE Allergy Testing Equipment | HYCOR Biomedical, PDF Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hycor Biomedical

Sources (1)

  • FDA 510(k) K191510 24 fields · synced Sep 19, 2026