← Back to catalogue

ImmunoCAP Allergen w1, Common Ragweed; ImmunoCAP Specific IgE

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K163370

by Phadia AB

Identifiers

510(k) Number
K163370 FDA 510(k)
FDA Product Code
DHB FDA 510(k)
Models / Variants
ImmunoCAP Allergen w1, Common ragweed FDA 510(k)EUDAMED
ImmunoCAP Specific IgE FDA 510(k)EUDAMED

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 ImmunoCAP Allergen w1, Common Ragweed; ImmunoCAP Specific IgE is an in vitro diagnostic device classified as a System, Test, Radioallergosorbent (Rast) Immunological. It is designed to measure allergen-specific IgE antibodies in human serum or plasma, utilising ImmunoCAPs covalently coupled with the specific allergen Common ragweed (w1).

This device is supplied as a diagnostic assay and is authorised under the FDA 510(k) pathway with clearance type Traditional, and meets IVDR requirements. It is intended for single-use in clinical immunology settings and requires no special storage conditions beyond those specified in the accompanying documentation. The product code DHB and registration numbers (e.g., 1036362) identify its regulatory classification and submission details.

Frequently asked questions

What clinical specialty is this device primarily intended for based on its regulatory classification?

This device is classified under the Immunology specialty, as indicated by its submission to the FDA’s Immunology (IM) Advisory Committee and the medical_specialty_description in regulatory records. It is designed for use in clinical settings where diagnosing allergen-specific IgE antibodies is relevant, such as allergy testing and patient management.

Is this device single-use, or can it be reused after testing?

The ImmunoCAP Allergen w1 is explicitly designed for single-use only. The device is supplied as a diagnostic assay kit, and reuse is not supported or authorized by the manufacturer or regulatory submissions.

What regulatory pathways does this device follow, and what does that mean for its use?

This device is authorized under the FDA 510(k) pathway with a Traditional clearance type, meaning it was compared to a legally marketed predicate device to demonstrate substantial equivalence. It also meets IVDR (In Vitro Diagnostic Regulation) requirements, ensuring compliance with European diagnostic standards. These pathways confirm its safety, performance, and intended use for measuring allergen-specific IgE antibodies in human serum or plasma.

Are there any special storage requirements for this device beyond standard lab conditions?

No special storage conditions are required beyond those outlined in the accompanying documentation. The device is intended for use in clinical immunology settings, where standard laboratory storage practices (e.g., temperature, humidity, and light protection) should be followed to maintain its integrity.

How is this device supplied, and what does the product code (DHB) indicate?

The ImmunoCAP Allergen w1 is supplied as a diagnostic assay kit for measuring allergen-specific IgE antibodies. The product code DHB is an administrative identifier used in regulatory submissions (e.g., FDA’s Product Classification Database) to categorize the device under System, Test, Radioallergosorbent (Rast) Immunological, ensuring proper tracking and classification for compliance purposes.

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: ImmunoCAP Allergen w1, Common ragweed - Thermo Fisher Scientific, ImmunoCAP Allergen w1, Common ragweed; ImmunoCAP Specific IgE, PDF ImmunoCAP Allergen W1, Common Ragweed; ImmunoCAP… - FDA.report

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Phadia AB

Sources (2)

  • FDA 510(k) K163370 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026