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ImmunoCAP Allergen F20 Almond Model 14-4179-01

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K100999

by Phadia AB

Identifiers

510(k) Number
K100999 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 ImmunoCAP Allergen F20 Almond Model 14-4179-01 is a System, Test, Radioallergosorbent (RAST) Immunological device designed for the in vitro diagnostic measurement of specific IgE antibodies to almond allergens. It employs a solid-phase allergen immunoassay technique to detect and quantify allergen-specific IgE in human serum or plasma, aiding in the diagnosis of allergic conditions.

This device is supplied as a single-use, pre-packaged test system intended for use in clinical laboratories or specialized immunology settings. It is authorized under the FDA 510K and IVDR frameworks, with a clearance type classified as Traditional. The test requires adherence to standard laboratory protocols for sample preparation, incubation, and analysis, ensuring accurate allergen-specific IgE detection. Sterility and proper storage conditions are maintained to preserve test integrity.

Frequently asked questions

What clinical purpose does the ImmunoCAP Allergen F20 Almond test serve in a lab setting?

This test is designed to measure specific IgE antibodies to almond allergens in human serum or plasma, helping clinicians diagnose allergic reactions or sensitivities to almonds. By quantifying allergen-specific IgE, it aids in confirming or ruling out almond allergy as part of broader allergy assessment protocols.

Is the ImmunoCAP Allergen F20 Almond single-use or reusable, and how should it be stored?

The test is supplied as a single-use, pre-packaged system, meaning each unit is intended for one analysis only. To maintain sterility and test integrity, it should be stored according to manufacturer guidelines—typically in a cool, dry place away from direct sunlight until use, as improper storage could compromise accuracy.

What regulatory pathways does the ImmunoCAP Allergen F20 Almond follow, and which committees reviewed it?

The device is authorized under both the FDA 510K pathway (with a *Traditional* clearance) and the In Vitro Diagnostic Regulation (IVDR). It was reviewed by the Immunology (IM) Advisory Committee during its FDA submission, which classified it as *Substantially Equivalent* to predicate devices in its category.

How does the ImmunoCAP Allmond test differ from other allergen tests in terms of methodology?

This test uses a solid-phase allergen immunoassay technique (a type of RAST assay) to detect IgE antibodies. Unlike skin prick tests or patch tests, it analyzes serum/plasma samples in vitro, providing quantitative results without patient exposure to allergens. This makes it suitable for patients with severe allergies or dermatological sensitivities.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Phadia AB

Sources (2)

  • FDA 510(k) K100999 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026