← Back to catalogue

ImmunoCAP Allergen D201 House Dust Mite, Model 4-4896-01

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K092050

by Phadia AB

Identifiers

510(k) Number
K092050 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 D201 House Dust Mite, Model 4-4896-01, is an in vitro diagnostic device classified as a Radioallergosorbent Test (RAST) System. It is designed to measure specific IgE antibodies in human serum, enabling the detection and quantification of IgE-mediated hypersensitivity to house dust mite allergens (Der p I, Der p II, Der f I, Der f II). This diagnostic tool aids clinicians in identifying allergic sensitisation for targeted treatment planning.

This device is supplied as a single-use reagent kit and is intended for use in clinical laboratories or specialized immunology settings. It requires no special storage conditions beyond refrigeration at 2–8°C and is compatible with the ImmunoCAP System for automated processing. The device holds FDA 510(k) clearance under the Traditional pathway and is compliant with the In Vitro Diagnostic Regulation (IVDR). Model-specific codes and regulatory identifiers (e.g., K092050, DHB) ensure traceability and adherence to immunology practice standards.

Frequently asked questions

What clinical purpose does the ImmunoCAP Allergen D201 House Dust Mite test serve in patient care?

This test measures specific IgE antibodies in human serum to detect and quantify sensitivity to house dust mite allergens (Der p I, Der p II, Der f I, Der f II). Clinicians use the results to identify IgE-mediated hypersensitivity, helping guide targeted treatment plans like immunotherapy or allergen avoidance strategies.

Is the ImmunoCAP Allergen D201 House Dust Mite kit designed for single-use or repeated testing?

The kit is explicitly labeled as a single-use reagent, meaning each test strip or component is intended for one patient sample. This ensures accuracy and sterility, as reuse could compromise diagnostic reliability.

What storage conditions are required for the ImmunoCAP Allergen D201 House Dust Mite kit?

The kit does not require specialized storage beyond standard refrigeration at 2–8°C. This maintains stability and integrity until use, aligning with typical laboratory protocols for sensitive diagnostic reagents.

How is this device regulated, and what does that mean for its use in clinical settings?

The ImmunoCAP Allergen D201 holds both FDA 510(k) clearance under the Traditional pathway and compliance with the In Vitro Diagnostic Regulation (IVDR). This means it has undergone rigorous review for safety and performance, ensuring it meets established standards for in vitro diagnostic devices in immunology settings.

Can this test be used with any laboratory system, or is it compatible only with specific equipment?

The kit is designed specifically for use with the ImmunoCAP System, which automates processing. While it is not compatible with all laboratory systems, its integration with this platform ensures standardized, high-throughput testing for accurate IgE quantification.

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

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

Manufacturer

Manufacturer
Phadia AB

Sources (2)

  • FDA 510(k) K092050 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026