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Allergen Immunocap (D73 +18 more) - F96

FDA 510(k)

Class II (US FDA 510(k))

510(k) K982343

by Pharmacia & Upjohn Co.

Identifiers

510(k) Number
K982343 FDA 510(k)
FDA Product Code
DHB FDA 510(k)
Models / Variants
D73 FDA 510(k)
D74 FDA 510(k)
E71 FDA 510(k)
E72 FDA 510(k)
E73 FDA 510(k)
E74 E75 FDA 510(k)
E76 FDA 510(k)
E82 FDA 510(k)
E88 FDA 510(k)
F48 FDA 510(k)
F90 FDA 510(k)
F92 FDA 510(k)
F96 FDA 510(k)
F201 FDA 510(k)
F215 FDA 510(k)
M70 FDA 510(k)
T17 FDA 510(k)
T72 FDA 510(k)
3 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 Allergen Immunocap Models are in-vitro diagnostic devices classified as Radioallergosorbent (RAST) Immunological Systems. These tests measure specific Immunoglobulin E (IgE) antibodies in patient serum to aid in diagnosing IgE-mediated allergic disorders. Each model is designed to detect allergies to specific substances, such as pollen, dust mites, or food allergens, by quantifying allergen-specific IgE levels. The device operates on the principle of allergen-specific binding to immobilized allergens on solid-phase carriers, enabling sensitive detection of IgE antibodies.

These models are intended for use in clinical laboratories and require professional handling. Supplied as single-use kits, they include pre-coated Immunocap test elements and necessary reagents for testing. The device is regulated under FDA 510(k) clearance (K982343) and falls under the Device Classification Name: System, Test, Radioallergosorbent (RAST) Immunological. Storage conditions and expiration dates are specified on the packaging, ensuring proper handling and sterility. Each model number corresponds to a distinct allergen panel, with no reusable components.

Frequently asked questions

What is the Allergen Immunocap used for?

The Allergen Immunocap Models (D73, D74, E71, etc.) are in-vitro diagnostic devices designed to measure specific Immunoglobulin E (IgE) antibodies in patient serum. These tests help diagnose IgE-mediated allergic disorders by quantifying allergen-specific IgE levels, such as those triggered by pollen, dust mites, or food allergens. The device uses allergen-specific binding to immobilized allergens on solid-phase carriers for sensitive detection.

How is the Allergen Immunocap supplied and intended for use?

The Allergen Immunocap Models are supplied as single-use kits, including pre-coated Immunocap test elements and necessary reagents. They are intended exclusively for professional handling in clinical laboratories. Each model corresponds to a distinct allergen panel, ensuring targeted testing without reusable components, which helps maintain sterility and accuracy.

Are the Immunocap test elements reusable?

No, the Immunocap test elements are strictly single-use components. This design ensures each test is performed under controlled, sterile conditions, reducing the risk of contamination or cross-reactivity between patients. Reusable components are not part of the device’s construction or intended use.

How should the Immunocap Models be stored?

Storage conditions and expiration dates are clearly indicated on the packaging of each Immunocap model. Proper storage is essential to preserve sterility and test accuracy. Follow the manufacturer’s instructions on the packaging to maintain optimal performance until the expiration date.

What regulatory clearance does the Allergen Immunocap have?

The Allergen Immunocap Models hold FDA 510(k) clearance under the classification of Radioallergosorbent (RAST) Immunological Systems. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets regulatory requirements for safety and effectiveness in diagnosing IgE-mediated allergies.

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: Allergen Immunocap Models D73, D74, E71, E72, E73, E74 E75, E76,E82,E88 ..., Allergen Immunocap Models D73, D74, E71, E72, E73, E74 E75, E76,e82,e88 ..., K982343 FDA 510(k) - ALLERGEN IMMUNOCAP MODELS D73, www.accessdata.fda.gov

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pharmacia & Upjohn Co.

Sources (1)

  • FDA 510(k) K982343 24 fields · synced Oct 1, 2026