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Allergen Immundocap Modelc5, C6, C73, E201, E213, F50, F51, F54, F55, F56, F57,…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K993388

by Pharmacia & Upjohn Co.

Identifiers

510(k) Number
K993388 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 Allergen ImmunoCAP is a solid-phase component of an in vitro immunodiagnostic system designed for the quantitative measurement of specific immunoglobulin E (IgE) antibodies to individual allergens. It functions as a radioallergosorbent test (RAST) system, enabling the detection and assessment of allergic sensitivities through allergen-specific binding.

This device is supplied as a single-use diagnostic reagent for in vitro laboratory testing, intended for use in clinical immunology settings. It requires FDA 510(k) clearance and is classified as a Class 2 medical device under the regulatory category for immunological testing. Models are identified by specific reference codes and are not intended for MRI use or reusable applications.

Frequently asked questions

What specific types of allergens can the ImmunoCAP test for, and how are the different models distinguished?

The ImmunoCAP system is designed to measure specific immunoglobulin E (IgE) antibodies to individual allergens, enabling detection of allergic sensitivities. Each model (e.g., C5, F50, E201) corresponds to a distinct allergen or allergen group, as identified by the reference codes listed. These models are not interchangeable and must be selected based on the specific allergen being tested in the clinical setting.

Is the ImmunoCAP device intended for reuse, or is it meant to be used only once per test?

The ImmunoCAP is explicitly supplied as a single-use diagnostic reagent. It is designed for in vitro laboratory testing and must not be reused, as reuse could compromise accuracy and patient safety. Each test requires a new ImmunoCAP component.

What regulatory pathway was followed for the ImmunoCAP’s clearance, and what class does it fall under?

The ImmunoCAP underwent a traditional 510(k) clearance process through the FDA, demonstrating substantial equivalence to a predicate device. It is classified as a Class 2 medical device under the regulatory category for immunological testing, specifically for radioallergosorbent (RAST) systems.

Can the ImmunoCAP be used in an MRI environment, or are there any restrictions on its use?

The ImmunoCAP is not intended for use in MRI environments. The device’s specifications explicitly state it is not designed for MRI compatibility, so it should be used in non-MRI settings only.

How is the ImmunoCAP supplied, and what type of laboratory setting is it intended for?

The ImmunoCAP is supplied as a single-use diagnostic reagent for in vitro laboratory testing. It is intended for use in clinical immunology settings, where trained personnel can perform quantitative measurements of allergen-specific IgE antibodies. The device requires specialized laboratory equipment and expertise.

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 Immundocap Modelc5, C6, C73, E201, E213, F50, F51,F54, F55 ..., K993388 FDA 510(k) - ALLERGEN IMMUNDOCAP MODELC5, PDF K993388 Allergen Immundocap Modelc5, C6, C73, E201, E213, F50, F51,F54 ..., K991048 FDA 510(k) - ALLERGEN IMMUNOCAP | Pharmacia & Upjohn Co.

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) K993388 24 fields · synced Oct 6, 2026