Automated In Vitro Quantitative Assay For The Measurement Of Allergen Specific …
FDA 510(k)Class II (US FDA 510(k))
by Phadia AB
Identifiers
- 510(k) Number
- K121156 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 Specific IgE Assay is an automated in vitro quantitative diagnostic test designed to measure allergen-specific immunoglobulin E (IgE) antibodies in human serum or plasma. Classified as a Radioallergosorbent Test (RAST) system, it aids in identifying IgE-mediated allergic conditions by detecting specific IgE levels against various allergens. This assay provides quantitative results, enabling precise clinical assessment of allergic sensitivities.
The assay is intended for use with Phadia instruments, including the Phadia 100, Phadia 250, Phadia 1000, Phadia 2500, and Phadia 5000 systems. It is supplied as a single-use diagnostic reagent and requires no special sterility conditions beyond standard laboratory practices. The device is regulated under FDA 510(k) clearance (K121156) and falls under Class II medical devices, adhering to regulatory standards for in vitro diagnostic use in immunology. Storage and handling follow manufacturer guidelines to maintain assay integrity.
Frequently asked questions
What is the ImmunoCAP IgE Assay used for?
The ImmunoCAP IgE Assay is an automated in vitro quantitative diagnostic test designed to measure allergen-specific immunoglobulin E (IgE) antibodies in human serum or plasma. It helps identify IgE-mediated allergic conditions by detecting specific IgE levels against various allergens, enabling precise clinical assessment of allergic sensitivities. This is particularly useful for diagnosing conditions like asthma, hay fever, or food allergies where IgE plays a key role.
Which instruments is this assay compatible with?
The ImmunoCAP IgE Assay is specifically designed for use with Phadia’s automated systems, including the Phadia 100, Phadia 250, Phadia 1000, Phadia 2500, and Phadia 5000. Compatibility with these instruments ensures seamless integration into clinical workflows for automated processing and quantitative results.
Is the ImmunoCAP IgE Assay single-use or reusable?
The ImmunoCAP IgE Assay is supplied as a single-use diagnostic reagent. This design ensures patient safety and consistency in results, as each test is intended for one use only. Single-use reagents also minimize the risk of cross-contamination and reduce the need for sterilization between uses.
What storage conditions are required for the assay?
The assay does not require special sterility conditions beyond standard laboratory practices. However, storage and handling should strictly follow the manufacturer’s guidelines to maintain assay integrity. Proper storage conditions typically include refrigeration (e.g., 2–8°C) and protection from light, as outlined in Phadia’s instructions to preserve reagent stability and accuracy.
How is the regulatory status of this assay determined?
The ImmunoCAP IgE Assay is regulated under the FDA’s 510(k) clearance process, specifically with clearance number K121156. It is classified as a Class II medical device and falls under the Radioallergosorbent Test (RAST) system category. The assay’s regulatory pathway ensures it meets stringent standards for in vitro diagnostic use in immunology, particularly for measuring allergen-specific IgE antibodies.
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: Automated in Vitro Quantitative Assay for The Measurement of Allergen ..., Automated In Vitro Quantitative Assay For The Measurement Of Allergen ..., Automated In Vitro Quantitative Assay For The Measurement Of Allergen ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121156 | Class II | Active |
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Manufacturer
- Manufacturer
- Phadia AB
Sources (1)
- FDA 510(k) K121156 24 fields · synced Oct 6, 2026