ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Phadia AB
Identifiers
- 510(k) Number
- K173726 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, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut is an in vitro diagnostic device classified as a Radioallergosorbent Test (RAST) system. It is designed to measure specific immunoglobulin E (IgE) antibodies in human serum or plasma, enabling the detection and quantification of allergen-specific IgE to peanut allergen component rAra h 6.
This device is intended for use in clinical immunology laboratories and is supplied as a diagnostic kit. It is intended for single-use and requires no sterilisation beyond manufacturer-provided packaging. The device is authorised under the FDA 510K pathway and meets In Vitro Diagnostic Regulation (IVDR) standards. Storage conditions and regulatory compliance are specified in the manufacturer’s instructions, ensuring accurate and reliable allergen-specific IgE testing.
Frequently asked questions
What clinical specialty is this device intended for, and how does it help in diagnosis?
This device is specifically intended for use in clinical immunology laboratories, as indicated by its classification as a Radioallergosorbent Test (RAST) system and the associated medical specialty description. It measures specific immunoglobulin E (IgE) antibodies in human serum or plasma to detect and quantify allergen-specific IgE to the peanut allergen component rAra h 6. This aids in diagnosing peanut allergies by providing objective, quantitative results to support clinical decision-making.
Is this test kit designed for single-use, and if so, what does that mean for handling and storage?
Yes, this device is explicitly designed for single-use only, meaning each kit is intended for one test procedure and should not be reused. This ensures accuracy and safety, as reuse could compromise sterility or introduce contamination. The manufacturer’s packaging provides the necessary sterility, so no additional sterilization is required beyond opening the kit under controlled conditions. Proper storage (as detailed in the manufacturer’s instructions) is critical to maintaining the kit’s integrity until use.
What regulatory pathways does this device follow, and how does that affect its use in clinical settings?
This device is authorized through the FDA 510K pathway, meaning it has been deemed substantially equivalent to a predicate device, and it also complies with In Vitro Diagnostic Regulation (IVDR) standards. These pathways ensure the device meets rigorous safety, performance, and quality requirements before clinical use. Clinicians can rely on its regulatory compliance for accurate and reliable allergen-specific IgE testing, as validated by the Immunology Advisory Committee (IM) during the review process.
How is this test kit supplied, and what should clinicians expect when ordering or receiving it?
The ImmunoCAP Specific IgE kit is supplied as a diagnostic kit tailored for use in clinical immunology laboratories. It is packaged to ensure sterility and single-use functionality, with no additional sterilization needed beyond the manufacturer’s protective measures. Clinicians should expect a standardized format for testing peanut allergen-specific IgE (rAra h 6), including all necessary reagents and components for the RAST procedure. Storage conditions and handling instructions are provided by the manufacturer to preserve the kit’s performance until use.
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
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K173726 | Class II | Active |
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Manufacturer
- Manufacturer
- Phadia AB
Sources (2)
- FDA 510(k) K173726 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026