ImmunoCAP Allergen F338 Scallop (Model 14-4895-01)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Phadia AB
Identifiers
- 510(k) Number
- K071913 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 F338 Scallop (Model 14-4895-01) is a System, Test, Radioallergosorbent (RAST) Immunological device designed for the quantitative detection of allergen-specific IgE antibodies in human serum or plasma. It employs a fully automated fluoroenzyme immunoassay to identify IgE reactivity to scallop allergen (Pecten spp.), aiding in the diagnosis of allergic conditions.
This test package is supplied as a single-use component within the ImmunoCAP system, requiring no additional sterilisation. It is intended for use in clinical immunology laboratories and has received FDA 510K clearance and IVDR conformity. Each package contains 10 tests and must be stored under conditions specified in the accompanying documentation to maintain integrity. The device is classified under Device Class II and adheres to regulatory standards for in vitro diagnostic testing.
Frequently asked questions
What clinical purpose does the ImmunoCAP Allergen F338 Scallop test serve in diagnosing patient conditions?
The ImmunoCAP Allergen F338 Scallop test is designed for the quantitative detection of allergen-specific IgE antibodies in human serum or plasma. It helps identify IgE reactivity to scallop allergen (Pecten spp.), which aids clinicians in diagnosing allergic conditions related to scallop exposure, such as allergic rhinitis, asthma, or food allergies.
How is the ImmunoCAP Allergen F338 Scallop test supplied, and is it reusable?
The test is supplied as a single-use component within the ImmunoCAP system, packaged with 10 tests per unit. It does not require additional sterilization and is intended for one-time use in clinical immunology laboratories, ensuring patient safety and test accuracy.
What storage conditions must be followed to maintain the integrity of the ImmunoCAP Allergen F338 Scallop test?
The test must be stored according to the instructions provided in the accompanying documentation. While the exact conditions aren’t detailed here, proper storage typically involves protecting it from extreme temperatures, humidity, and light to preserve its performance and reliability for quantitative IgE detection.
What regulatory pathways has the ImmunoCAP Allergen F338 Scallop test undergone, and what does that mean for its use?
The test has received FDA 510(k) clearance and IVDR (In Vitro Diagnostic Regulation) conformity, confirming its compliance with U.S. and EU regulatory standards for in vitro diagnostic devices. This means it meets established safety, performance, and quality requirements for use in clinical immunology laboratories.
Is this test compatible with automated systems, and how does it integrate into laboratory workflows?
Yes, the ImmunoCAP Allergen F338 Scallop test is designed for use within the fully automated ImmunoCAP system. This integration allows for streamlined workflows, automated processing of samples, and consistent quantitative detection of IgE antibodies, reducing manual handling and potential errors in clinical settings.
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: ImmunoCAP Allergen f338, Scallop - Thermo Fisher Scientific, ImmunoCAP Allergen f338, Scallop | Thermo Fisher Scientific, Immunocap Allergen F338, Scallop With Model (S): 14-4895-01
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 | K071913 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Phadia AB
Sources (2)
- FDA 510(k) K071913 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026