Phadia Prime System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Phadia AB
Identity
- Trade Name
- Phadia Prime EUDAMEDFDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Phadia Prime EUDAMEDFDA UDI
- Model / Reference
- 12-4101-00 EUDAMEDFDA UDI
- Description
- Phadia Prime FDA UDI
Identifiers
- Catalog Number
- 12-4101-00 FDA UDI
- Primary DI / UDI-DI
- 07333066015101 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0016LV EUDAMED
- 510(k) Number
- FDA Product Code
- DHB FDA 510(k)FDA UDI
- EMDN Code
- W0201020192 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.5750 FDA 510(k)
- Regulation Number
- 866.5750 FDA 510(k)FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden EUDAMED
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
No
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Phadia Prime System is an in vitro diagnostic device classified as a Radioallergosorbent Test (RAST) Immunological System. It is designed for the quantitative measurement of specific IgE antibodies in human serum or plasma, enabling the diagnosis and monitoring of allergic conditions such as asthma, hay fever, and food allergies.
This system is supplied as a reagent kit for laboratory use and is intended for single-use only. It operates under in vitro diagnostic regulations, including FDA 510(k) clearance and IVDR compliance, with a classification as a Class II device. The system requires proper storage at controlled temperatures and adherence to manufacturer instructions for handling and disposal to ensure accuracy and reliability.
Frequently asked questions
What types of allergic conditions can the Phadia Prime System help diagnose or monitor?
The Phadia Prime System is designed for the quantitative measurement of specific IgE antibodies in human serum or plasma, which helps in diagnosing and monitoring allergic conditions such as asthma, hay fever (seasonal allergies), and food allergies. By detecting specific IgE levels, clinicians can assess the likelihood of allergic reactions to triggers like pollen, dust mites, or certain foods.
Is the Phadia Prime System intended for single-use or repeated use in a laboratory setting?
The Phadia Prime System is supplied as a reagent kit for laboratory use and is explicitly intended for single-use only. This ensures accuracy and reliability, as reuse could compromise test integrity or introduce contamination risks. Always follow the manufacturer’s instructions for proper handling and disposal.
What storage conditions are required for the Phadia Prime System to maintain its performance?
The Phadia Prime System must be stored under controlled temperatures as specified by the manufacturer. While the exact temperature range isn’t detailed here, proper storage is critical to preserve reagent stability and ensure accurate IgE measurement results. Always refer to the included instructions for precise storage guidelines.
How is the Phadia Prime System regulated, and what does that mean for its use in clinical settings?
The Phadia Prime System holds FDA 510(k) clearance and complies with the In Vitro Diagnostic Regulation (IVDR), classifying it as a Class II device. This means it has undergone regulatory review to demonstrate substantial equivalence to a predicate device and meets safety and performance standards for laboratory use in diagnosing allergic conditions. Clinicians can rely on its compliance for reliable diagnostic support.
Are there multiple versions or sizes of the Phadia Prime System, or does it come as a unified kit?
The Phadia Prime System is supplied as a reagent kit, but the data includes multiple FEI numbers and registration numbers, suggesting it may encompass various allergen-specific test components (e.g., for pollen, food, or environmental allergens). While not explicitly listed as
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 | K151029 | Class II | Active |
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Manufacturer
- Manufacturer
- Phadia AB
Sources (3)
- FDA 510(k) K151029 24 fields · synced Sep 18, 2026
- FDA UDI 10f2a0e3-ab8e-4745-96a5-6572b58be25a 36 fields · synced May 30, 2026
- EUDAMED 4bf7f4d7-6f56-4c0b-889a-bb7cfff99b73 61 fields · synced Jul 17, 2026