ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Co…
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Phadia AB
Identity
- Trade Name
- ImmunoCAP Tryptase Curve Control Strip EUDAMEDFDA UDI
- Generic Name
- Mast cell protease IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ImmunoCAP Tryptase EUDAMEDImmunoCAP Tryptase Curve Control Strip FDA UDI
- Model / Reference
- 10-9524-01 EUDAMED34-2342-31 FDA UDI
- Description
- ImmunoCAP Tryptase Curve Control Strip FDA UDI
Identifiers
- Catalog Number
- 34-2342-31 FDA UDI
- Primary DI / UDI-DI
- 07333066012551 EUDAMEDFDA UDI
- Basic UDI-DI
- 7333066BUDI0011LK EUDAMED
- 510(k) Number
- FDA Product Code
- OYL FDA 510(k)FDA UDI
- EMDN Code
- W01020299 ALLERGY TESTS - OTHER EUDAMED
- GMDN Term
- Mast cell protease IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 866.5760 FDA 510(k)
- Regulation Number
- 866.5760 FDA 510(k)FDA UDI
- 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
Yes
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
Yes
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
Yes
Manufacturing Date
No
The ImmunoCAP Tryptase Assay System is an in vitro diagnostic device designed for the quantitative measurement of human tryptase in serum or plasma. It employs a fluorescence enzyme immunoassay technique to detect and quantify tryptase levels, aiding in the diagnosis and monitoring of conditions such as mastocytosis and anaphylaxis.
This system is supplied as a kit containing reagents, including ImmunoCAP Tryptase, calibrators, curve controls, conjugate, and strip formats, intended for use in clinical laboratories. Authorized under FDA 510(k) clearance and IVDR compliance, it is classified as a Class II device and requires adherence to standard laboratory practices for handling, storage, and single-use procedures. The assay is intended for professional use only and must be performed according to the provided instructions.
Frequently asked questions
What clinical conditions is the ImmunoCAP Tryptase Assay System primarily used to diagnose or monitor?
The ImmunoCAP Tryptase Assay System is designed for the quantitative measurement of human tryptase in serum or plasma, which aids in diagnosing and monitoring conditions like mastocytosis and anaphylaxis. Elevated tryptase levels are often associated with these conditions, making this assay useful for clinical evaluation in immunology settings.
How is the ImmunoCAP Tryptase Assay System supplied, and what components are included in the kit?
The system is supplied as a kit containing multiple reagents, including ImmunoCAP Tryptase, calibrators (both liquid and strip formats), curve controls (liquid and strip formats), and ImmunoCAP Tryptase Conjugate. These components are intended for use in clinical laboratories to perform fluorescence enzyme immunoassays for tryptase quantification.
Is the ImmunoCAP Tryptase Assay System intended for single-use only, and what storage requirements apply?
Yes, the ImmunoCAP Tryptase Assay System is intended for single-use only, adhering to standard laboratory practices. While the exact storage conditions are detailed in the provided instructions, most immunoassay reagents require refrigeration (typically 2–8°C) and protection from light to maintain stability and performance.
What regulatory pathways does the ImmunoCAP Tryptase Assay System follow, and how is it classified?
The ImmunoCAP Tryptase Assay System is authorized under both FDA 510(k) clearance and IVDR compliance, indicating it meets regulatory standards for in vitro diagnostics in the U.S. and European markets. It is classified as a Class II device, which requires adherence to specific manufacturing and quality control standards.
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 | K173704 | Class II | Active |
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Manufacturer
- Manufacturer
- Phadia AB
Sources (3)
- FDA 510(k) K173704 24 fields · synced Sep 18, 2026
- FDA UDI 05ef50a0-01b7-4ad7-b4f3-ddeb432df295 37 fields · synced May 30, 2026
- EUDAMED f033b3a4-b7f6-4954-af57-9f2214e044e5 61 fields · synced Jul 23, 2026