Alkaline Phosphatase (IFCC) Plus
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- eCal EUDAMEDAlkaline Phosphatase (IFCC) Plus EUDAMED
- Device Name
- eCal EUDAMEDAlkaline Phosphatase (IFCC) Plus EUDAMED
- Model / Reference
- 981830 EUDAMED981832 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16438153818301 EUDAMED16438153818325 EUDAMED
- Basic UDI-DI
- 6438153BU00054BQ EUDAMED6438153BU00156BZ EUDAMED
- Direct Marketing DI
- 16438153818301 EUDAMED16438153818325 EUDAMED
- 510(k) Number
- K073191 FDA 510(k)
- FDA Product Code
- CJE FDA 510(k)
- EMDN Code
- W0101050301 CALIBRATORS MULTICOMPONENT (CC) EUDAMEDW01010105 ALKALINE PHOSPHATASE - TOTAL EUDAMED
Classification
- Device Class
- Class C EUDAMEDClass B EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1050 FDA 510(k)
- Regulation Number
- 862.1050 FDA 510(k)
- Market of Registration
- Finland EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Human Tissues
Yes
Animal Tissues
No
Microbial Substances
No
Reagent
Yes
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
The Alkaline Phosphatase (IFCC) Plus is a diagnostic reagent used for measuring alkaline phosphatase activity in serum or plasma samples, adhering to the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) standard. It is designed for use in clinical chemistry analyzers to assess liver function, bone metabolism, and other physiological conditions where alkaline phosphatase levels are clinically relevant.
This reagent is supplied as a ready-to-use liquid for in vitro diagnostic use, intended for single-use applications in clinical laboratories. It is authorized under FDA 510(k) clearance and IVDR compliance, with a classification as a Class II device (regulation number 862.1050). Storage and handling follow standard laboratory protocols for diagnostic reagents, ensuring stability and accuracy of results.
Frequently asked questions
What clinical conditions is this reagent primarily used to evaluate, and how does it contribute to diagnosis?
This reagent measures alkaline phosphatase (ALP) activity following the IFCC standard, which is critical for assessing liver function, bone metabolism, and other physiological conditions. Elevated ALP levels can indicate liver disease (e.g., cholestasis), bone disorders (e.g., Paget’s disease or rickets), or metabolic bone disease. By quantifying ALP activity in serum or plasma, clinicians can monitor these conditions and guide treatment decisions.
Is this reagent single-use, and if so, how should it be handled to maintain accuracy?
Yes, the Alkaline Phosphatase (IFCC) Plus reagent is designed for single-use only in clinical laboratories. It is supplied as a ready-to-use liquid, so proper handling includes storing it under standard laboratory conditions (typically refrigerated or as specified by the manufacturer) to preserve stability and prevent contamination. Always follow the manufacturer’s instructions for reconstitution (if applicable) and expiration to ensure reliable test results.
What regulatory pathways does this device follow, and how does that affect its use in clinical settings?
This reagent is authorized under FDA 510(k) clearance (K073191) and complies with the In Vitro Diagnostic Regulation (IVDR) in the EU, classified as a Class II device (regulation 862.1050). These pathways ensure it meets stringent performance and safety standards for use in clinical chemistry analyzers. Clinicians can rely on its regulatory status to confirm its suitability for measuring ALP activity in serum/plasma, though local laboratory protocols and compliance with manufacturer guidelines remain essential for accurate testing.
Are there multiple reagent sizes or models available, or is this a standardized single formulation?
The provided data does not specify distinct sizes or models beyond the Alkaline Phosphatase (IFCC) Plus designation, which is supplied as a ready-to-use liquid for clinical chemistry analyzers. It appears to be a standardized formulation intended for general use in laboratories measuring ALP activity. For exact lot sizes or packaging variations, refer to the manufacturer’s current product documentation or technical data sheets.
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 | K073191 | Class II | Active |
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Manufacturer
- Manufacturer
- Thermofisher Scientific OY
Sources (3)
- FDA 510(k) K073191 24 fields · synced Oct 6, 2026
- EUDAMED 1446c193-df28-46e6-9446-e9a66077300d 61 fields · synced Jul 29, 2026
- EUDAMED 5fe34372-df3c-490a-a528-40b9b6b71926 61 fields · synced Jul 29, 2026