Uric Acid (AOX) Calibrator, Multi-Analyte Mixture
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K073612 FDA 510(k)
- FDA Product Code
- JIX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1150 FDA 510(k)
- Regulation Number
- 862.1150 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Calibrator, Multi-Analyte Mixture designed for use in clinical chemistry. It provides standardized reference values for uric acid (AOX) and other analytes, ensuring accurate measurement calibration in automated clinical chemistry analyzers. The calibrator supports precise quantification of uric acid levels in patient samples, aiding in diagnostic assessments for conditions such as gout, kidney disease, and metabolic disorders.
The calibrator is supplied as a liquid reagent intended for single-use in laboratory settings. It is not sterile and requires proper handling, storage at controlled temperatures (typically 2–8°C), and adherence to manufacturer instructions for preparation and use. Authorized under FDA 510K, IVDD, and IVDR, this device complies with regulatory standards for in vitro diagnostic reagents. Multiple reference codes (e.g., 3002808140, 3006198300) identify compatible analyzer systems, ensuring compatibility with clinical chemistry workflows.
Frequently asked questions
What clinical conditions is this calibrator designed to support in diagnostic assessments?
This calibrator is specifically designed to provide standardized reference values for uric acid (AOX) measurement, which aids in diagnosing conditions like gout, kidney disease, and metabolic disorders. By ensuring accurate calibration in automated clinical chemistry analyzers, it helps clinicians quantify uric acid levels reliably for these diagnostic purposes.
Is this calibrator compatible with multiple types of clinical chemistry analyzers, and how do I verify compatibility?
Yes, this calibrator is compatible with a wide range of clinical chemistry analyzers, as indicated by its extensive list of FEI numbers (e.g., 3002808140, 3006198300). To verify compatibility, check if your analyzer’s FEI number appears in the provided list. This ensures seamless integration into your laboratory workflow.
How should I store this calibrator, and what are the implications of improper storage?
The calibrator must be stored at 2–8°C to maintain stability and accuracy. Improper storage—such as exposure to higher temperatures or freezing—could degrade its performance, leading to inaccurate uric acid measurements. Always follow the manufacturer’s instructions to preserve its integrity.
Can this calibrator be reused, or is it intended for single-use only?
This calibrator is explicitly designed for single-use only in laboratory settings. Reusing it could compromise accuracy and introduce contamination risks, potentially affecting diagnostic reliability. Always use a fresh vial per calibration cycle.
What regulatory pathways does this calibrator follow, and how does that affect its use in clinical settings?
The calibrator is authorized under FDA 510K, IVDD, and IVDR pathways, meaning it meets stringent regulatory standards for in vitro diagnostic reagents. This ensures compliance with global and U.S. clinical chemistry requirements, providing confidence in its reliability for accurate uric acid calibration in licensed laboratories.
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
IVDD
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K073612 | Class II | Active |
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Manufacturer
- Manufacturer
- Thermofisher Scientific OY
Sources (2)
- FDA 510(k) K073612 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026