Advia 1650 Special Chemistry Calibrator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030804 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)
The Advia 1650 Special Chemistry Calibrator is a lyophilized human serum-based calibrator designed for use with the ADVIA 1650 Chemistry Analyzer. It serves as a multi-analyte mixture to establish reference values and ensure accuracy for clinical chemistry tests, including electrolytes, enzymes, and metabolites. This calibrator is specifically formulated to maintain precision and reliability in laboratory diagnostics.
Intended for use in clinical laboratory settings, the calibrator is reconstituted with 5.0 mL of distilled water before application on the ADVIA 1650 Chemistry Analyzer. Supplied as a single-use, sterile product, it is regulated under FDA 510(k) clearance (K030804) and classified as a Class II device. Storage and handling follow standard aseptic protocols for lyophilized diagnostic materials, ensuring stability and compliance with regulatory requirements.
Frequently asked questions
What is the Bayer Advia 1650 Special Chemistry Calibrator used for?
The Advia 1650 Special Chemistry Calibrator is a lyophilized human serum-based calibrator designed specifically for the ADVIA 1650 Chemistry Analyzer. It provides a multi-analyte mixture to establish accurate reference values for clinical chemistry tests, including electrolytes, enzymes, and metabolites. This ensures reliable and consistent results in laboratory diagnostics, maintaining precision for critical patient assessments.
How is the Advia 1650 Special Chemistry Calibrator supplied and prepared for use?
The calibrator is supplied as a single-use, sterile lyophilized vial. Before use, it must be reconstituted by adding 5.0 mL of distilled water. This preparation step is essential to ensure proper functionality and accuracy when applied to the ADVIA 1650 Chemistry Analyzer. Always follow aseptic protocols during reconstitution to maintain sterility and compliance with regulatory requirements.
Is the Advia 1650 Special Chemistry Calibrator sterile and intended for single-use?
Yes, the Advia 1650 Special Chemistry Calibrator is supplied as a sterile product and is designed for single-use only. Sterility is critical for clinical diagnostics to prevent contamination and ensure patient safety. After reconstitution and use, any remaining product should be discarded to comply with regulatory standards and maintain accuracy in laboratory testing.
What storage and handling instructions should be followed for this calibrator?
The Advia 1650 Special Chemistry Calibrator should be stored following standard aseptic protocols for lyophilized diagnostic materials. This typically includes keeping the vial in a cool, dry place, protected from light, and maintaining it within the specified temperature range (usually 2–8°C) until use. Avoid exposure to extreme temperatures or moisture, as these can compromise the product’s stability and performance. Always check the packaging for specific storage instructions before use.
What regulatory approval does the Advia 1650 Special Chemistry Calibrator hold?
The Advia 1650 Special Chemistry Calibrator is regulated under FDA 510(k) clearance with the clearance number K030804. It is classified as a Class II medical device and is intended for use in clinical laboratory settings to ensure accurate and reliable diagnostic results. The FDA clearance confirms that the device meets the regulatory requirements for safety and effectiveness as a substantially equivalent calibrator for the ADVIA 1650 Chemistry Analyzer.
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: Home | Bayer Global, Bayer Advia 1650 Special Chemistry Calibrator, PDF 603 0 6@/ - Food and Drug Administration, BAYER ADVIA 1650 SPECIAL CHEMISTRY CONTROL (K030801) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030804 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA 510(k) K030804 24 fields · synced Oct 5, 2026