Linical Immunology Calibration Verifiers Levels A-E for Beckman Coulter Synchron CX Systems
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K030074 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)
Linical Immunology Calibration Verifiers Levels A-E for Beckman Coulter Synchron CX Systems are liquid, assayed controls used in clinical laboratories to verify calibration and linearity of Beckman Coulter Synchron CX systems. They are designed as multi-analyte mixtures in a human-serum protein matrix for objective verification of calibration and assessment of linearity regarding serum proteins.
These verifiers are supplied as ready-to-use liquid controls intended for storage at 2-8 °C. They are used in the clinical laboratory setting to support quality control procedures on Beckman Coulter Synchron CX systems. The device received FDA 510(k) clearance (K030074) and is classified as a Class II calibrator under regulation number 862.1150.
Frequently asked questions
What is the intended use of Linical Immunology Calibration Verifiers Levels A-E?
These verifiers are liquid, assayed controls used in clinical laboratories to verify calibration and assess linearity of Beckman Coulter Synchron CX systems. They are multi-analyte mixtures in a human-serum protein matrix designed for objective verification of calibration and linearity regarding serum proteins, supporting quality control procedures on the specified instrument.
How are Linical Immunology Calibration Verifiers Levels A-E supplied and stored?
The device is supplied as ready-to-use liquid controls intended for storage at 2-8 °C. This storage condition ensures stability of the assayed multi-analyte mixture in the human-serum protein matrix until use in the clinical laboratory setting for quality control on Beckman Coulter Synchron CX systems.
Are Linical Immunology Calibration Verifiers Levels A-E single-use or reusable?
The device description does not specify whether the verifiers are single-use or reusable. As liquid assayed controls supplied in vials for clinical laboratory use, they are typically intended for single-use per testing session to prevent contamination and ensure accurate verification of calibration and linearity, but reuse protocols would depend on laboratory-specific quality control policies and manufacturer instructions not detailed in the provided data.
What regulatory pathway was used for Linical Immunology Calibration Verifiers Levels A-E?
The device received FDA 510(k) clearance under submission number K030074, indicating it was found substantially equivalent to a legally marketed predicate device. It is classified as a Class II calibrator under regulation number 862.1150, with product code JIX, and the clearance type is traditional.
What specific system are Linical Immunology Calibration Verifiers Levels A-E designed for?
These verifiers are specifically designed for use with Beckman Coulter Synchron CX systems. They are formulated as multi-analyte mixtures in a human-serum protein matrix to verify calibration and assess linearity of these particular immunoanalyzers, supporting laboratory quality control procedures tailored to this instrument platform.
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: Linical Immunology Calibration Verifiers Levels A-e for Beckman Coulter ..., LiniCAL Calibration Verifiers, Linical Immunology Calibration Verifiers Levels A-e for Beckman Coulter ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K030074 | Class II | Active |
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Manufacturer
- Manufacturer
- Cliniqa Corporation
Sources (1)
- FDA 510(k) K030074 24 fields · synced Sep 24, 2026