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LiniCAL™ Immunology Calibration Verifiers Levels A – E for Beckman Coulter Synchron CX® Systems are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron CX® Systems. Five assayed levels are provided for IgA, IgG, IgM, TRF, ASO and PAB to allow monitoring of the reportable range.

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This document is an FDA 510(k) clearance letter for a medical device called LiniCAL™ Immunology Calibration Verifiers. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample sizes for test sets or their data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training sets was established.

The document primarily focuses on the regulatory clearance for marketing the device and its intended use as calibration verifiers. It does not delve into the performance evaluation data typically found in a scientific or technical study report.

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