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CLINIQA LiniCAL™ Esoterics Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron® Analyzers. Five assayed levels of AMM (ammonia), ETOH (alcohol), MA (microalbumin), M-TP (microprotein) and SALY (salicylate) are provided to allow monitoring of the reportable range.

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This document is a 510(k) premarket notification letter from the FDA for a device called "LiniCAL™ Esoterics Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Analyzers." This is a quality control material used to verify calibration and assess linearity of clinical analyzers.

The provided text does not contain the detailed study information required to answer your request. It primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices. It does not include:

• A table of acceptance criteria or reported device performance.
• Information about sample sizes, data provenance, or ground truth establishment.
• Information about expert involvement, adjudication methods, or MRMC studies.
• Details on standalone algorithm performance or training sets.

Therefore, I cannot provide the requested information based on the given document. This document is a regulatory approval letter, not a study report.

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