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1. The Thermo Electron Infinity™ ACE Reagent Kit is intended for the quantitative determination of ACE in human serum or plasma. The product is for in vitro diagnostic use only. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher`s disease, a hereditary disorder affecting the spleen.
2. The Thermo Electron Infinity™ ACE Calibrator is intended for the calibration of ACE assays. The product is for in vitro diagnostic use only.
3. The Thermo Electron ACE Normal and Elevated Controls are intended for monitoring the accuracy and precision of ACE assays. The product is for in vitro diagnostic use only.

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This document is a 510(k) premarket notification for in vitro diagnostic devices. It does not contain information about an AI/ML-based device or a study that uses acceptance criteria and device performance as typically understood for AI/ML or imaging devices. The devices described are reagent kits, calibrators, and controls for measuring Angiotensin Converting Enzyme (ACE) in human serum or plasma.

Therefore, I cannot extract the requested information from the provided text as it is not relevant to AI/ML or imaging device studies.

However, if this were an AI/ML or imaging device submission, the requested information would typically be found in sections detailing clinical study results, performance validation, or substantial equivalence comparisons, which are absent in this specific document.

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