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PreciControl Cardiac is used for quality control of the Elecsys CK-MB, Digoxin, Myoglobin, and NT-proBNP immunoassays on the Elecsys immunoassay systems.

Roche Diagnostics Elecsys® PreciControl Cardiac is a bilevel lyophilized preparation of pooled human sera containing CK-MB, Digoxin, Myoglobin, and NT-proBNP for monitoring accuracy and precision on Elecsys immunoassay analyzers.

The provided text is a 510(k) summary for a medical device called "Elecsys® PreciControl Cardiac," which is a quality control material. It describes the device, its intended use, and claims substantial equivalence to a previously marketed predicate device.

However, the document does not contain any information about acceptance criteria or a study that proves the device meets such criteria. This type of information would typically include performance metrics, statistical analysis, and details about clinical or laboratory studies.

Therefore, I cannot provide the requested information from the given text. The text primarily focuses on regulatory submission details and a comparison to a predicate device, rather than detailed performance study results.

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