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All Sebia's Hydragel ISO-CK kits are intended for the identification and quantitation of the three creatine kinase (CK) isoenzymes. MM. MB and BB. by electrophoresis on alkaline buffered agarose gels followed by a densitometry.

The creatine kinase (CK) isoenzyme, CK-MB, is primarily released from a damaged heart muscle. It is one of the earliest markers for distinguishing patients with acute myocardial infarction o(AMI) from those with other coronary syndromes and episodes with similar symptoms.

Biochemical assays have been, and remain so, the most reliable means of detecting myocardial injury. However, no single biochemical marker can alone give a complete picture of myocardial injury and its extent. Therefore, the assay of CK isoenzymes is often used in tandem with the assay of LD isoenzymes, which are released slower from the injured heart muscle and remain. Ionger in circulation, to confirm or rule out the diagnosis of MI, assess its severity and , monitor patient's condition.

The principles of HYDRAGEL ISO-CK assays are: the electrophoretic separation of the CK isoenzymes, the use of a specific chromogenic substrate for the CK catalyzed visualization reaction, and densitometric quantitation of the electrophoregrams.

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I apologize, but the provided text from the FDA 510(k) summary for the HYDRAGEL ISO-CK Kits does not contain the detailed study information required to answer your request.

The document is a letter from the FDA to the manufacturer, confirming the substantial equivalence of the device to a predicate device. It briefly describes the intended use and principles of the assay but does not present any specific acceptance criteria, performance data, or study methodologies.

Therefore, I cannot provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method.
5. Information on whether an MRMC comparative effectiveness study was done or its effect size.
6. Information on whether a standalone performance study was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

To obtain this information, you would typically need to refer to the full 510(k) submission, which usually includes detailed performance studies and clinical data. This document only presents the FDA's decision based on the submitted information.

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