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Cardiac STATus™ Troponin I Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ Troponin I Rapid Test. These external controls compliment the monitoring of the test performance by the internal control provided in each test device.

Cardiac STATus™ Controls /Troponin I

The provided document is a 510(k) clearance letter from the FDA for a device called "Cardiac STATus™ Controls/Troponin I". This letter approves the marketing of the device, stating it is substantially equivalent to legally marketed predicate devices. However, the document does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details.

The document states the "Cardiac STATus™ Troponin I Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ Troponin I Rapid Test." This indicates the device is a control material, not the diagnostic test itself.

Therefore, I cannot provide the requested information from this document. The 510(k) summary submitted by the manufacturer (which is not provided here) would likely contain some of these details, particularly regarding the performance data that supported the substantial equivalence claim.

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