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AIA-PACK Myoglobin is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of myoglobin in human serum and plasma on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis and monitoring of cardiac disease.

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This document is a 510(k) clearance letter from the FDA for the AIA-PACK Myoglobin Assay manufactured by Tosoh Medics, Inc. It grants clearance for the device, stating it is substantially equivalent to legally marketed predicate devices.

However, this document does NOT contain the following information that you requested:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or their data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• Type of ground truth used.
• Sample size for and establishment of ground truth for training sets.

The letter explicitly states the intended use of the device: "AIA-PACK Myoglobin is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of myoglobin in human serum and plasma on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis and monitoring of cardiac disease."

To obtain the information you are seeking, you would need to consult the original 510(k) submission (K981012) from Tosoh Medics, Inc. to the FDA, which would detail the studies and data used to demonstrate substantial equivalence. This clearance letter is merely the FDA's approval of that submission.

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