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Architect Total T3 MasterCheck is intended for use in the verification of sensitivity, calibration linearity, and reportable range of the Total T3 assay on the Abbott Architect i System.

Architect Total T3 MasterCheck Level 0 contains human serum.

Architect Total T3 MasterCheck Levels 1, 2, and 3 contain Total T3 prepared in human serum.

Preservative: Sodium Azide.

I am sorry, but the provided text appears to be a 510(k) summary for a diagnostic control device (Architect Total T3 MasterCheck) and does not contain information about studies proving the device meets acceptance criteria in the way described by your request (e.g., performance metrics like accuracy, sensitivity, specificity, or studies involving human readers or ground truth established by experts).

The document is a regulatory submission outlining:

• Device Name: Architect Total T3 MasterCheck
• Intended Use: Verification of sensitivity, calibration linearity, and reportable range of the Total T3 assay on the Abbott Architect i System.
• Classification: Class I, 75JJX CFR 862.1660: Single (Specified) Analyte Controls (Assayed and Unassayed).
• Predicate Device: Casco Standards Document Serum Multi-Analyte Verification Test Set (K950469).
• Technological Characteristics Comparison: A table comparing Architect Total T3 MasterCheck to the predicate device, highlighting similarities and some differences (like analytes and open vial claim).
• FDA Clearance: A letter from the FDA confirming substantial equivalence to a legally marketed predicate device.

This type of submission for a Class I control device typically focuses on demonstrating similarity to an existing device, manufacturing controls, and intended use, rather than extensive clinical performance studies that would involve establishing ground truth from patient data or evaluating human reader performance.

Therefore, I cannot provide the requested information as it is not present in the given text.

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