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Elecsys CalCheck FT4 is intended for use in the quantitative verification of the calibration curve established by the Elecsys FT4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.

The Elecsys CalCheck FT4 is a three level single analyte set of lyophilized, human based materials. After reconstitution they are assayed in triplicate and the results are compared to the target values.

The provided text describes a 510(k) summary for a medical device called "Elecsys® CalCheck™ FT4". However, it does not contain any information regarding acceptance criteria, device performance, sample sizes, expert involvement, or study details.

The document focuses on:

• Introduction and Submitter Information: Basic details about the submission, company, and contact person.
• Device Name: Proprietary and common names, and classification.
• Predicate Device: Identification of a substantially equivalent device (Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862).
• Device Description: A brief description of Elecsys CalCheck FT4 as a three-level, lyophilized, human-based material for calibration verification.
• Intended Use: Specifically states its purpose for quantitative verification of the calibration curve established by Elecsys FT4 reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
• Comparison to Predicate Device: Reaffirms substantial equivalence based on intended use.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert details, or study information as this data is entirely absent from the provided text.

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