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

The Elecsys CalCheck T Uptake 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.

This document is a 510(k) summary for a medical device called "Elecsys® CalCheck™ T Uptake." It describes the device, its intended use, and its comparison to a predicate device. However, the provided text does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

Specifically, the document focuses on:

• Introduction and Submitter Information: Standard administrative details.
• Device Name and Classification: Identifying the proprietary and common names, and classification.
• Predicate Device: Stating the device to which substantial equivalence is claimed (Tosoh Medic AIA-Pack HCG Calibration Verification Test Set, K924862).
• Device Description: Explaining that it's a three-level single analyte set of lyophilized, human-based materials assayed in triplicate and compared to target values.
• Intended Use: For quantitative verification of the calibration curve established by Elecsys T Uptake reagents and calibrators on Elecsys 1010 or 2010 immunoassay analyzers.
• Comparison to Predicate: Reaffirming substantial equivalence based on the same intended use.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies, as it is not present in the provided text.

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