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For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

The Bayer Special Chemistry Calibrator are for one absolute value of calibrator material prepared in human serum with nonserum constituents added.

All the analytes currently in the calibrator material are: Acid Phosphatase Lactate Pancreatic Amylase Lipase

The intention of this submission is to add the assigned values to the labeling claims for: Pancreatic Amylase Lipase

The provided text describes a 510(k) submission for a Special Chemistry Calibrator and does not contain information about acceptance criteria or a study proving device performance in the context of AI, imaging, or statistical metrics like sensitivity, specificity, or AUC. The document focuses on the regulatory submission for an in vitro diagnostic device and its substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to provide acceptance criteria or a study description as the necessary information is not present in the given text.

Here's why:

• The device is a "Special Chemistry Calibrator," which is a material used to calibrate laboratory instruments. It is not an AI/ML device, an imaging device, or one that would typically have performance evaluated with metrics like those requested (e.g., sensitivity, specificity, AUC).
• The document's purpose is a 510(k) summary, which establishes substantial equivalence to a predicate device based on intended use, material composition, and performance on a specific analytical system. It doesn't typically detail exhaustive performance studies with statistical thresholds for AI or imaging.
• The "Substantial Equivalence" section explicitly states, "The Special Chemistry Calibrators are identical in intended use, storage and handling, stability, source material (human serum), and instructions for use as the previously cleared Special Chemistry Calibrator." The only difference is adding assigned values for two new analytes. This suggests that extensive new performance studies (especially for AI or imaging) would not be required or detailed in this type of submission.

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