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The Beckman Coulter Drug Calibrator 2 is a six-level calibrator intended for use on the SYNCHRON CX Systems and LX20 Systems for the calibration of digoxin and acetaminophen.

The SYNCHRON® Systems Drug Calibrator 2 is intended for use on SYNCHRON Systems for the calibration of digoxin and acetaminophen. This product contains a 2.0 mL bottle each of Levels 1 to 6 of Drug Calibrator 2. The storage temperature for the calibrator is +2℃ to +8℃.

The provided text is a summary of safety and effectiveness for a medical device (SYNCHRON® Systems Drug Calibrator 2) submitted to the FDA. It does not contain detailed information about acceptance criteria or a study proving the device meets those criteria.

Instead, the document focuses on:

• Identification of the device and manufacturer.
• Intended use of the device: Calibration of digoxin and acetaminophen on SYNCHRON CX Systems and LX20 Systems.
• Comparison to a predicate device: Highlighting that the digoxin level is identical and both use human serum with weighed-in quantities of digoxin. The main difference noted is the new product contains acetaminophen analyte.
• Regulatory information: Classification, predicate device, and the FDA's letter of substantial equivalence.

Therefore, I cannot provide the requested information about acceptance criteria and a study from the given text. There are no tables of acceptance criteria, reported device performance data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance details, or information about training sets or ground truth establishment.

The "Summary of Performance Data" section is extremely brief and only states, "The new Drug Calibrator 2 product contains acetaminophen analyte." This is not a summary of performance data in the context of meeting acceptance criteria.

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