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The SYNCHRON® CX Systems Prealbumin Calibrator, used in conjunction with SYNCHRON® Systems Prealbumin reagent, is intended for use on Beckman's SYNCHRON CX Systems for the calibration of prealbumin test systems.

The SYNCHRON CX Systems Prealbumin Calibrator Set is a six level ready-to-use human serum-based liquid calibrator set manufactured by Beckman Coulter, Inc. Each kit contains 1 X 3 mL bottles of a specific level of calibrator (identified as Levels 1 to Level 6).

Here's an analysis of the provided text regarding the acceptance criteria and study for the SYNCHRON® CX Systems Prealbumin Calibrator:

Acceptance Criteria and Device Performance

The provided document does not explicitly state specific numerical acceptance criteria for the SYNCHRON® CX Systems Prealbumin Calibrator. Instead, the primary basis for acceptance is a finding of "substantial equivalence" to a legally marketed predicate device.

The "Summary of Performance Data" states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution."

The comparison to the predicate device focuses on characteristics rather than quantitative performance metrics. While the document doesn't list specific performance criteria with numerical targets (e.g., accuracy within X%, precision with CV

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