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Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide Calibrator, are intended for the quantitative determination of carbon dioxide (CO2) in serum and plasma. Diazyme Carbon Dioxide Enzymatic Assay Kit contains a single-point calibrator. The calibrator, along with 0.9% saline as a zero reference, is used to generate a linear graph that will be used in the calculation of carbon dioxide concentrations in unknown samples. Diazyme Carbon Dioxide Control Set has controls for normal carbon dioxide level and abnormal carbon dioxide level. The controls are used as reference samples for checking the functionality of the Diazyme Carbon Dioxide Enzymatic Assay.

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I am unable to find the acceptance criteria or results of a study that proves the device meets acceptance criteria in the provided document. The document primarily contains a 510(k) summary, an FDA clearance letter, and an "Indications for Use" statement for the Diazyme Carbon Dioxide Enzymatic Assay Kit.

This type of document typically focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the way described in your request. While it mentions the calibrator and controls, it does not provide:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test sets, data provenance, or ground truth establishment.
• Details on expert involvement, adjudication methods, or MRMC studies.
• Information regarding standalone algorithm performance, training set size, or training ground truth.

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