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MAS Diabetes Control is intended for use in the clinical laboratory as an assayed control material suitable for monitoring assay conditions for glycated hemoglobin determinations. Include with patient specimens when assaying for glycated hemoglobin. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

MAS® Diabetes Control Lyophilized Assayed Chemistry Control Level 1 (Normal) and 2 (Abnormal)

I am unable to extract the requested information regarding acceptance criteria, study details, or ground truth for the device from the provided text. The document is an FDA 510(k) clearance letter for the "MAS® Diabetes Control" and primarily focuses on the regulatory determination of substantial equivalence. It does not contain details about specific performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

The document states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...". This indicates that the device was deemed equivalent to an already marketed predicate device, and the specifics of its performance study, if conducted, are not included in this particular regulatory clearance letter.

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