(28 days)
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.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.