(27 days)
Liquid Human Glycosylated Hemoglobin (A1C) Control is intended for use in the laboratory to monitor the precission and accuracy of Glycosylated Hemoglobin (A1C) assay procedures for the methods listed in the package insert. The routine use of quality control materials is an integral part of ensuring the accuracy and precision of laboratory analyses.
Not Found
The provided text is a government letter concerning the substantial equivalence determination for a medical device called "Glycosylated Hemoglobin A1C Control Normal and Elevated." It informs the manufacturer that they can market the device.
However, the document does not contain any information about acceptance criteria, device performance, a specific study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The letter is solely an administrative notification of regulatory clearance.
Therefore, I cannot provide the requested table and study details based on the input text.
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.