(66 days)
Fructosamine: The Randox Laboratories Limited Fructosamine test kit is an in vitro diagnostic enzymatic assay for the quantitative determination of glycated protein (fructosamine) in human serum or plasma. Measurement of glycated serum protein is representative of the mean blood glucose levels over the preceding 2-3 weeks. For in vitro diagnostic use only. Fructosamine Calibrator: For calibration of the Fructosamine assay. For in vitro diagnostic use only. Fructosamine Controls (Level 1 and Level 3): To monitor the performance of the Fructosamine assay. For in vitro diagnostic use only.
Not Found
I am sorry, but the provided text from the FDA 510(k) summary does not contain the detailed information necessary to complete the requested table and answer the study-related questions. The document primarily focuses on the substantial equivalence determination for the Fructosamine device. It does not include:
- Acceptance criteria specified with numerical targets.
- Detailed device performance data (e.g., accuracy, precision, sensitivity, specificity).
- Information about specific studies conducted (e.g., sample sizes for test/training sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies).
Therefore, I cannot extract the information required to fulfill your request based on the given text.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).