(60 days)
The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in fingerstick capillary and venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus.
The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.
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This document is a 510(k) clearance letter from the FDA for the PixoTest POCT System for measuring glycated hemoglobin (HbA1c). However, it does not contain the specific acceptance criteria, detailed study results, or information about the sample size, ground truth establishment, expert qualifications, or adjudication methods for the performance studies.
The letter confirms the device's clearance and its intended use: "quantitative measurement of glycated hemoglobin (%HbA1c) in fingerstick capillary and venous whole blood samples... intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus."
To provide the requested information, you would need access to the full 510(k) premarket notification submission (K192369) itself, which typically includes detailed performance data from validation studies. This clearance letter only states that the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance meets established standards, but does not explicitly list those standards or the specific data showing compliance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text. The document refers to the "enclosure" for the indications for use but does not include the detailed performance data that would answer your questions.
§ 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).