(280 days)
The intended use of Express-Med's A1c-EXPRESS is for the determination of percent of hemoglobin A1c in human whole blood samples. Clinically, Express-Med's A1c-EXPRESS is intended to be used as a measure of longterm glycemic control in patients with diabetes mellitus. This product will be available to patients through Point of Care offices.
Preferably, A1c-EXPRESS should be used in conjunction with other diabetes management tools, including consultation with health care professionals, goal-setting, education, exercise, diet, and, when prescribed, medication.
A1c-EXPRESS does not replace daily blood glucose monitoring.
There are no known contraindications.
The kit should be kept out of reach of children.
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This document is a 510(k) clearance letter for the A1c-EXPRESS Hemoglobin A1c Sample Collection Kit. As such, it does not contain the detailed study information or acceptance criteria typically found in a clinical study report or a premarket approval (PMA) application. A 510(k) demonstrates substantial equivalence to a predicate device, not necessarily independent clinical performance criteria with a new study.
Therefore, I cannot provide the requested information based solely on the provided text. The document refers to "indications for use" and that the device is "substantially equivalent" to previously marketed devices, but does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
To obtain this information, one would typically need to refer to the original 510(k) summary or submission documents, which are usually more detailed than the clearance letter itself.
§ 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).