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This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low level albumin in human Urine. It is intended for in vitro diagnostic use only. Microalbumin has been reported in several studies to predict development of diabetic nephropathy and its mortality risk. Measurement of urine albumin is a useful indicator of early glomerular disease.

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I am sorry, but the provided text does not contain the detailed information necessary to complete the acceptance criteria table and the study description as requested. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not typically include the detailed performance study results, sample sizes, ground truth establishment methods, or expert qualifications that would be present in a submission for acceptance criteria.

The information I can extract is limited to:

• Device Name: Microalbumin
• Intended Use: Quantitative determination of low-level albumin in human urine, for in vitro diagnostic use in a diagnostic laboratory setting by qualified laboratory technologists. It is indicated as a useful indicator of early glomerular disease and to predict the development of diabetic nephropathy and its mortality risk.
• Regulatory Class: Class II
• Product Code: DDZ; JIT

To fulfill your request, I would need a different type of document, such as a summary of safety and effectiveness data (SSE) or the full 510(k) submission, which often includes details of the performance studies.

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