(345 days)
The K-ASSAY® Microalbumin reagent is for the quantitative determination of human albumin in urine by immunoturbidimetric assay. Measurement of albumin in urine nids in the diagnosis of kidney dysfunction. FOR IN VITRO DIAGNOSTIC USE.
K-ASSAY ® The Microalbumin Calibrator is for the calibration of the K-ASSAY® Microalbumin assay for quantifying albumin in urine speiment. FOR IN VITRO DIAGNOSTIC USE.
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This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "K-Assay® Microalbumin" and "K-Assay® Microalbumin Calibrator". This type of document typically confirms that a new device is "substantially equivalent" to an already legally marketed device, but it does not specify acceptance criteria or detailed study results.
Therefore, the requested information about acceptance criteria and the study proving the device meets them cannot be extracted from the provided text. The document primarily focuses on regulatory approval and classification rather than performance metrics.
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.