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N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and heparinized plasma by means of particle-enhanced immunonephelometry using BN™ Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases.

Polystyrene particles coated with specific antibodies to human cystatin C are aggregated when mixed with samples containing human cystatin C. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

This document is a 510(k) summary for the N Latex Cystatin C device. It describes the device, its intended use, and claims substantial equivalence to a previously marketed device (K003503). However, the provided text does not contain any information regarding specific acceptance criteria, a study proving the device meets these criteria, sample sizes for test or training sets, ground truth establishment methods, or details about expert involvement, adjudication, or MRMC studies.

Therefore, I cannot provide the requested information in the table or the subsequent numbered points based on the input text. The document primarily focuses on regulatory approval and the basic description of the device's mechanism and intended use.

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