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The K-ASSAY Apo B Assay is intended to be used for the quantitative determination of Apo B in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and related diseases. FOR IN VITRO DIAGNOSTIC USE.

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The provided text is a 510(k) clearance letter from the FDA for a device named "K-ASSAY Apo B." This document primarily grants substantial equivalence and does not contain detailed information about acceptance criteria or specific study results that prove the device meets those criteria. Such detailed information is typically found in the 510(k) summary, which is a separate document.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

• No Acceptance Criteria: The document does not specify any performance-based acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
• No Reported Device Performance: While the device is cleared for "quantitative determination of Apo B," the document does not contain numerical performance data such as assay precision, accuracy, linearity, or comparison with a reference method.
• No Study Details: There is no mention of the type of study conducted (e.g., prospective, retrospective), sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
• No Ground Truth Information: The document does not describe how ground truth was established for development or testing sets.

The core of this document is the FDA's regulatory decision, not a scientific report of a device's performance characteristics.

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