Search Results

The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT- III levels less than 60% of normal are associated with increased risk of thromboembolism. The assay of plasma AT-TII is also helpful in monitoring heparin therapy.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "N-Assay TIA Antithrombin III Test Kit." This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about acceptance criteria or specific study results in the format requested.

Therefore, I cannot provide the requested information from the given text.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size or ground truth establishment for the training set.

The document mainly focuses on the regulatory aspects of the device, its intended use (quantification of human antithrombin III in human plasma, association of low levels with thromboembolism risk, and monitoring heparin therapy), and its classification as substantially equivalent.

Ask a specific question about this device