Search Results

For the quantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain liver and heart diseases.

AST/SGOT LIQUID REAGENT - KINETIC METHOD

The provided document is a 510(k) clearance letter from the FDA for an AST/SGOT Liquid Reagent - Kinetic Method device. This type of document does not typically contain the detailed study information or acceptance criteria as outlined in your request for AI/diagnostic imaging devices.

The 510(k) clearance process demonstrates substantial equivalence to a predicate device, rather than requiring extensive clinical trials with specific performance metrics and acceptance criteria in the same way newer, high-risk devices or AI-driven diagnostics do.

Therefore, I cannot extract the specific information you've requested from these pages. The document confirms:

• Device Name: AST/SGOT LIQUID REAGENT - KINETIC METHOD
• Intended Use: "For the quantitative determination of Aspartate Aminotransferase (AST) in serum. Aspartate Aminotransferase determination is use for the diagnosis of certain liver and heart diseases."

To answer your questions about acceptance criteria and study data, one would typically need access to the 510(k) submission document itself, which would include performance data from the manufacturer's internal studies comparing their device to the predicate. This information is not present in the FDA's clearance letter.

Ask a specific question about this device