Search Results

Abbott Immunoassay-MCC (Liquid) Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Abbott Immunoassay-MCC (Liquid) Control." This letter states that the device has been determined to be substantially equivalent to a legally marketed predicate device.

However, the document does NOT contain the detailed information necessary to answer the questions about acceptance criteria, device performance, study design, expert qualifications, or ground truth establishment.

The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed report of a new prospective clinical study with specific acceptance criteria and performance metrics. The letter confirms the device's clearance for marketing based on its intended use as an assayed quality control serum.

Therefore, I cannot extract the requested information from the provided text. To answer these questions, I would need access to the original 510(k) submission document or related study reports that would have been submitted to the FDA for review.

Ask a specific question about this device