Search Results

This homogeneous lidocaine enzyme immunoassay is intended to be used for quantitative determination of lidocaine in human serum or plasma. Monitoring serum or plasma lidocaine concentration is the most effective means of improving the drug efficacy and minimizing the risk of toxicity for patients under lidocaine treatment for certain cardiac arrhythmias.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a Lidocaine Enzyme Immunoassay. It determines the device is substantially equivalent to previously marketed devices. However, it does not contain specific details about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

Such information would typically be found in the 510(k) submission itself, or in supplementary documents that describe the studies conducted to demonstrate substantial equivalence. The clearance letter only states that the FDA reviewed the submission and determined substantial equivalence based on the indications for use.

Therefore, I cannot provide the requested information from the given text. A 510(k) clearance letter acknowledges the review and decision, but does not usually include the detailed study results or acceptance criteria.

Ask a specific question about this device