(24 days)
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.
§ 862.3555 Lidocaine test system.
(a)
Identification. A lidocaine test system is a device intended to measure lidocaine, an antiarrythmic and anticonvulsant drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of lidocaine overdose or in monitoring levels of lidocaine to ensure appropriate therapy.(b)
Classification. Class II.