(19 days)
The N-Acetylprocainamide (NAPA) Enzyme Immunoassay is intended for in vitro diagnostic use for quantitative determination of N-acetylprocainamide in human serum or plasma. NAPA is the major metabolite of procainamide. Its pharmacologic activity is almost equal to that of procainamide. Furthermore, serum NAPA concentration may exceed its parent drug concentration. Therefore, simultaneous measurement of procainamide and NAPA serum concentration is critical in achieving optimal procainamide therapy.
Not Found
The provided text is an FDA 510(k) clearance letter for an in vitro diagnostic device, the N-Acetylprocainamide (NAPA) Enzyme Immunoassay. This letter primarily focuses on the regulatory clearance process, stating that the device has been found substantially equivalent to legally marketed predicate devices.
However, the document does NOT contain information about:
- Specific acceptance criteria used in a performance study.
- The results of such a study (device performance data).
- Any details regarding sample sizes (test or training sets).
- Data provenance.
- The number or qualifications of experts involved in establishing ground truth.
- Adjudication methods.
- Comparative effectiveness studies (MRMC).
- Standalone algorithm performance.
- The type of ground truth used or how ground truth for training data was established.
Therefore, I cannot provide the requested table or answer the specific questions based on the provided text. The document is strictly a regulatory clearance letter and does not delve into the technical study details that would typically be found in a 510(k) summary or the full submission.
§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.