(136 days)
The West Nile Detect IgM Capture ELISA is for the qualitative detection of IgM antibodies to WNV recombinant antigens (WNRA) in serum for the presumptive clinical laboratory diagnosis of West Nile virus infection in patients with clinical symptoms consistent with meningoencephalitis. Positive results must be confirmed by Plaque Reduction Neutralization Test (PRNT), or by using the current CDC guidelines for diagnosis of this disease. Assay performance characteristics have not been established for testing cord blood, neonate, prenatal screening, general population screening without symptoms, or automated instruments. This assay is not FDA cleared or approved for testing blood or plasma donors.
West Nile Detect IgM Capture ELISA
I am sorry, but the provided text from the FDA 510(k) letter for the "West Nile Detect IgM Capture ELISA" device does not contain the specific information requested to describe the acceptance criteria and the study that proves the device meets those criteria, and therefore, I cannot fulfill your request to create the tables and sections you've outlined.
The document is a clearance letter indicating that the FDA found the device substantially equivalent to a predicate device. It defines the "Indications For Use" and general regulatory requirements but does not detail the performance study, acceptance criteria, or the specific results of such a study.
Specifically, the following information is missing from the provided text:
- Table of acceptance criteria and reported device performance: This information would typically be in the 510(k) submission's performance data section, not the clearance letter.
- Sample sizes used for the test set and data provenance: No details on the test set or its origin.
- Number of experts and their qualifications for ground truth: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No mention of such a study or any effect size.
- Standalone (algorithm-only) performance: This is an ELISA kit, not an algorithm in the typical sense for standalone performance.
- Type of ground truth used: While "presumptive clinical diagnosis" and "Plaque Reduction Neutralization Test (PRNT)" are mentioned as confirmation for positive results, the specifics of how the ground truth for the study was established are not provided.
- Sample size for the training set: Not applicable for an ELISA kit in the same way it would be for an AI algorithm, and in any case, not provided.
- How ground truth for the training set was established: Not applicable/not provided.
To obtain this information, one would typically need to consult the full 510(k) submission document, which often contains detailed study protocols and results, or scientific publications related to the validation of this specific assay. The provided FDA clearance letter is a summary of the regulatory outcome, not the detailed technical data.
§ 866.3940 West Nile virus serological reagents.
(a)
Identification. West Nile virus serological reagents are devices that consist of antigens and antisera for the detection of anti-West Nile virus IgM antibodies, in human serum, from individuals who have signs and symptoms consistent with viral meningitis/encephalitis. The detection aids in the clinical laboratory diagnosis of viral meningitis/encephalitis caused by West Nile virus.(b)
Classification. Class II (special controls). The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Serological Reagents for the Laboratory Diagnosis of West Nile Virus.” See § 866.1(e) for the availability of this guidance document.