(113 days)
The Zeus Scientific, Inc AtheNA Multi-Lyte Borrelia VISE-1/ pepC10 Plus Test System is a multiplexed sandwich immunoassay for the qualitative detection of IgG class antibody to recombinant VISE-1 and the IgM class of antibody to synthetic pepC10 in human serum. The AtheNA Multi-lyte Borrelia VISE-1/pepC10 Plus Test System is intended for use with the Luminex® 200 IS and the AtheNA Multi-Lyte data management package in testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive specimens should be tested with a second-tier test such as Western Blot which if positive, is supportive evidence of infection with B.burgdorferi. Diagnosis of Borreliosis should be made based on the presence of 8.burgdorferi antibodies, history, symptoms and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis.
The AtheNA Multi-Lyte Borrelia VlsE-1/pepC10 Plus Test System is a micro particle immunoassay intended for the qualitative detection of distinct IgG class antibody to VlsE-1 and distinct IgM antibody to pepC10. The assay is a multiplexed immunoassay designed to simultaneously detect, distinguish and identify IgG reactivity to recombinant VISE-1 antigen and IgM reactivity to synthetic pepC10 antigen. The test system is comprised of the AtheNA Multi-Lyte test kit and the Luminex Corp instrument model number Luminex™ 200 IS and software version 3.
Here's an analysis of the acceptance criteria and the studies performed for the Zeus Scientific Inc. AtheNA Multi-Lyte Borrelia VlsE-1/pepC10 Plus Test System, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not explicitly state "acceptance criteria" in the format of a predefined performance target, but rather presents the results of various validation studies, which imply what would be considered acceptable performance for a diagnostic device in its class. For the purpose of this analysis, I will infer relevant performance metrics from the study results.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric Category | Implied Acceptance Criteria (Inferred from context and typical IVD requirements) | Reported Device Performance (AtheNA Multi-Lyte Borrelia VlsE-1/pepC10 Plus Test System) | Relevant Section(s) |
|---|---|---|---|
| Linearity (R-squared) | R-squared value ≥ 0.90 | Demonstrated dilutions recovered within acceptance criteria (implies R-squared ≥ 0.90) | 7A: Linearity |
| Analytical Specificity (Interfering Substances - Signal Change) | Signal change 85%) | 100% (21/21) (95% CI: 86.7%-100%) | Table 1 (Study 1) |
| Performance with Characterized Convalescent Samples (Agreement with Clinical Diagnosis) | High agreement (e.g., >85%) | 94% (47/50) (95% CI: 83.5%-98.8%) | Table 1 (Study 1) |
| Performance with Culture Positive Early Acute Samples (Agreement with Clinical Diagnosis) | Moderate agreement given early stage (no explicit target, but a clear improvement over random) | 51.9% (41/79) (95% CI: 40.4%-63.3%) | Table 1 (Study 1) |
| Performance with Early Convalescent Samples (Agreement with Clinical Diagnosis) | High agreement (e.g., >70%) | 78.5% (62/79) (95% CI: 67.8%-86.9%) | Table 1 (Study 1) |
| Overall Performance with Characterized Samples (Agreement with Clinical Diagnosis) | High overall agreement | 74.7% (171/229) (95% CI: 68.5%-80.2%) | Table 1 (Study 1) |
| Prospective Study (Positive Percent Agreement - PPA) | High PPA compared to predicate ELISA (no explicit target, but expectation is substantial equivalence) | 81.4% (162/199) (95% CI: 75.3-86.6) | Table 2 (Study 2) |
| Prospective Study (Negative Percent Agreement - NPA) | High NPA compared to predicate ELISA (no explicit target) | 91.4% (509/557) (95% CI: 88.7-93.6) | Table 2 (Study 2) |
| Retrospective Study (PPA) | High PPA compared to predicate ELISA | 80% (180/225) (95% CI: 74.2-85.0) | Table 3 (Study 3) |
| Reproducibility (Total %CV) | Acceptable coefficient of variation (typically |
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).