(58 days)
The Trinity Biotech Captia™ Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for seroconversions and the presence of a significant increase in specific IgG as and aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population.
The Mycoplasma IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for semi-quantitative or qualitative determination of IgG antibodies in human serum to Mycoplasma pneumoniae for the determination of immunological experience. The Mycoplasma IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions and a significant increase in specific IgG as an aid in the diagnosis of Mycoplasma pneumoniae infection in the adult population. For In Vitro Diagnostic Use Only.
The Mycoplasma IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Mycoplasma pneumoniae. Purified Mycoplasma pneumoniae antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing and indirect measurement of specific antibody in the patient specimen.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Agreement with Predicate Device (IFA) | ||
| % Agreement Positive (Study 1) | High positive agreement (e.g., >90%) | 95.1% (95% CI: 91.2% - 99.0%) |
| % Agreement Negative (Study 1) | Sufficient negative agreement (no explicit target, but acceptable for predicate comparison) | 55.6% (95% CI: 40.7% - 70.4%) |
| % Overall Agreement (Study 1) | High overall agreement (e.g., >80%) | 84.5% (95% CI: 78.1% - 90.1%) |
| % Agreement Positive (Study 2) | High positive agreement (e.g., >90%) | 98.5% (95% CI: 96.4% - 100.0%) |
| % Agreement Negative (Study 2) | Sufficient negative agreement (no explicit target, but acceptable for predicate comparison) | 45.9% (95% CI: 29.6% - 62.3%) |
| % Overall Agreement (Study 2) | High overall agreement (e.g., >80%) | 87.1% (95% CI: 82.0% - 92.3%) |
| Precision (CV) | 46% rise in ISR value when acute sera 46% rise) | |
| CF Paired Serum Study (% rise in ISR value) | > 46% rise in ISR value for serum meeting paired sera criteria, leading to 100% agreement positive. | 100% agreement positive (7/7 pairs showed > 46% rise) |
| Reproducibility (Pearson correlation coefficient) | > 0.987 (between sites) | > 0.987 |
| Reproducibility (% agreement of expected results) | High agreement (e.g., >95%) | 99.3% (145/146) |
Note on Acceptance Criteria: The document primarily presents performance characteristics and compares them to a predicate device or implied standards (e.g., "With appropriate technique the user should obtain precision of
§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”