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510(k) Data Aggregation
(58 days)
TRINITY BIOTECH, INC.
The Trinity Biotech Captia™ Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.
The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.
The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group 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.
The Trinity Biotech Herpes Group IgG ELISA Test Kit was evaluated for its agreement with predicate devices (Clark HSV 1 and HSV 2 ELISA assays) and for precision, cross-reactivity, and paired serum study performance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in terms of predefined thresholds that the device must meet for approval. Instead, it presents performance characteristics (agreement percentages and precision) observed in comparison to predicate devices and other studies. The approval from the FDA indicates that the device's performance, as demonstrated, was deemed substantially equivalent to existing predicate devices. We can infer that the reported percentages of agreement and precision values were considered acceptable by the regulatory body for demonstrating substantial equivalence.
Based on the cumulative data from the four comparison studies with the predicate device, the key performance metrics are:
| Metric | Acceptance Criteria (Inferred from FDA Approval for Substantial Equivalence) | Reported Device Performance (Cumulative across 4 studies) |
|---|---|---|
| % Agreement Positive | Performance demonstrated substantial equivalence to predicate device | 98.9% (95% CI: 97.9% - 100%) |
| % Agreement Negative | Performance demonstrated substantial equivalence to predicate device | 96.7% (95% CI: 94.2% - 99.1%) |
| % Total Agreement | Performance demonstrated substantial equivalence to predicate device | 98.1% (95% CI: 97.0% - 99.2%) |
| Precision (Intersite CV) |
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(276 days)
TRINITY BIOTECH, INC.
The Trinity Biotech Rotavirus EIA kit is intended for the detection of rotavirus antigen in human fecal specimens and is used as an aid in the diagnosis of acute gastroenteritis caused by rotavirus in children and infants. The performance characteristic was not determined in the elderly population.
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I cannot fulfill this request. The provided text is a regulatory document from the FDA regarding a medical device, the "Trinity Biotech's Rotavirus EIA". It is a clearance letter for a 510(k) submission and discusses substantial equivalence, regulatory classifications, and general controls.
The document does not contain any information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria (beyond stating that the device is substantially equivalent to a predicate).
- Sample sizes for test sets or training sets.
- Data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth details.
Therefore, I cannot extract the requested information as it is not present in the provided text.
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