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510(k) Data Aggregation
(58 days)
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) | < 15% (for appropriate technique), as stated for user expectation | From 9.08% to 15.1% for positive sera (Sera #1-5) |
| 121% and 150% for negative sera (Sera #6-7) | ||
| Paired Serum Study (Seroconversion) | 100% agreement expected for evaluable pairs | 100% agreement (for 11 evaluable pairs) |
| Cross-Reactivity | No cross-reactivity with EBV, CMV, VZV | No cross-reactivity observed with tested sera |
| CDC Panel Total Agreement | Performance demonstrated substantial equivalence to predicate device | 96.9% (excluding 2 equivocals) |
| CDC Panel Positive Agreement | Performance demonstrated substantial equivalence to predicate device | 95.7% |
| CDC Panel Negative Agreement | Performance demonstrated substantial equivalence to predicate device | 100% |
2. Sample Sizes Used for the Test Set and Data Provenance
The primary test set for comparison with the predicate device involved sera tested across four different sites.
- Study 1 (Maryland R&D lab): 187 frozen sera (normals aged 12-83, various gender and geographical areas). Retrospective.
- Study 2 (New York R&D lab): 152 frozen sera (normals aged 17-59, various gender and geographical areas). Retrospective.
- Study 3 (Pennsylvania clinical lab): 176 prospective samples sent for Herpes antibody testing. Prospective.
- Study 4 (Wisconsin clinical lab): 88 frozen random normal samples. Retrospective.
- Total Sample Size for Primary Comparison: 603 sera (cumulative across all four studies).
- CDC Panel: A masked, characterized serum panel (details on total number not explicitly stated, but 72% positive and 28% negative samples, with 2 equivocals excluded). The origin is the Centers for Disease Control (CDC), implying a well-characterized and respected source.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This study does not involve human readers interpreting results or establishing ground truth based on expert consensus. The "ground truth" for the comparative studies is the result obtained from the predicate device, the Clark HSV 1 and HSV 2 ELISA assays. For the CDC panel, the "ground truth" is the CDC's characterization of the panel samples. No human experts in the traditional sense (e.g., radiologist) are described as establishing ground truth in this context; instead, the comparator assays serve this role.
4. Adjudication Method for the Test Set
Not applicable. The study compares the new device's results directly against a predicate device. There is no mention of human adjudication for discrepancies between the new device and the predicate device or a clinical outcome.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically done for diagnostic imaging tests or similar assessments where human readers interpret results, and the AI's impact on their performance is evaluated. The device in question is an ELISA kit, which produces quantitative results, not interpretations by human readers in the style of imaging.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies presented are standalone performance evaluations of the Trinity Biotech Herpes Group IgG ELISA kit. The results are generated solely by the device (the assay) and compared against a predicate device or a characterized panel. There is no human "in the loop" impacting the diagnostic output of the device itself.
7. The Type of Ground Truth Used
- For the primary comparison: The predicate device's results (Clark HSV 1 and HSV 2 ELISA assays) served as the "ground truth" or reference standard against which the new device's qualitative agreement (% agreement positive, negative, and total) was measured.
- For the paired serum study: The complement fixation (CF) method was used to determine seroconversion, serving as the ground truth.
- For the cross-reactivity study: The presence of IgG antibodies to specific viruses (EBV, CMV, VZV) was likely determined by established ELISA or other serological methods for those viruses, acting as the ground truth for non-cross-reactivity.
- For the CDC panel: The CDC's characterization of the masked serum panel served as the ground truth.
It is important to note that the document explicitly states: "There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison assay's accuracy to predict disease." This clarifies that the ground truth is primarily based on concordance with another assay, not directly on clinical pathology or patient outcomes.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or AI development. ELISA kits are laboratory tests with defined chemical reactions and optical detection methods; they are not typically "trained" in the way AI models are. The development and optimization of the test kit itself would involve internal studies and reagent validation, but these are distinct from a typical AI training/validation set paradigm.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an algorithm described, this point is not applicable. The development of the ELISA test kit relies on established biochemical principles and validation procedures to ensure the reagents and protocol accurately detect the target antibodies.
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(276 days)
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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