(277 days)
The ImmunoCard H. pylori enzyme immunoassay (EIA) is an in vitro qualitative procedure for the detection of IgG to Helicobacter pylori in human serum, plasma and whole blood. Test results are intended to aid in the diagnosis of H. pylori infection. ImmunoCard H. pylori may be performed by clinical laboratories or in physician's offices.
The ImmunoCard H. pylori assay system is a membrane based EIA for detecting IgG to H. pylori in human serum and plasma. Each kit contains the following components: H. pylori Test Cards (30), Enzyme Conjugate (5ml), Wash Buffer (15ml), Substrate Reagent (15ml), Positive Control (2ml), Neqative Control (2ml), Whole Blood Sample Diluent (6.5ml), Heparinized Capillary Tubes (30), Transfer Pipets (30).
Here's an analysis of the provided text regarding the ImmunoCard H. pylori device, outlining acceptance criteria and supporting study details:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Relative Agreement | 99.1 + 1.8% (107/108) |
Study Details
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Sample Size used for the test set and data provenance:
- Sample Size: 108 (n=108)
- Data Provenance: Not explicitly stated regarding country of origin. The study compares a new device to an existing one, which implies the data could be retrospective from past testing or prospective, but this is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" in this context is the performance of a predicate device (ImmunoCard Helicobacter pylori Whole Blood Assay), not an expert interpretation of a diagnostic sample.
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Adjudication method for the test set: Not applicable. The study's "ground truth" is a comparison against a predicate device's result. There is no mention of adjudication among multiple readers or experts.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes an in vitro diagnostic (IVD) device, not an AI system. Therefore, MRMC studies and human reader improvement with AI are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the device itself provides a standalone result without human interpretation of a complex image or data. The human interaction is limited to performing the assay and observing a color change. The performance metrics presented (relative agreement) reflect this standalone device performance.
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The type of ground truth used: The "ground truth" for this study is the result obtained from the predicate device, ImmunoCard Helicobacter pylori Whole Blood Assay. The new device's performance is measured in terms of agreement with this established device.
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The sample size for the training set: Not applicable. This diagnostic device is likely based on immunological reactions, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established: Not applicable, as there is no training set in the context of this type of diagnostic device.
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).