(91 days)
The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer.
The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.
The method for qualitative determination of IgG antibodies to Helicobacter pylori (H.pv/ori IgG) is a two-step, indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Helicobacter pylori antigen and a conjugate of anti-human IgG monoclonal antibodies to linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, H. pylori antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjugate reacts with H. pylori lgG that is already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle.
Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of H. pylori IgG in calibrators, samples or controls.
All assay steps and incubations are performed by the LIAISON® XL Analyzer.
The provided text describes a 510(k) premarket notification for the "LIAISON® H. pylori IgG" assay, an in vitro diagnostic device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device (Siemens IMMULITE 2000 H. pylori IgG Assay).
Here's an analysis of the acceptance criteria and study data based on the provided text, using the requested framework:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, it presents performance data for comparison against a predicate device. The implied acceptance criteria are that the new device's performance (specifically, accuracy as measured by percent agreement) is comparable to that of the predicate device within acceptable statistical variation.
Here's a table summarizing the reported device performance, which serves as evidence of meeting the implied acceptance criteria for equivalence:
Table 1: Device Performance (Comparative Clinical Study)
| Performance Metric | Acceptance Criteria (Implied: Comparable to Predicate) | Reported Device Performance (LIAISON® H. pylori IgG) |
|---|---|---|
| Negative Percent Agreement | High agreement with predicate device (e.g., >90-95%) | 99.2% (95% CI: 97.9 – 99.8%) |
| Positive Percent Agreement | High agreement with predicate device (e.g., >90-95%) | 95.5% (95% CI: 90.4 – 98.4%) |
Note: The document also includes extensive precision/reproducibility data (Within-Laboratory Precision and Reproducibility at multiple sites), which are crucial for establishing the reliability and consistency of the assay. While not direct "acceptance criteria" in terms of accuracy against a true disease state, these data demonstrate the device's analytical performance meets expected standards for an in vitro diagnostic.
Study Details
Here's a breakdown of the specific information requested, based on the provided text:
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 504 samples
- Data Provenance:
- Country of Origin: Multiple geographical locations in the U.S.
- Retrospective or Prospective: Prospective study. Samples were collected from non-selected adult subjects sent to the laboratory for H. pylori IgG serological testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not Applicable / Not Provided: For this type of in vitro diagnostic device (immunoassay for antibodies), the "ground truth" for the comparative clinical study is established by the results of a legally marketed predicate device, not by expert interpretation of images or other clinical data. Hence, there is no mention of experts establishing a ground truth in the context of radiologists or similar clinical reviewers.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided: Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (e.g., image reading) where there might be disagreement. In this comparative study with a predicate device, the comparison is directly between the new device's results and the predicate device's results, with no mention of human adjudication of results. The "ground truth" is effectively the predicate device's result.
5. 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:
- No: An MRMC comparative effectiveness study is not applicable as this is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. The device performs the test autonomously.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes: This device (LIAISON® H. pylori IgG assay) is inherently a standalone diagnostic test. Its performance is evaluated based on its ability to detect antibodies independently. The clinical study compares its standalone performance against another standalone device (the predicate).
7. The Type of Ground Truth Used:
- Predicate Device Results: For the comparative clinical study, the "ground truth" against which the LIAISON® H. pylori IgG assay was evaluated was the results from the FDA-cleared predicate device (Siemens IMMULITE 2000 H. pylori IgG Assay).
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided: This is an immunoassay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The development of reagents and assay parameters is based on biochemical and analytical principles, not on training data in the way an AI model would be.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable / Not Provided: As noted above, there is no "training set" in this context. The assay's performance characteristics (e.g., cutoff values) are established through analytical validation and optimization, often against known positive and negative samples, but not through a "ground truth" establishment process for a training set as would be done for an AI algorithm.
§ 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).