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ImmunoCard STAT! HpSA is a rapid in vitro qualitative assay for the detection of Helicobacter pylori antigen (HpSA) in human stool. The stool antigen detection is intended to aid in the diagnosis of H. pylori infection and to demonstrate loss of H. pylori stool antigen following treatment. Conventional medical practice recommends that testing by any method to confirm the loss of antigen be done at least four weeks following completion of therapy.

ImmunoCard STAT! HpSA is a qualitative horizontal flow in vitro diagnostic device used to detect the presence of H. pylori antigen in human stool specimens. The intended use of the device is identical to that of Premier Platinum HpSA (Meridian Bioscience, Inc., Cincinnati, OH) an enzyme-linked immunoassay previously cleared to market under 510(k) K983255. While assay methods differ, both are designed to detect Helicobacter pylori antigen in the stools of patients. The results of both tests are intended to aid in the diagnosis of H. pylori infection and to monitor bacterial reduction in response to anti-bacterial therapy.

Acceptance Criteria and Study for ImmunoCard STAT!® HpSA®

This report describes the acceptance criteria and the study that proves the ImmunoCard STAT! HpSA device meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparative and clinical study results that demonstrate substantial equivalence to the predicate device and acceptable diagnostic accuracy.

2. Sample Sizes Used for the Test Set and Data Provenance

• Comparative Study (with predicate device):

  • Sample Size: 457 total samples.
  • Data Provenance: Not explicitly stated, but implies "in-house" due to the involvement of "four independent laboratories" for initial testing and "a referee laboratory (Meridian Bioscience, Inc., Cincinnati)" for discordant samples. The nature of this study suggests it might be a retrospective assessment of banked samples or a controlled, prospective comparison within the specified labs. Given the device was marketed outside the US since 2002, some of this data may originate from those regions.

• Clinical Studies:

  • Sample Size:
    • Diagnosis (Dyspeptic Patients): 227 consecutive dyspeptic patients.
    • Eradication (Post-Treatment): 85 patients from the initial 227 were followed up post-treatment (22 True Positive, 63 True Negative for H. pylori post-treatment).
  • Data Provenance: Not explicitly stated, but typical for clinical trials involving patient samples. Given the device's prior marketing outside the US since 2002 and references to studies conducted outside the United States (5-9), it is highly probable that this data originates from outside the United States. The text mentions "clinical studies" and "studies conducted outside of the United States."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Comparative Study (with predicate device):

  • Number of Experts: Not specified.
  • Qualifications: The "referee laboratory" (Meridian Bioscience, Inc.) evaluated discordant samples, but the number and specific qualifications of individuals are not detailed. It can be inferred that they were expert laboratory personnel capable of performing thorough investigations and potentially additional confirmatory tests beyond the two assays being compared.

• Clinical Studies:

  • Number of Experts: Not specified.
  • Qualifications: The ground truth for H. pylori infection was established by "conventional in vitro diagnostic methods." These methods involve histology, rapid urease test, and culture, typically interpreted by trained pathologists and microbiologists. While the specific number of experts isn't given, these methods inherently require specialized medical professionals (e.g., pathologists, microbiologists) to establish a diagnosis. The description "histology and urease tests were positive, or if culture was positive" indicates a consensus or composite reference standard approach using widely accepted diagnostic techniques.

4. Adjudication Method for the Test Set

• Comparative Study: An adjudication by a referee laboratory was used for discordant results between the ImmunoCard STAT! HpSA and the Premier Platinum HpSA assays. "Samples giving discordant results...were sent to and evaluated by a referee laboratory" for "further investigation." This suggests a mechanism to resolve discrepancies and arrive at a corrected ground truth or understanding of the discrepancy.

• Clinical Studies: For establishing the H. pylori status of patients, the ground truth was defined as a composite reference standard: "Patients were defined as infected with H. pylori if histology and urease tests were positive, or if culture was positive." This is a form of consensus or composite ground truth rather than a direct adjudication between expert readers of the device. If all three (histology, urease, culture) were performed, two positive results might trigger the positive ground truth, or merely one positive result from any of the three, as implied by the "or if culture was positive" statement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed with human readers and AI assistance. The ImmunoCard STAT! HpSA is a qualitative lateral flow immunoassay with a visual endpoint (pink-red line or no line), interpreted by a laboratory technician. It is not an imaging-based AI device where human readers are typically evaluated with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for ImmunoCard STAT! HpSA. The "Clinical Studies" section provides the standalone diagnostic accuracy (sensitivity, specificity, predictive values, and correlation) of the device against a composite gold standard for H. pylori infection, both for initial diagnosis and for confirming eradication post-treatment. The "Reproducibility," "Assay Specificity," and "Tests for Interfering Substances" sections also represent standalone performance assessments of the device itself.

7. Type of Ground Truth Used

• Comparative Study: The "corrected results" for the comparative study were based on referee laboratory evaluation of discordant samples, which implies further testing or expert review to determine the true status of those samples against the two devices being compared.

• Clinical Studies: The ground truth for H. pylori status was a composite reference standard employing established clinical and laboratory methods:

  • Histology (e.g., biopsy for H&E staining)
  • Rapid Urease Test
  • Bacterial Culture
    Patients were defined as H. pylori positive if histology and urease tests were positive, or if culture was positive. This combines multiple evidence types, often considered a strong form of ground truth in clinical diagnostics.

8. Sample Size for the Training Set

The document does not explicitly state the sample size for a training set. ImmunoCard STAT! HpSA is a qualitative immunoassay, not a machine learning or AI-driven diagnostic device that typically undergoes a distinct "training phase" comparable to algorithms. Its development and validation would involve optimization of reagents and protocols rather than training on a separate dataset in the AI sense.

9. How Ground Truth for the Training Set Was Established

As mentioned above, since this is not an AI/machine learning device, the concept of a "training set" ground truth in the conventional sense does not apply. The development of the assay's capture and detector antibodies and optimizing the assay parameters would be guided by established biological principles and analytical validation using characterized positive and negative controls/samples, rather than a data-driven training set with established ground truth labels for an algorithm.

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