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The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is a qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved human fecal specimens. This test is indicated as an aid in the clinical laboratory diagnosis of suspected Giardia infections. For in vitro diagnostic use.

The IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit is an immunochromatographic assay for the detection of Giardia lamblia antigen in human fecal samples. The test uses sample wicking to capture Giardia antigen on a discrete test line containing antibodies specific for Giardia antigen. A specimen is added to a dilution tube and mixed with a buffer solution. The mixture is dispensed into the sample well of the device which resolubilizes the Giardia specific mouse monoclonal antibody that has been conjugated to colored microparticles. This solution wicks along a membrane containing capture antibodies bound to the membrane at the Test and Control lines. The Giardia immune complex, if present, reacts with antibody at the Test line. Unbound conjugate not captured at the test line is captured at the Control line containing anti-mouse antibody. If Giardia antigens are present in the fecal sample, two pink-to-purple bands (one at the Sample line and one at the Control line) will appear in the test window. If no Giardia antigen is present, or if the level of antigen is below the detection limit of the assay, only one pink-to-purple band at the Control line will appear in the test window. For the test to be valid, a pink-to-purple band must always appear at the Control line position of the device test window regardless of whether the sample is positive or negative. This Control line indicates that the test is working properly.

Acceptance Criteria and Study for IVD Research, Inc. Giardia Fecal Antigen Detection Lateral Flow Kit

This response will detail the acceptance criteria and the study performance for the Giardia Fecal Antigen Detection Lateral Flow Kit, as extracted from the provided 510(k) Pre-market Notification.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity and specificity. Instead, the "acceptance" is implied through a comparison to a predicate device and a reference method, aiming for "substantial equivalence" and acceptable clinical performance.

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

• Clinical Performance Study:
  • Sample Size: A total of 210 human fecal specimens were used.
  • Data Provenance: Retrospective. The samples were "well-characterized, archived samples" collected in 10% formalin or SAF. They were submitted to an independent laboratory for testing. The country of origin is not specified but is implicitly the US given the FDA submission.
• Unpreserved Fecal Specimens Study:
  • Sample Size: 42 unpreserved fecal samples (15 positive, 27 negative)
  • Data Provenance: Retrospective. These samples were from IVD Research's frozen sample bank, stored at -15℃ or lower. The country of origin is implicitly the US.
• Reproducibility Study:
  • Sample Size: A masked panel of ten samples (number of positive/negative not specified, but 6 positive and 4 negative in the summary table). These were tested repeatedly.
  • Data Provenance: Not explicitly stated, but performed at three sites (one internal, two external), suggesting a multi-center study, likely within the US.
• Predicate Device Comparison Study:
  • Sample Size: Total of 110 samples (49 positive by predicate, 61 negative by predicate).
  • Data Provenance: Not explicitly stated, but implies existing samples were used for comparison.

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

• Clinical Performance Study (Reference Method: Microscopy or Direct Immunofluorescence Assay): The document does not specify the number of experts or their qualifications for establishing the ground truth using microscopy or direct immunofluorescence assay. It states that the specimens were "submitted to an independent laboratory for testing," implying expertise within that laboratory. For the 4 false positives, these were "re-tested using a direct immunofluorescence assay and shown to be positive," suggesting a re-evaluation by an expert or a highly sensitive method.
• Unpreserved Fecal Specimens Study (Reference Method: Giardia lamblia Antigen Detection Microwell ELISA): The ground truth was established by another IVD Research, Inc. product, the Giardia lamblia Antigen Detection Microwell ELISA. No human experts are explicitly mentioned for this ground truth establishment, as it is an automated assay.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for reconciling discrepancies for the primary clinical performance test set. For the "false positive" samples identified with the Giardia LF test (4 cases), they were "re-tested using a direct immunofluorescence assay and shown to be positive," which implies a secondary, definitive reference method was used to adjudicate these discrepancies and re-classify them as true positives. For the comparison with the predicate device, the agreement was calculated directly, without mention of an adjudication process for discordant results.

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

No MRMC comparative effectiveness study was mentioned. The device is a Lateral Flow Kit, which generally involves visual interpretation by a single user, not an AI or human reader improvement scenario.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The device is a Lateral Flow Kit, which is a diagnostic assay that provides a visual result (bands) requiring human interpretation, not an algorithm running independently.

7. Type of Ground Truth Used for Clinical Performance

• Clinical Performance Study: The ground truth was established by "Microscopy or Direct Immunofluorescence Assay." This represents an expert-determined or highly sensitive laboratory reference method, likely considered the gold standard for clinical diagnosis of Giardia at the time.
• Unpreserved Fecal Specimens Study: The ground truth was established by a Giardia lamblia Antigen Detection Microwell ELISA (IVD Research, Inc.). This is a laboratory assay serving as the reference.

8. Sample Size for the Training Set

The document does not provide information about a "training set" in the context of an algorithm or machine learning model. The studies described are performance evaluations of the completed device. For IVD diagnostic kits, development typically involves internal analytical studies and optimization, rather than a distinct "training set" as understood in AI/ML.

9. How the Ground Truth for the Training Set Was Established

As there is no explicit mention of a "training set" or a machine learning algorithm, this question is not applicable to the provided information.

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