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The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples taken from patients suspected of having respiratory tract infection attributable to Bordetella pertussis.

The illumigene Pertussis DNA Amplification Assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to pertussis by targeting the IS481 insertional element of the B. pertussis genome. The 18481 insertional element can also be found in B. holmesii and some B. bronchiseptica strains. Respiratory infections with B. pertussis, B. holmesii or B. bronchiseptica may yield positive test results infection may cause clinical illness similar to B. pertussis, and mixed outbreaks involving both B. pertussis and B. holmesii infection have been reported. Additional testing should be performed if necessary to differentiate B. holmesii and B. pertussis. B. bronchiseptica is a rare cause of infection in humans. When clinical factors suggest that B. pertussis may not be the cause of respiratory infection, other clinically appropriate investigation(s) should be carried out in accordance with published guidelines.

Negative results for the illumigene Pertussis DNA Amplification Assay do not precude Bordetella pertussis infection and positive results do not rule out co-infection with other respiratory pathogens. Results from the illumigene Pertussis assay should be used in conjunction with information obtained during the patient's clinical evaluation as an aid in diagnosis of B. pertussis infection and should not be used as the sole basis for treatment or other patient management decisions.

illumigene Pertussis DNA Amplification Assay is intended for use in hospital, reference or state laboratory settings. The device is point-of-care use.

The illumigene Pertussis DNA Amplification Assay, performed on the illumipro-10™, is a qualitative in vitro diagnostic test for the direct detection of Bordetella pertussis in human nasopharyngeal swab samples. The assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to target the IS481 insertional element of the B. pertussis genome.

Here's an analysis of the provided text regarding the illumigene Pertussis DNA Amplification Assay, structured to answer your questions about acceptance criteria and the supporting study:

The provided document is an FDA 510(k) clearance letter for the illumigene Pertussis DNA Amplification Assay. It primarily outlines the device's intended use and FDA's determination of substantial equivalence. Crucially, this document does NOT contain detailed information about the acceptance criteria or the specific study results proving the device meets those criteria.

Generally, for an in vitro diagnostic (IVD) like this, acceptance criteria would involve performance metrics such as sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) compared to a reference standard. The study data would then quantify these metrics.

Since the provided text does not contain this information, I will indicate where the information is not provided by the document.

Acceptance Criteria and Study Details for illumigene Pertussis DNA Amplification Assay

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not provided in this document.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in this document. Typically, clinical studies for IVDs involve prospective collection of samples from diverse geographic locations to ensure generalizability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is typically relevant for image-based diagnostic devices or those requiring expert interpretation. For a DNA amplification assay, the "ground truth" for the test set is established by a reference method (e.g., culture, another highly sensitive PCR method with sequencing confirmation). Therefore, the concept of "experts establishing ground truth" in the same way it would apply to imaging interpretation is not directly applicable here.

• Number of experts: Not applicable in the context of this type of diagnostic test's ground truth.
• Qualifications of experts: Not applicable.

4. Adjudication method for the test set

As the ground truth for a DNA amplification assay is typically established through laboratory reference methods (e.g., bacterial culture, validated PCR with sequencing), an "adjudication method" involving human readers (like 2+1, 3+1 for imaging) is not applicable. Discrepancies would be resolved by retesting or using a higher-level confirmatory test.

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

• MRMC Study: No, an MRMC study is not applicable for a standalone in vitro diagnostic (IVD) test like a DNA amplification assay. This type of study is designed for diagnostic tools that involve human interpretation, such as medical imaging analysis, often comparing AI-assisted performance against unassisted human performance. The illumigene Pertussis DNA Amplification Assay is a laboratory test that provides a quantitative or qualitative result directly, without requiring human "reading" in the same diagnostic sense.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

Yes, for an IVD like the illumigene Pertussis DNA Amplification Assay, the performance data presented to the FDA always represents the standalone performance of the device (i.e., "algorithm only" in the context of an automated assay). The device generates a result which is then interpreted by a healthcare professional in conjunction with clinical information, but the core performance characteristics (sensitivity, specificity) are intrinsic to the assay itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For molecular diagnostic assays like the illumigene Pertussis DNA Amplification Assay, the ground truth is typically established using:

• Reference Culture: For bacterial infections, culture is often considered the gold standard, although its sensitivity for Bordetella pertussis can be low, especially in later stages of infection.
• Another highly sensitive and specific molecular method (e.g., a validated laboratory-developed PCR test or a previously cleared FDA PCR test), often with Sanger sequencing confirmation: This is frequently used as a composite reference standard when culture sensitivity is a concern.

The specific ground truth method used for this device is not provided in this document.

8. The sample size for the training set

• Training Set Sample Size: Not provided in this document. For molecular diagnostic assays, there isn't a "training set" in the machine learning sense. Instead, there are often development and validation phases where different sets of samples (sometimes called analytical and clinical validation sets) are used to establish performance. The term "training set" is more applicable to AI/ML devices.

9. How the ground truth for the training set was established

As mentioned in point 8, the concept of a "training set" with ground truth in the AI/ML context doesn't directly apply here. For the various validation studies (analytical and clinical), ground truth would be established by the reference methods described in point 7. The specific methodology for establishing ground truth for any development or validation samples is not provided in this document.

In summary: The provided FDA 510(k) clearance document confirms the device's legal market entry based on substantial equivalence for its stated Indications for Use. However, it does not detail the specific performance acceptance criteria or the comprehensive study design and results (e.g., sample sizes, ground truth methodology, actual sensitivity/specificity values) that were submitted to justify that equivalence. Such detailed information would typically be found in the full 510(k) summary or the device's instructions for use.

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