(32 days)
The QuickVue Influenza Test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal aspirate, and nasal wash specimens. The test is intended for use as an aid in the rapid diagnosis of acute influenza virus infection. The test is not intended to detect influenza C antigens. Negative test results should be confirmed by cell culture; they do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.
The QuickVue Influenza Test involves the extraction of influenza A and B viral antigens. The patient specimen is placed in the Extraction Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After extraction, the Test Strip is placed in the Extraction Reagent Tube where nucleoproteins in the specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip indicating a positive result. If influenza type A or type B antigens are not present, or are present at very low levels, only a blue procedural Control Line will appear.
The provided text contains information about a 510(k) submission for the QuickVue® Influenza test. However, it does not contain acceptance criteria or detailed study results that would allow for a complete description as requested. The document primarily focuses on establishing substantial equivalence to a predicate device and includes a brief analytical study for H7N9 detection.
Here's an analysis based on the available information, noting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the given text. A typical 510(k) summary for a diagnostic test would include sensitivity, specificity, and potentially positive and negative predictive values, along with their acceptance criteria. The document only mentions a "minimum detectable level" for H7N9.
| Acceptance Criteria (e.g., Sensitivity, Specificity, LoD) | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
| Minimum detectable level for Influenza A (H7N9) | 1.98 x 10^7 EID50/mL |
2. Sample Size Used for the Test Set and Data Provenance
The document describes an "analytical study" to assess the ability to detect H7N9 and establish the Limit of Detection (LoD). It does not specify a sample size for this analytical study.
- Sample Size for Test Set: Not explicitly stated for the analytical study mentioned.
- Data Provenance: Not specified, but given it's an "analytical study" focused on LoD, it typically involves prepared samples (e.g., spiked samples or known concentrations of virus) rather than patient specimens. The document doesn't mention a clinical study with patient samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an analytical study establishing Limit of Detection, ground truth is typically established by the known concentration of the analyte in the prepared samples, not by expert review of test results. If a clinical study were performed (which is not described in detail here), expert-adjudicated ground truth might be relevant.
4. Adjudication Method for the Test Set
This information is not provided. Given that the described study is analytical to determine LoD, an adjudication method for test interpretation by multiple readers is not relevant. The result (presence/absence of a test line) is read directly from the test strip.
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
This is not applicable and not mentioned. The QuickVue® Influenza test is a visual, qualitative immunoassay designed for direct interpretation, not an AI-assisted diagnostic device where human readers interact with AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. The QuickVue® Influenza test is a lateral flow immunoassay that requires human interpretation of visual lines for a positive or negative result. It does not involve an algorithm working independently.
7. The Type of Ground Truth Used
For the analytical study mentioned (LoD for H7N9), the ground truth would be based on the known concentration of the H7N9 virus in the prepared samples used to determine the detection limit.
- Type of Ground Truth: Known viral concentration (for the LoD study).
8. The Sample Size for the Training Set
This information is not provided. For a rapid immunoassay like the QuickVue® Influenza test, there isn't typically a "training set" in the machine learning sense. Assay parameters are optimized through biochemical development and analytical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a "training set" in the context of an AI/machine learning algorithm for this device. For the development and optimization of such an immunoassay, the "ground truth" during development would be established through careful analytical studies using known positive and negative samples, and samples with known concentrations of the target analyte.
§ 866.3330 Influenza virus serological reagents.
(a)
Identification. Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.