(99 days)
The QuickVue Influenza A + B test allows for the rapid, qualitative detection of influenza type A and type B antigens directly from nasal swab, nasal wash and nasal aspirate specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and type B viral infections. The test is not intended to detect influenza C antigens. The test is intended for professional and laboratory use.
The QuickVue Influenza A + B test, the successor product to the QuickVue Influenza test, has two Test Line indicators - one for type A and one for type B. The two Test Line indicators allow for the separate identification of type A and type B viral antigens from the same specimen. If either Test Line turns pinkto-red, the test is positive for influenza. Nasal swabs, nasal wash and/or nasal aspirates serve as specimens for this test. The patient specimen is placed in a tube containing Extraction Reagent, during which time the virus particles in the specimen are disrupted, exposing internal viral antigens. After extraction, the Test Strip is placed in the Extraction Tube for 10 minutes. During this time, the extracted specimen will react with the reagents in the Test Strip. If the extracted specimen contains influenza Type A and/or B antigens, a pink-to-red Test Line along with a blue procedural Control Line will appear on the Test Strip. If influenza Type A and B viral antigens are not present, or present at very low levels, only a blue procedural Control Line will appear. If no blue procedural Control Line develops, the result is considered invalid.
Here's a breakdown of the acceptance criteria and study information for the QuickVue® Influenza A + B test, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state pre-defined acceptance criteria (e.g., a specific sensitivity or specificity percentage target). Instead, it states that "Substantial equivalence has been demonstrated between the QuickVue test and viral culture for the qualitative detection of influenza Type A and B antigens." This implies that the device's performance, as measured in comparison to viral culture, was deemed acceptable by the FDA for establishing substantial equivalence to predicate devices.
However, the specific quantitative performance metrics (sensitivity, specificity) from the clinical study are not provided in this summary.
| Acceptance Criteria (Implied) | Reported Device Performance (Relative to Viral Culture) |
|---|---|
| Sufficient agreement with viral culture for qualitative detection of influenza A and B antigens to demonstrate substantial equivalence to predicate devices. | "Substantial equivalence has been demonstrated between the QuickVue test and viral culture for the qualitative detection of influenza Type A and B antigens." (Specific metrics not provided in summary) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The text mentions a "multi-clinical field study" but does not give the number of clinical specimens.
- Data Provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Retrospective. The text states: "a retrospective comparison of the QuickVue Influenza A + B test to viral culture was conducted in a multi-clinical field study."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. The ground truth was established by "viral culture." The qualifications of those performing or interpreting the viral culture are not specified.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study is not mentioned. The device is a "standalone" or "algorithm only" type of diagnostic, meaning human interpretation is based on the visible lines on the test strip, not assisted by an AI.
- Effect Size of Human Readers with AI vs. Without AI Assistance: Not applicable, as no AI assistance is mentioned.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, implicitly. The QuickVue® Influenza A + B test is a lateral-flow immunoassay, which is a standalone device providing a direct result (pink-to-red test line, blue control line) without human-in-the-loop AI assistance. The clinical study evaluated the performance of this device on its own.
7. Type of Ground Truth Used
- Ground Truth: Viral culture. The text states: "Substantial equivalence has been demonstrated between the QuickVue test and viral culture..."
8. Sample Size for the Training Set
This information is not provided in the document. As this is an immunoassay and not an AI/machine learning device, the concept of a "training set" in the context of data for model development is typically not applicable. The device's "training" would be its design and optimization during manufacturing and R&D phases.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a "training set" for an AI/ML model is not relevant for this immunodiagnostic device.
§ 866.3328 Influenza virus antigen detection test system.
(a)
Identification. An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria:
(i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method:
(A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method:
(A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent.
(B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent.
(2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies.
(3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria:
(i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains.
(ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or
(B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.
(4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access.