(32 days)
The Lyra Influenza A+B Assay is a multiplex Real Time RT-PCR assay for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This test is intended for use as an aid in the differential diagnosis of influenza A and influenza B viral infections in humans in conjunction with clinical and endemiological risk factors. The assay does not detect the presence of influenza C virus.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2013 influenza seasons when influenza A/H3 and 2009 H1N1 influenza were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
The assay can be performed using either the Life Technologies QuantStudio Dx, the Applied Biosystems 7500 Fast Dx or the Cepheid SmartCycler II.
The Lyra Influenza A+B Assay detects viral RNA that have been extracted from a patient sample using the NucliSENS easyMAG or EMAG automated extraction platform. A multiplex RT-PCR is carried out under optimized conditions in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Life Technologies QuantStudio™ Dx, the Applied Biosystems® 7500 Fast Dx, or the Cepheid® SmartCycler® II. Identification of influenza A occurs by the use of target specific primers and a fluorescent-labeled probe that hybridizes to a conserved influenza A sequence within the matrix protein gene. Identification of influenza B occurs by the use of target specific primers and fluorescent-labeled probes that will hybridize to a conserved influenza B sequence within the neuraminidase gene.
The provided text describes a 510(k) premarket notification for the Lyra Influenza A+B Assay. The notification primarily focuses on a modification to the device, specifically the inclusion of a new nucleic acid extraction platform (BioMerieux NucliSENS EMAG) while maintaining the original intended use and other core functionalities.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document explicitly states that "All verification and validation activities were performed in accordance with relevant standards, established plans, protocols, and Design Control procedures. Testing verified all acceptance criteria were met." However, the specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) are not detailed in the provided text. Similarly, the specific quantitative reported device performance metrics (e.g., exact sensitivity and specificity values) from the studies are not presented in the provided summary.
The summary only states: "Non-clinical and clinical verification activities conducted with the Lyra Influenza A+B Assay demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device."
2. Sample Sizes Used for the Test Set and Data Provenance
The text mentions a "Clinical Equivalency Study" but does not provide details on the sample size used for its test set or the data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of Experts and Qualifications for Ground Truth
The document does not provide information on the number of experts used to establish ground truth for the test set or their qualifications.
4. Adjudication Method for the Test Set
The document does not provide information on the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The text does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The focus is on the performance of the assay itself, not human reader improvement with/without AI assistance.
6. Standalone Performance Study
The studies mentioned ("Limit of Detection Equivalency Study" and "Clinical Equivalency Study") describe the performance of the device (algorithm/assay only), implying a standalone performance evaluation. However, the text does not explicitly use the term "standalone" or specify that it was "algorithm only without human-in-the-loop performance." Given that it's an RT-PCR assay, its performance by definition is standalone.
7. Type of Ground Truth Used
The text does not explicitly state the type of ground truth used for the clinical equivalency study. For diagnostic assays like this, ground truth is typically established through a combination of:
- Confirmatory laboratory methods (e.g., viral culture, another highly sensitive and specific PCR method, or sequencing as a gold standard).
- Clinical diagnosis by a physician.
However, this information is not provided.
8. Sample Size for the Training Set
The text does not provide information on a training set sample size. This is a modification to an existing assay, and the studies mentioned are verification/validation studies for the modification, not development studies for a new algorithm that would typically involve a separate training set.
9. How Ground Truth for the Training Set was Established
Since no training set information is provided, there is no information on how its ground truth was established.
Summary of Missing Information:
A significant amount of detail regarding the studies, particularly the quantitative acceptance criteria, reported performance, sample sizes, and ground truth methodologies, is not present in the provided FDA 510(k) summary letter. The letter serves as an approval notification and summary of the device's substantial equivalence, focusing on the change (new extraction platform) rather than a comprehensive, detailed clinical study report.
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.