(22 days)
The Verigene® Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATsp) is a qualitative multiplex in vitro diagnostic test for the detection and identification of Influenza A Virus, Influenza B Virus, and Respiratory Syncytial Virus (RSV) nucleic acids purified from nasopharyngeal swab specimens obtained from patients symptomatic for viral upper respiratory infection. The test is intended to be used on the Verigene SP System as an aid in the differential diagnosis of Influenza A, Influenza B, and RSV infections. The test is not intended to detect Influenza C virus.
Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative test results be confirmed by culture.
Performance characteristics for Influenza A Virus were established when Influenza A/H3 and A/H1 were the predominant Influenza A viruses in circulation. As Influenza A viruses emerge, 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.
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This document is a 510(k) clearance letter for the "Verigene® Respiratory Virus Nucleic Acid Test on the Verigene SP System (RVNATSP)." It describes the device's intended use and substantial equivalence to a predicate device. However, it does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report or a more comprehensive 510(k) submission summary.
Therefore, many of the requested fields cannot be directly answered from this document.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted: This document does not provide acceptance criteria or detailed performance data (e.g., sensitivity, specificity, accuracy). It only mentions that performance characteristics for Influenza A Virus were established for specific subtypes.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted: The document does not specify the sample size, data provenance, or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be extracted: The document does not mention experts, their number, or qualifications related to establishing ground truth for the test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted: The document does not describe any adjudication method.
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
- N/A: This device is a diagnostic nucleic acid test, not an AI-assisted imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Applicable, but details not provided: As an in vitro diagnostic test, the "algorithm only" performance (i.e., the diagnostic test itself) is what is assessed. However, the performance metrics (sensitivity, specificity) are not provided in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicitly standard of care/reference method, but not explicitly stated: For a nucleic acid test, the ground truth would typically be established by a highly sensitive and specific reference method, such as culture or another validated molecular test. The document mentions "Negative results do not preclude influenza virus or RSV infection and should not be used as the sole basis for treatment or other management decisions. It is recommended that negative test results be confirmed by culture," which suggests culture might be part of the ground truth or a confirmatory method. However, the specific method for establishing ground truth for the primary study is not explicitly detailed.
8. The sample size for the training set
- Cannot be extracted: This document does not provide details about a training set since it's a 510(k) clearance letter, not a full study report for an AI/machine learning device.
9. How the ground truth for the training set was established
- Cannot be extracted: As above, details about a training set or its ground truth establishment are not present.
§ 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.