(29 days)
The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV antigen from nasopharyngeal washes/aspirates and nasopharyngeal swabs in transport media from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in neonatal and pediatric patients under the age of 20. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor™ System Reader.
The BD Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in respiratory specimens. The patient specimen is mixed in a prefilled unitized tube containing RV Reagent C and added to the test device. RV Reagent C contains mucolytic agents that function to break down mucus in a patient specimen thereby exposing viral antigens and enhancing detection in the assay device. Processed specimens are expressed through a filter tip into a single sample well on the BD Flu A+B test device.
The specimen is mixed and added to the test device where influenza A or influenza B viral antigens bind to anti-influenza antibodies conjugated to detector particles on the BD Flu A+B test strip. The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. The assay utilizes a proprietary enhanced colloidal-gold particle at the test lines as the means for identifying the presence of influenza A or B viral antigens.
The BD Flu A+B test devices are designed with five spatially-distinct zones including positive and negative control line positions, separate test line positions for the target analytes, and a background zone. The test lines for the target analytes are labeled on the test device as 'A' for Flu A position, and 'B' for Flu B position. The onboard positive control ensures the sample has flowed correctly and is indicated on the test device as 'C'. Two of the five distinct zones on the test device are not labeled. These two zones are an onboard negative control line and an assay background zone. The onboard negative control zone addresses non-specific signal generation and is not labeled on the test device. The remaining zone is used to measure the assay background and is also not labeled.
The BD Flu A+B assay incorporates an active negative control feature in each test to identify and compensate for sample-related, nonspecific signal generation. The BD Veritor™ System Reader uses a proprietary algorithm which subtracts nonspecific signal at the negative control line from the signal present at both the Flu A and Flu B test lines. If the resultant test line signal is above a pre-selected assay cutoff, the specimen is scored as positive. If the resultant test line signal is below the cutoff, the specimen is scored as negative. Use of the active negative control feature allows the BD Veritor™ System reader to correctly interpret test results that cannot be scored visually because the human eye is unable to accurately perform the subtraction of the nonspecific signal.
The provided text describes a 510(k) premarket notification for a modification to the BD Veritor™ System Flu A+B assay, specifically regarding the ability to test excess processed sample in the BD Veritor™ RSV clinical assay. This document does NOT contain a study that proves the device (BD Veritor™ System Flu A+B assay) meets acceptance criteria for its primary function. Instead, it focuses on demonstrating substantial equivalence for a modification related to cross-testing with another BD product (RSV assay).
Therefore, I cannot fulfill all your requests as the complete performance study data and acceptance criteria for the primary influenza detection function are not detailed in this submission. The document states that performance characteristics for the Flu A+B assay were established during specific influenza seasons, implying that studies were done, but the results and detailed acceptance criteria for those original studies are not provided here.
However, I can extract information related to the context of its performance and the type of information typically found in such submissions.
Here's a breakdown of what can be derived from the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
The provided document does not list specific acceptance criteria or detailed performance data for the BD Veritor™ System Flu A+B assay. It mentions that performance characteristics were "established" during certain influenza seasons but does not present the actual data (e.g., sensitivity, specificity, PPA, NPA values).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions that performance characteristics were established during:
- January through March of 2011 for nasopharyngeal (NP) washes/aspirates.
- January through April of 2012 for NP swabs in transport media.
It states these periods were when specific influenza viruses (A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage) were predominant, according to CDC reports. This implies the data was collected prospectively during active influenza seasons in the United States.
The sample size for the test set is NOT specified in this document.
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)
This information is NOT specified in this document. The ground truth method is implied to be viral culture or an FDA-cleared molecular assay (see point 7), but details on the experts involved in interpreting results or establishing ground truth are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is NOT specified in this document.
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 a diagnostic device, not an AI-assisted interpretation device. The BD Veritor™ System Reader uses a proprietary algorithm to interpret test results by subtracting non-specific signals, but it does not involve human readers in the interpretation process in the way an MRMC study for imaging interpretation would. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself (BD Veritor™ System Flu A+B) operates in a "standalone" fashion in terms of interpretation, meaning the BD Veritor™ System Reader interprets the test strip results algorithmically without human visual interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document states:
- "A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay."
- For the RSV assay (which the modification allows cross-testing with), it states: "It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay."
This strongly indicates that viral culture or FDA-cleared molecular assays were used as the ground truth.
8. The sample size for the training set
The document describes a modification to an existing device and does not provide information on the training set size for the original device's development or for the algorithmic interpretation by the BD Veritor™ System Reader.
9. How the ground truth for the training set was established
This information is NOT specified in this document. As it's a 510(k) submission for a modification, details on the original device's development, including training set ground truth establishment, are typically not included unless directly relevant to the modification.
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(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 § 866.9.