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The BD Veritor System for Rapid Detection of Flu A+B CLIA waived assay is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. 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. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral antigens from nasopharyngeal and nasal swabs of symptomatic patients. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. It is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single test device. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other management decisions. All negative test results should be confirmed by another methodology, such as a nucleic acid-based method.

BD Veritor™ System Flu A+B test devices are interpreted by a BD Veritor™ Plus Analyzer. When using the BD Veritor™ Plus Analyzer, workflow steps depend on the selected operational mode and the Analyzer configuration settings. In Analyze Now mode, the instrument evaluates assay devices after manual timing of their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of assay development and analysis is automated. Depending on the configuration chosen by the operator, the instrument communicates status and results to the operator via a liquid crystal display (LCD) on the instrument, a connected printer, or through a secure connection to the facility's information system.

This document (K223016) is a 510(k) Premarket Notification for a modified version of the BD Veritor System for Rapid Detection of Flu A+B CLIA-Waived Kit. The core assay (the rapid immunoassay for Influenza A and B detection) remains unchanged from previous clearances (K180438 and earlier). The modifications focus on the accompanying instrument, the BD Veritor™ Plus Analyzer.

Therefore, the document explicitly states "There have been no changes to the analytical performance of the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit since the assay was last cleared in K180438. The modifications to the Analyzer do not have an impact on the assay-specific analytical performance. " and "There have been no changes to the clinical performance of the BD Veritor™ System for Rapid Detection of Flu A+B CLIA-Waived Kit since the assay was last cleared in K180438. The modifications to the Analyzer do not have an impact on the assay-specific clinical performance."

This means that no new performance studies (analytical or clinical) were conducted for the assay itself as part of this specific 510(k) submission. The acceptance criteria and performance data for the assay would refer to the studies presented in the previous 510(k)s, most recently K180438.

The testing performed for this K223016 submission focuses solely on the modifications made to the BD Veritor™ Plus Analyzer:

1. Overvoltage Protection Circuitry: Testing confirms that the added circuitry does not affect the function of the trigger board (recognition of a cartridge and USB connection).
2. Extended Lifetime: Verification that the Analyzer performs up to 10,000 cycles (tests) within current specifications (increased from 3,500 tests).
3. InfoWiFi Module Functionality: Verification of the general functionalities of the new InfoWiFi module, which provides wireless communication capabilities.

Since the provided document does not contain the details of the analytical and clinical performance studies for the assay, and instead refers to previous submissions, I cannot extract the specific acceptance criteria and detailed study data for the assay itself from this text.

Assuming the request is for the acceptance criteria and study proving the changes to the analyzer meet the criteria, the following applies:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated in the document for any of the new tests. The document refers to "testing was performed."
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would typically be non-clinical, in-house verification testing by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable as this is a device modification verification, not a clinical study requiring expert ground truth for diagnostic accuracy. The "truth" here is engineering functionality.

4. Adjudication method for the test set:

• Not applicable. This is not a study requiring adjudication of diagnostic results.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This type of study is for evaluating human reader performance with or without AI assistance. The modifications here are to the hardware of an automated test reader, not an AI diagnostic algorithm.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• The BD Veritor System itself operates as a standalone diagnostic device interpreted by the analyzer. However, the algorithm for interpreting the test results (analyzing line intensity) was established in previous submissions (K180438) and is stated as "Same" and "Original" in the comparison table, meaning it was not changed or re-evaluated in this submission. The testing done for this 510(k) relates to the hardware modifications of the analyzer, not a new or modified interpretation algorithm.

7. The type of ground truth used:

• For the hardware modifications, the "ground truth" is defined by engineering specifications and expected functionality. For example, for "overvoltage protection," the ground truth is "does the circuit protect against overvoltage without impairing core function?" For "lifetime," the ground truth is "does the device successfully complete 10,000 tests?" For "InfoWiFi," the ground truth is "does it perform the specified wireless functionalities?"

8. The sample size for the training set:

• Not applicable. This is hardware verification, not a machine learning model.

9. How the ground truth for the training set was established:

• Not applicable.

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The BD Veritor System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. 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. Outside the U.S., a negative test is presumptive and it is recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country of use. FDA has not cleared this device for use outside of the U.S. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

The BD Veritor™ Flu A+B test is an immunochromatographic assay for the qualitative detection of influenza A and B viral antigens in respiratory specimens. The patient specimen is mixed in a reaction tube prefilled with RV Reagent C, gently mixed, and then 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 Veritor™ Flu A+B test device.

After addition to the test device, any influenza A or influenza B viral antigens present in the specimen bind to anti-influenza antibodies conjugated to detector particles on the Veritor™ Flu A+B test strip. The antigen-conjugate complexes migrate across the test strip to the reaction area and are captured by a line of antibody striped on the membrane. The Veritor™ 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 neqative control line and an assay background zone. The onboard negative control zone addresses non-specific signal generation. The remaining zone is used to measure the assay background.

The BD Veritor™ 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 that 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 scores as positive. If the resultant test line signal is below the cutoff, the specimen scores 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.

This document describes an FDA 510(k) submission for the BD Veritor™ System for Rapid Detection of Flu A + B CLIA Waived Kit. This submission is for a modification to an already marketed device, primarily concerning the addition of strain reactivity data to the labeling. Therefore, the information provided below is extracted from the context of this modification rather than a de novo submission for a new device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity thresholds) that were set for this particular 510(k) amendment. This submission focuses on adding strain reactivity data to the device's labeling. Therefore, the "reported device performance" in this context refers to the strain reactivity data that was added. The original device would have had its own acceptance criteria and performance studies, which are not detailed in this specific document.

• A/California/02/2014 (H3N2)
• B/Brisbane/33/2008 (Victoria Lineage)
• B/Guangdong-Liwan/1133/2014 (Yamagata Lineage)
• B/Hong Kong/259/2010 (Victoria Lineage)
• B/Texas/02/2013 (Victoria Lineage)
• B/Utah/09/2014 (Yamagata Lineage) |

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the testing of the new strains. It only states that "strain reactivity data" was added. The provenance of this data (e.g., country of origin, retrospective/prospective) is also not detailed for these specific strain reactivity tests.

However, the general performance characteristics for influenza A and B for the original device were "established during January through March of 2011" when specific influenza viruses were in circulation. This suggests the original validation involved prospective clinical samples from the U.S., but the details like sample size for that original validation are not in this document.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number or qualifications of experts used to establish ground truth for the strain reactivity data specifically, or for the original clinical validation. The device is for rapid detection of viral antigens, and ground truth for such devices typically relies on more definitive laboratory tests like viral culture or molecular assays, rather than expert consensus on interpretation of the device's results.

4. Adjudication Method for the Test Set

The document does not describe any adjudication methods for the test set, as its focus is on adding strain reactivity data, not on a clinical trial with human interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done, nor is it relevant given the nature of this rapid diagnostic test described. The device is interpreted by a "BD Veritor™ System Reader" using a proprietary algorithm, not by human readers interpreting images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this device inherently functions as a standalone (algorithm only) system in terms of result interpretation. The "BD Veritor™ System Reader" uses a "proprietary algorithm" to interpret the test strip and provide a result, subtracting non-specific signals. The human user's role is to perform sample preparation and insert the device into the reader, not to visually interpret the test lines.

7. The Type of Ground Truth Used

For the specific strain reactivity data added, the document does not explicitly state the ground truth method. However, for a device detecting influenza viral antigens, the standard ground truth for establishing performance (as referenced in the "Indications for Use" and "Intended Use" sections for negative results) would be:

• Viral Culture: Considered the traditional gold standard.
• FDA-cleared influenza A and B molecular assay: Modern standard for definitive diagnosis.

It's highly probable that these methods were used to confirm the presence and type of virus for the new strains tested for reactivity.

8. The Sample Size for the Training Set

The document does not provide information about a training set since this is a rapid diagnostic kit with a fixed detection mechanism. Machine learning models typically have training sets, but this device uses a proprietary algorithm within a reader that interprets optical signals from a lateral flow assay. The initial development of such an algorithm would involve internal validation and optimization, but the term "training set" in the context of deep learning is not applicable here.

9. How the Ground Truth for the Training Set Was Established

As noted above, the concept of a "training set" in the context of a machine learning-based algorithm is not directly applicable to this device as described. The algorithm in the BD Veritor™ System Reader optically reads the test lines and performs calculations based on pre-defined cutoffs and signal subtraction. The "ground truth" for developing this reading algorithm would be based on expertly characterized positive and negative control samples, and samples with known viral loads and types, using methods like viral culture or molecular assays to confirm their status. The document does not detail this developmental process.

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