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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 nasopharyngeal and nasal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B is a differentiated test, such that influenza A viral antigens can be distinquished 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 neqative 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 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 D and added to the test device. RV Reagent D 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 eve is unable to accurately perform the subtraction of the nonspecific signal.

The provided text is a 510(k) summary for the BD Veritor™ System Flu A+B assay POC kit. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria or a detailed study report that proves the device meets those criteria with performance metrics such as sensitivity and specificity from a clinical trial.

The document mentions "Performance characteristics for influenza A and B were established during January through March of 2011..." but does not elaborate on these characteristics, the study design, sample sizes, ground truth establishment, or expert involvement. The primary change described in this 510(k) submission is the addition of analytical sensitivity (LOD) reactivity data for A/Anhui/1/2013 H7N9 and Strain Reactivity tables to the labeling, not a new clinical performance study for the original indications.

Therefore, many of the requested details cannot be extracted from this specific document.

Here's an attempt to answer based only on the provided text, highlighting what is not available:

Acceptance Criteria and Device Performance Study for BD Veritor™ System Flu A+B assay POC kit (K132259)

This 510(k) submission primarily addresses the addition of analytical sensitivity data for a new strain (A/Anhui/1/2013 H7N9) to the labeling of an already legally marketed device. It does not provide the detailed clinical performance study for the original device or specific acceptance criteria met by a clinical study. It refers to "Performance characteristics for influenza A and B were established during January through March of 2011" but does not provide the details of those characteristics or the study that established them.

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided 510(k) summary. The document states that performance characteristics were established but does not present them or the acceptance criteria they were measured against.

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

This information is not available in the provided 510(k) summary. The text mentions "Performance characteristics for influenza A and B were established during January through March of 2011," but does not detail the sample size or provenance of the data from this establishment.

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

This information is not available in the provided 510(k) summary.

4. Adjudication method for the test set

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary. The device is described as read by a "System Reader" which uses a proprietary algorithm, suggesting it's not a human-interpreted visual read in the final determination.

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

The device description implies a standalone algorithm's role, as "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." This suggests the interpretation of the test strip is done by the algorithm. However, no specific "standalone performance study" details (e.g., sensitivity, specificity of the algorithm alone) are provided.

7. The type of ground truth used

The intended use statement suggests that for negative results, confirmation by "viral culture or an FDA-cleared influenza A and B molecular assay" is recommended. This implies that for the original performance characteristics, such methods (viral culture or molecular assays) would likely have been used as the ground truth. However, this is an inference, and the document does not explicitly state how ground truth was established for the performance studies it references.

8. The sample size for the training set

This information is not available in the provided 510(k) summary.

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

This information is not available in the provided 510(k) summary.

Summary of What is Known from the Provided Text:

• Device: BD Veritor™ System Flu A+B assay POC kit, a rapid chromatographic immunoassay for direct and qualitative detection of influenza A and B viral nucleoprotein antigens.
• Intended Use: Aid in diagnosis of influenza A and B viral infections from nasopharyngeal and nasal swabs of symptomatic patients. It differentiates between Flu A and Flu B.
• Key Technology: Uses an active negative control feature and a proprietary algorithm in the BD Veritor™ System Reader to interpret test results by subtracting non-specific signal.
• Basis for 510(k): Substantial equivalence to the predicate device (K112277). The modification primarily concerns updating labeling with analytical sensitivity data for the A/Anhui/1/2013 H7N9 strain and strain reactivity tables.
• Performance Reference: "Performance characteristics for influenza A and B were established during January through March of 2011" against specific prevalent strains (A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage). Details of these characteristics and the studies are not included in this document.
• H7N9 Data: While new analytical sensitivity data for A/Anhui/1/2013 H7N9 was added, the labeling includes a disclaimer that "performance characteristics of this device with clinical specimens that are positive for the novel avian influenza A(H7N9) virus have not been established." This means the new data is analytical (LOD) and not clinical performance.

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