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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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