← Product Code [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ) · K160161 # BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K160161) _Becton, Dickinson & CO · PSZ · Feb 24, 2016 · Microbiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K160161 ## Device Facts - **Applicant:** Becton, Dickinson & CO - **Product Code:** [PSZ](/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ.md) - **Decision Date:** Feb 24, 2016 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 866.3328 - **Device Class:** Class 2 - **Review Panel:** Microbiology ## Intended Use 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. ## Device Story Rapid chromatographic immunoassay for qualitative detection of influenza A and B viral nucleoprotein antigens. Input: nasal/nasopharyngeal swabs mixed with mucolytic reagent. Operation: specimen added to test device; antigens bind to detector particle-conjugated antibodies; complexes migrate to reaction area; captured by striped antibodies. Device features five zones: positive control, negative control, background, and two test lines (A and B). Reader uses proprietary algorithm to subtract nonspecific signal (negative control/background) from test line signals; compares result to pre-selected cutoff. Output: positive/negative result displayed by reader. Used in point-of-care settings by healthcare professionals. Benefits: provides objective interpretation of results that may be difficult to score visually; aids in rapid clinical decision-making for influenza management. ## Clinical Evidence No new clinical data presented. Device relies on previously established performance characteristics from 2011 CDC-monitored influenza season. ## Technological Characteristics Immunochromatographic assay; utilizes mucolytic reagent for specimen processing. Features five spatially-distinct zones on test strip: positive control, negative control, background, and two analyte-specific test lines. Employs proprietary reader-based algorithm for signal subtraction and interpretation. Standalone reader system. ## Regulatory Identification An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection. The test aids in the diagnosis of influenza infection and provides epidemiological information on influenza. Due to the propensity of the virus to mutate, new strains emerge over time which may potentially affect the performance of these devices. Because influenza is highly contagious and may lead to an acute respiratory tract infection causing severe illness and even death, the accuracy of these devices has serious public health implications. ## Special Controls *Classification.* Class II (special controls). The special controls for this device are:(1) The device's sensitivity and specificity performance characteristics or positive percent agreement and negative percent agreement, for each specimen type claimed in the intended use of the device, must meet one of the following two minimum clinical performance criteria: (i) For devices evaluated as compared to an FDA-cleared nucleic acid based-test or other currently appropriate and FDA accepted comparator method other than correctly performed viral culture method: (A) The positive percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent. (B) The negative percent agreement estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent. (ii) For devices evaluated as compared to correctly performed viral culture method as the comparator method: (A) The sensitivity estimate for the device when testing for influenza A must be at the point estimate of at least 90 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 80 percent. The sensitivity estimate for the device when testing for influenza B must be at the point estimate of at least 80 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 70 percent. (B) The specificity estimate for the device when testing for influenza A and influenza B must be at the point estimate of at least 95 percent with a lower bound of the 95 percent confidence interval that is greater than or equal to 90 percent. (2) When performing testing to demonstrate the device meets the requirements in paragraph (b)(1) of this section, a currently appropriate and FDA accepted comparator method must be used to establish assay performance in clinical studies. (3) Annual analytical reactivity testing of the device must be performed with contemporary influenza strains. This annual analytical reactivity testing must meet the following criteria: (i) The appropriate strains to be tested will be identified by FDA in consultation with the Centers for Disease Control and Prevention (CDC) and sourced from CDC or an FDA-designated source. If the annual strains are not available from CDC, FDA will identify an alternative source for obtaining the requisite strains. (ii) The testing must be conducted according to a standardized protocol considered and determined by FDA to be acceptable and appropriate. (iii) By July 31 of each calendar year, the results of the last 3 years of annual analytical reactivity testing must be included as part of the device's labeling. If a device has not been on the market long enough for 3 years of annual analytical reactivity testing to have been conducted since the device received marketing authorization from FDA, then the results of every annual analytical reactivity testing since the device received marketing authorization from FDA must be included. The results must be presented as part of the device's labeling in a tabular format, which includes the detailed information for each virus tested as described in the certificate of authentication, either by: (A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where the analytical reactivity testing data can be found; or (B) In the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access. (4) If one of the actions listed at section 564(b)(1)(A)-(D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services (HHS) determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain: (i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate. The procedure and location of testing may depend on the nature of the emerging virus. (ii) Within 60 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by: (A) Placing the results directly in the device's § 809.10(b) of this chapter compliant labeling that physically accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or (B) In a section of the device's label or in other labeling that physically accompanies the device, prominently providing a hyperlink to the manufacturer's public Web site where the analytical reactivity testing data can be found. The manufacturer's home page, as well as the primary part of the manufacturer's Web site that discusses the device, must provide a prominently placed hyperlink to the Web page containing this information and must allow unrestricted viewing access. ## Predicate Devices - BD Veritor™ System for Rapid Detection of Flu A+B CLIA waived kit ([K112277](/device/K112277.md), [K132259](/device/K132259.md), [K132692](/device/K132692.md), [K151291](/device/K151291.md), [K152870](/device/K152870.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SPECIAL 510(k): Device Modification OIR Decision Summary To: THE FILE RE: DOCUMENT NUMBER K160161 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class I devices requiring 510(k). The following items are present and acceptable: 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. K152870 BD Veritor™ System for Rapid Detection of Flu A+ B CLIA Waived kit K112277, K132259, K132256, K151301 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use. 3. A description of the device MODIFICATION, including a statement that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. Changes to the labeling include the addition of two influenza A/H5 strains to the reactivity section of currently marketed BD Veritor™ System Flu A+ B CLIA Waived kit Assay Product Insert. A list of the strains tested is included in Table 1 below. Table 1 | No. | Strain | Final Dilution Factor | Minimal Detected Concentration^{1} | | --- | --- | --- | --- | | 1 | A/Northern Pintail/Washington/40964/2014 (H5N2) | 4000 | 6.28 × 10^{5} EID_{50}/mL | | 2 | A/Gyrfalcon/Washington/41088-6/2014 (H5N8) | 8000 | 1.98 × 10^{6} EID_{50}/mL | 1. The lowest concentration of influenza A virus strain that can be detected by the BD Veritor™ System Flu A + B Assay in 3/3 replicates. The fundamental scientific technology of the modified device has not changed. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics. Table 2 | Comparison to Predicate Device | | | | --- | --- | --- | | Similarities: | | | | Product Feature | Currently Marketed Veritor™ System Flu A + B CLIA Waived kit (K152870) | Product Modification | | Intended use | 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 | Unchanged | {1} Page 2 of 4 | | 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. Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity-United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses. If infection with a novel influenza 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 the state or local health department for testing. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens. | | | --- | --- | --- | | Specimen type | Nasal and nasopharyngeal swabs of symptomatic patients. | Unchanged | | Assay technology | Chromatographic immunoassay | Unchanged | | Detection Format | An opto-electronic reader determines the line intensity at each of the spatially defined test and control line positions, interprets the results using a scoring algorithm, and reports a positive, negative or invalid result on the LCD screen based on pre-set thresholds. | Unchanged | {2} Page 3 of 4 | Qualitative or Quantitative | Qualitative | Unchanged | | --- | --- | --- | | Assay run time | approximately 10 minutes | Unchanged | | Control format | • Kit Flu A+/B- dry swab procedural control • Kit Flu A-/B+ dry swab procedural control • Internal positive control • Internal negative control | Unchanged | | Detection of Flu A and B viruses | Differentiation of Flu A vs. Flu B | Unchanged | | Comparison to Predicate Device | | | | --- | --- | --- | | Differences: | | | | Product Feature | Currently Marketed Veritor™ System Flu A + B CLIA Waived kit (K152870) | Product Modification | | Analytical Strain Reactivity Tables in Labeling (Package Insert) | Current Product Package Insert includes 79 Flu Strains; 37 Flu A and 42 Flu B in the Analytical Strain reactivity tables. | Analytical Strain reactivity tables in the Labeling will include two additional Influenza A/H5 strains | 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis. The Risk Assessment process used was based on a BD Product Risk Management procedure, which, according to the sponsor, meets the requirement for risk management as set forth in ISO 14971:2007 and EN ISO 14971:2012. Using this procedure, the following characteristics were assessed and the results are presented in Table 3 below: - The Hazard, - The Adverse Effect (Harm to Patient), - The Potential Causes of the Hazard, - The probability of Hazard Severity and - The probability of Occurrence {3} Table 3 | Hazard | False Negative | | Risk Control Measure | Testing | | --- | --- | --- | --- | --- | | Adverse Effect (Harm) | Effect on patient is that they could be inappropriately treated leading to flu progression | | | Obtain and test additional flu strains | | Probability of Severity | Moderate | | | Labeling | | Potential Causes of the Hazard | Assay does not detect the strains | | | Update PI with new reactivity after FDA special 510(k) clearance | | Probability of Occurrence | Occasional | | Risk Control Measure Effectiveness Reference | SDSP15001 | | Existing Risk Control Measure | Current strain reactivity has been determined and is provided in the Product Insert | | Probability of Severity | Moderate | | Risk Index | Investigate | | Probability of Occurrence | Improbable | | Responsibility for Risk Control Measure | R&D | | Risk Index | Insignificant | b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. The risk assessment identified the need to confirm the Veritor System's reactivity to the CDC H5Nx Virus Panel provided as part of the Pandemic Influenza Preparedness (PIP) Framework and to add the results to a package insert available to the public. In order to demonstrate reactivity with the A/H5 viruses and present the data in a revised Package Insert, a reactivity study was conducted. The study acceptance criterion was a positive instrument read with samples of the subject influenza viruses when tested by the BD Veritor™ Flu A+B CLIA Waived kit assay. The lowest concentrations of influenza A/H5 viruses that were detected by the Veritor™ System Flu A+B assay are listed in Table 1. The strain reactivity data provided above and proposed for inclusion into the PI demonstrate that all strains tested met the acceptance criteria. The studies conducted on the BD Veritor™ System Flu A+B assay support the proposed labeling changes to reflect the analytical reactivity data generated. This data will be used to update the strain reactivity section of the product insert. The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device. --- **Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K160161](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/PSZ/K160161) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com