(77 days)
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 wash/aspirates 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 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 Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in samples processed from respiratory specimens. The processed specimen is added to the test device where influenza A or influenza B viral antigens bind to antiinfluenza antibodies conjugated to detector particles on the A+B test strip. The antigenconjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. Results are interpreted by the BD Veritor™ System Reader, a portable electronic device which uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip, and applies specific algorithms to determine the presence or absence of any target analyte(s). A liquid crystal display (LCD) on the instrument communicates the results to the operator.
- Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of predefined thresholds. However, it presents the performance characteristics of the BD Veritor™ System for Rapid Detection of Flu A+B test during clinical studies. The "performance" column will reflect the PPA and NPA values achieved by the device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Prospective Data) | Reported Device Performance (Retrospective Data) |
|---|---|---|---|
| Influenza A | (Not explicitly stated, generally high PPA/NPA expected for diagnostic devices) | PPA: 83.0% (95% C.I. 78.0%- 87.0%) | PPA: 92.1% (95% C.I. 82.7%- 96.6%) |
| NPA: 97.6% (95% C.I. 96.6%- 98.3%) | NPA: 98.9% (95% C.I. 96.2%- 99.7%) | ||
| Influenza B | (Not explicitly stated, generally high PPA/NPA expected for diagnostic devices) | PPA: 81.3% (95% C.I. 72.1%- 88.0%) | PPA: 74.0% (95% C.I. 58.9%- 85.4%) |
| NPA: 99.8% (95% C.I. 99.4%- 99.9%) | NPA: 99.0% (95% C.I. 96.6%- 99.7%) |
Note: While specific acceptance criteria are not called out, the FDA's clearance indicates that the observed performance was deemed acceptable for the intended use.
- Sample Size Used for the Test Set and Data Provenance:
- Prospective Test Set:
- Sample Size: 1471 evaluable clinical specimens (from an initial 1502 collected)
- Data Provenance: Multi-center clinical studies conducted at two U.S. trial sites and one Hong Kong trial site during the 2010-2011 respiratory season.
- Retrospective Test Set:
- Sample Size: 249 evaluable retrospective specimens (from an initial 263 collected)
- Data Provenance: Retrospective specimens, likely from banked samples, but specific origin beyond "retrospective" is not detailed.
- Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not mention the use of human experts to establish the ground truth for the clinical test sets. The ground truth was established by an "FDA-cleared influenza A and B molecular assay (PCR)."
- Adjudication Method for the Test Set:
Not applicable, as the ground truth was established by a laboratory assay (PCR) and not by expert review requiring adjudication.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This study focuses on the standalone performance of the BD Veritor™ System compared to PCR, not on how human readers' performance improves with or without the device.
- Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):
Yes, the study primarily assessed the standalone performance of the BD Veritor™ System for Rapid Detection of Flu A+B test. The device uses an "opto-electronic reader" to interpret results and apply algorithms, reporting a positive, negative, or invalid result on an LCD screen. This means the interpretation is automated by the device, making it a standalone assessment.
- The Type of Ground Truth Used:
The ground truth used for the clinical studies (both prospective and retrospective) was an FDA-cleared Influenza A and B molecular assay (PCR).
- The Sample Size for the Training Set:
The document does not explicitly state a separate training set size for the device's algorithms. The performance data presented is for the evaluation of the final device. For in-vitro diagnostic devices like this, the "training" (development and optimization) often happens with internal validation sets and analytical studies (like LOD, specificity, cross-reactivity) rather than a distinctly separated "training set" in the machine learning sense, before being tested on independent clinical cohorts.
- How the Ground Truth for the Training Set Was Established:
As a distinct "training set" is not explicitly mentioned for algorithmic development in the provided document, the method for establishing its ground truth is also not described. However, for any internal development and validation, the ground truth would typically be established using confirmed reference methods, similar to the PCR used for the clinical evaluation. Analytical studies (LOD, specificity, cross-reactivity) involved known concentrations of viral strains and specific microorganisms, which serve as a form of ground truth for characterizing the device's analytical capabilities.
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BD Veritor™ System for Rapid Detection of Flu A+B Clinical Laboratory Product
CONFIDENTIAL AND PROPRIETARY
MAR 2 3 2012
120049
510(k) SUMMARY
SUBMITTED BY:
BECTON, DICKINSON AND COMPANY 10865 Road to the Cure, Suite 200 San Diego, CA 92121 Phone: 858-795-7890 Fax: 858-812-8505
CONTACT NAME: Gregory Pavne
DATE PREPARED: March 15, 2012
DEVICE TRADE NAME: BD Veritor™ System for Rapid Detection of Flu A+B
DEVICE COMMON NAME: Influenza virus serological reagents
DEVICE CLASSIFICATION: 21 CFR § 866.3330
PREDICATE DEVICES: Quidel QuickVue Influenza A+B
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 nasopharyngeal wash/aspirates 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 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.
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.
BD Diagnostic Systems Becton, Dickinson and Company
Page 5
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DEVICE DESCRIPTION:
The BD Flu A+B test is a chromatographic assay to qualitatively detect influenza A and B viral antigens in samples processed from respiratory specimens. The processed specimen is added to the test device where influenza A or influenza B viral antigens bind to antiinfluenza antibodies conjugated to dètector particles on the A+B test strip. The antigenconjugate complex migrates across the test strip to the reaction area and is captured by an antibody line on the membrane. Results are interpreted by the BD Veritor™ System Reader, a portable electronic device which uses a reflectance-based measurement method to evaluate the line signal intensities on the assay test strip, and applies specific algorithms to determine the presence or absence of any target analyte(s). A liquid crystal display (LCD) on the instrument communicates the results to the operator.
BD Diagnostic Systems Becton, Dickinson and Company
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DEVICE COMPARISON:
The BD Veritor™ System for Rapid Detection of Flu A+B was compared to the Quidel QuickVue Influenza A+B test (K053146 and K092698).
| ProductFeature | BD Veritor™ System for Flu A+B | Quidel QuickVue Influenza A+B (K053146) | |
|---|---|---|---|
| Intended Use | The BD Veritor™ System for Rapid Detection ofFlu A+B is a rapid chromatographicimmunoassay for the direct and qualitativedetection of influenza A and B viral nucleoproteinantigens from nasopharyngeal wash/aspirates ofsymptomatic patients. The BD Veritor Systemfor Rapid Detection of Flu A+B is a differentiatedtest, such that influenza A viral antigens can bedistinguished from influenza B viral antigens froma single processed sample using a single device.The test is to be used as an aid in the diagnosisof influenza A and B viral infections. A negativetest is presumptive and it is recommended thatthese results be confirmed by viral culture or anFDA-cleared influenza A and B molecular assay.Negative test results do not preclude influenzaviral infection and should not be used as the solebasis for treatment or other patient managementdecisions. The test is not intended to detectinfluenza C antigens.Performance characteristics for influenza A andB were established during January throughMarch of 2011 when influenza viruses A/2009H1N1, A/H3N2, B/Victoria lineage, andB/Yamagata lineage were the predominantinfluenza viruses in circulation according to theMorbidity and Mortality Weekly Report from theCDC entitled "Update: Influenza Activity-UnitedStates, 2010-2011 Season, and Composition ofthe 2011-2012 Influenza Vaccine." Performancecharacteristics may vary against other emerginginfluenza viruses.If infection with a novel influenza virus issuspected based on current clinical andepidemiological screening criteria recommendedby public health authorities, specimens should becollected with appropriate infection controlprecautions for novel virulent influenza virusesand sent to the state or local health departmentfor testing. Virus culture should not be attemptedin these cases unless a BSL 3+ facility isavailable to receive and culture specimens. | The QuickVue® Influenza A+B test allows forthe rapid, qualitative detection of influenzatype A and type B antigens directly from nasalswab, nasopharyngeal swab, nasal aspirate,and nasal wash specimens. The test isintended for use as an aid in the rapiddifferential diagnosis of acute influenza type Aand type B viral infections. The test is notintended to detect influenza C antigens.Negative results should be confirmed by cellculture; they do not preclude influenza virusinfection and should not be used as the solebasis for treatment or other managementdecisions. The test is intended for professionaland laboratory use. | |
| SpecimenTypes | Nasopharyngeal wash/aspirates | Nasal swab, nasopharyngeal swab, nasalwash/aspirate | |
| AssayTechnology | Immunochromatographic | Immunochromatographic | |
| DetectionFormat | An opto-electronic reader determines the lineintensity at each of the spatially-defined test andcontrol line positions, interprets the results usingthe scoring algorithm, and reports a positive,negative, or invalid result on the LCD screenbased on pre-set thresholds. | Visual determination of presence or absenceof pink-to-red Test Line and the appearance ofa blue Procedural Control Line on the test stripindicate the presence of influenza A and/or Bantigen. | |
| Qualitative | Yes | Yes | |
| Total AssayTime | Approximately 10 minutes | Less than 15 minutes | |
| Control format | • Kit Flu A+/B- dry swab procedural control• Kit Flu B+/A- dry swab procedural control• Internal positive control• Internal negative control | • Kit Flu A+ control swab• Kit Flu B+ control swab• Kit Negative control swab• Internal control lines | |
| Detection ofFlu A and Bviruses | Differentiated influenza A and influenza B | Differentiated influenza A and influenza B |
BD Diagnostic Systems Becton, Dickinson and Company Page 7
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SUMMARY OF PERFORMANCE DATA:
Analytical Sensitivity
The limit of detection (LOD) for the BD Veritor System for Rapid Detection of Flu A+B test was established for a total of 7 influenza strains: 4 influenza B. The LOD for each strain represents the lowest concentration producing a positivity rate of approximately 95% based on testing 20 to 60 replicates.
| Type | Influenza Viral Strain | CalculatedLOD(TCID50/mL) | No.Positive/ Total | %Positive |
|---|---|---|---|---|
| A | A/Brisbane/10/2007 H3N2 | $7.27 x 10^2$ | 57/60 | 95% |
| A | A/Brisbane/59/2007 H1N1 | $3.30 x 10^2$ | 57/60 | 95% |
| A | A/California/7/2009 H1N1 | $5.00 x 10^3$ | 57/60 | 95% |
| A | A/Victoria/3/75 H3N2 | $3.11 x 10^3$ | 59/60 | 98.3% |
| B | B/Brisbane/60/2008 | $7.42 x 10^3$ | 58/60 | 96.7% |
| B | B/Florida/4/2006 | $1.30 x 10^3$ | 58/60 | 96.7% |
| B | B/Lee/40 | $4.44 x 10^4$ | 20/20 | 100% |
TCID50/mL = 50% Tissue Culture Infectious Dose
Analytical Specificity
A panel of 52 influenza viral strains including 20 Influenza A strains and 32 Influenza B strains were evaluated in triplicate with the BD Veritor™ System for Rapid Detection of Flu A+B test. All Influenza A viruses and all Influenza B viruses were correctly detected by the test.
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Cross Reactivity
A total of 51 microorganisms (36 bacteria, one yeast, and 14 viruses) were tested in triplicate with the BD Veritor™ System for Rapid Detection of Flu A+B test. None of the microorganisms tested were shown to be cross reactive with the test.
Interfering Substances
A variety of substances including whole blood, prescription medications and over-thecounter (OTC) medications, were tested with the BD Veritor™ System for Rapid Detection of Flu A+B test in triplicate at concentration levels comparable to or greater than levels that may be present in patient respiratory samples. None of the substances evaluated were shown to interfere with the performance of the test.
Media Compatibility
Ten different types of transport media commonly used for the preservation and transport of respiratory specimens were evaluated for compatibility with the BD Veritor™ System for Rapid Detection of Flu A+B test. The effects of frozen storage of transport media samples on the stability of the antigen were also evaluated in this study.
CLINICAL STUDIES Reproducibility
The reproducibility of the BD Veritor System for Rapid Detection of Flu A+B test was evaluated at three clinical laboratory sites. The reproducibility panel was composed of 30 simulated influenza A or B samples. These included moderate positive samples, low positive samples (near the assay limit of detection), high negative samples (i.e., containing very low concentrations of virus such that positive results occur ~5% of the time) and negative samples. The results are summarized below.
| Reproducibility Results - Percent of Flu A Positives | ||||
|---|---|---|---|---|
| Sample | Site 1 | Site 2 | Site 3 | Total |
| High negativeH1N1 A | 3.3% (1/30)(0.6%,16.7%) | 0.0% (0/30)(0.0%,11.3%) | 0.0% (0/30)(0.0%,11.3%) | 1.1% (1/90)(0.2%,6.0%) |
| Low positive H1N1A | 93.3% (28/30)(78.7%,98.2%) | 86.7% (26/30)(70.3%,94.7%) | 93.3% (28/30)(78.7%,98.2%) | 91.1% (82/90)(83.4%,95.4%) |
| Moderate positiveH1N1 A | 100.0% (30/30)(88.6%,100.0%) | 96.7% (29/30)(83.3%,99.4%) | 100.0% (30/30)(88.6%,100.0%) | 98.9% (89/90)(94.0%,99.8%) |
| High negativeH3N2 A | 16.7% (5/30)(7.3%,33.6%) | 3.3% (1/30)(0.6%,16.7%) | 0.0% (0/30)(0.0%,11.3%) | 6.7% (6/90)(3.1%,13.8%) |
| Low positive H3N2A | 93.3% (28/30)(78.7%,98.2%) | 86.7% (26/30)(70.3%,94.7%) | 93.3% (28/30)(78.7%,98.2%) | 91.1% (82/90)(83.4%,95.4%) |
| Moderate positiveH3N2 A | 100.0% (30/30)(88.6%,100.0%) | 100.0% (30/30)(88.6%,100.0%) | 96.7% (29/30)(83.3%,99.4%) | 98.9% (89/90)(94.0%,99.8%) |
| Flu A Negatives | 0.8% (1/120)(0.1%,4.6%) | 0.0% (0/120)(0.0%,3.1%) | 0.0% (0/119)(0.0%,3.1%) | 0.3% (1/359)(0.0%,1.6%) |
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| Reproducibility Results - Percent of Flu B Positives | ||||
|---|---|---|---|---|
| Sample | Site 1 | Site 2 | Site 3 | Total |
| High negative B | 3.3% (1/30)(0.6%,16.7%) | 0.0% (0/30)(0.0%,11.3%) | 0.0% (0/30)(0.0%,11.3%) | 1.1% (1/90)(0.2%,6.0%) |
| Low positive B | 90.0% (27/30)(74.4%,96.5%) | 63.3% (19/30)(45.5%,78.1%) | 82.8% (24/29)(65.5%,92.4%) | 78.7% (70/89)(69.0%,85.9%) |
| Moderatepositive B | 96.7% (29/30)(83.3%,99.4%) | 100.0% (30/30)(88.6%,100.0%) | 100.0% (30/30)(88.6%,100.0%) | 98.9% (89/90)(94.0%,99.8%) |
| Flu B Negatives | 0.0% (0/210)(0%,1.8%) | 0.0% (0/210)(0.0%,1.8%) | 0.0% (0/210)(0.0%,1.8%) | 0.0% (0/630)(0.0%,0.6%) |
:
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Clinical Performance
EXPECTED VALUES
The rate of positivity observed in respiratory testing will vary depending on the method of specimen collection, handling/transport system employed, detection method utilized, the time of year, age of the patient, geographic location, and most importantly, local disease prevalence. The overall prevalence observed with an FDA-cleared influenza A and B molecular assay in the U.S. during the 2010-2011 clinical study was 23.9% for influenza A and 7.5% for influenza B. At the clinical site located in Hong Kong, the prevalence observed with the same FDA-cleared influenza A and B molecular assay was 7.2% for influenza A and 3.4% for influenza B.
PERFORMANCE CHARACTERISTICS
Clinical Performance:
Performance characteristics for the BD Veritor System for Rapid Detection of Flu A+B test were established in multi-center clinical studies conducted at two U.S. trial sites and one Hong Kong trial site during the 2010-2011 respiratory season. A total of 1502 prospective specimens (1002 in the U.S and 500 in Hong Kong) were evaluated using the BD Veritor System for Rapid Detection of Flu A+B test and PCR. Five specimens were not evaluable because of data reconciliation issues, an additional 13 were excluded because of insufficient sample volume for reference method testing and 13 samples were excluded as "Result Invalid" (for an invalid rate of 0.9% [13/1484]). The prospective specimens consisted of nasopharyngeal washes and aspirates from symptomatic patients. 49% of the samples were from females and 51% from males. 56.6% were from patients less than or equal to 5 years of age. 21.9% of the patients tested were in the 6-21 year age group, 5.7% were from 22-59 years of age and 15.8% were obtained from people greater than or equal to age 60 (the patient age was not provided for 0.1% of samples).
The performance of the BD Veritor Svstem for Rapid Detection of Flu A+B test was compared to an FDA-cleared Influenza A and B molecular assay (PCR).
Explanation of Terms:
-
PPA: Positive Percent Agreement = a / (a+c) x 100%
NPA: Negative Percent Agreement = d / (b+d) x 100% -
P: Positive
-
N: Negative
-
C.I.: Confidence Interval
| Comparator Method | ||
|---|---|---|
| New TestMethod | P | N |
| P | a | b |
| N | c | d |
| Total | $(a+c)$ | $(b+d)$ |
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BD Veritor™ System for Rapid Detection of Flu A+B Clinical Laboratory Product
The performance is presented in Table 1 below. .
Table 1: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for All Nasopharyngeal Wash/Aspirate Specimens - All Sites
| Reference PCR | |||
|---|---|---|---|
| Clinical kit:BD Flu A | P | N | Total |
| P | 224 | 29 | 253 |
| N | 46 | 1172 | 1218 |
| Total | 270 | 1201 | 1471 |
| Reference Method: PCR.PPA: 83.0% (95% C.I. 78.0%- 87.0%)NPA: 97.6% (95% C.I. 96.6%- 98.3%) |
| Reference PCR | |||||
|---|---|---|---|---|---|
| Clinical kit:BD Flu B | P | N | Total | ||
| P | 74 | ਤੇ | 77 | ||
| N | 17 | 1377 | 1394 | ||
| Total | 01 | 1380 | 1471 | ||
| Reference Method: PCRPPA: 81.3% (95% C.I. 72.1%- 88.0%)NPA: 99.8% (95% C.I. 99.4%- 99.9%) |
An additional 263 frozen retrospective specimens were evaluated with the BD Veritor System for Rapid Detection of Flu A+B test. Twelve samples were excluded because there was insufficient sample volume for reference method testing, one sample was excluded as a PCR "Unresolved" and one sample was excluded as "Result Invalid" (for an invalid rate of 0.4% [1/250]). The retrospective specimens consisted of nasopharyngeal washes and aspirates from symptomatic patients. 44.9% of the samples were from females and 55.1% from males. 87.5% were from patients less than or equal to 5 years of age.
The performance is presented in Table 2 below.
Table 2: Summary of the Performance of the BD Veritor System for Rapid Detection of Flu A+B Test Compared to PCR for Retrospective Nasopharyngeal Wash/Aspirate Specimens
| Reference PCR | ||||
|---|---|---|---|---|
| Clinical kit:BD Flu A | P | N | Total | |
| P | 58 | 2 | 60 | |
| N | 5 | 184 | 189 | |
| Total | 63 | 186 | 249 | |
| Reference Method: PCRPPA: 92.1% (95% C.I. 82.7%- 96.6%)NPA: 98.9% (95% C.I. 96.2%- 99.7%) | ||||
| Reference PCR | ||||
| Clinical kit:BD Flu B | P | N | Total | |
| P | 29 | 2 | 31 | |
| N | 10 | 208 | 218 | |
| Total | 39 | 210 | 249 | |
| Reference Method: PCRPPA: 74.0% (95% C.I. 58.9%- 85.4%)NPA: 99.0% (95% C.I. 96.6%-99.7%) |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized emblem featuring a symbol resembling an abstract human figure or a bird-like shape with flowing lines.
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Becton, Dickinson and Company c/o Gregory P. Payne, RAC Director. Quality Systems and Regulatory Affairs 10865 Road to the Cure, Suite 200 San Diego, CA 92121
MAR 2 3 2012
Re: K120049
Trade/Device Name: BD Veritor™ System for Rapid Detection of Flu A + B Regulation Number: 21 CFR§ 866.3330 Regulation Name: Influenza Serological Reagents Regulatory Class: Class I Product Code: GNX Dated: January 5, 2012 Received: January 6, 2012
Dear Mr. Payne:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications . for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter
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Page 2 - Gregory P. Payne
will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number " (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Taliassimo
Sally A. Hojvat, M.Sc Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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BD Veritor " System for Rapid Detection of Flu A+B Clinical Laboratory Product
510(k) Number: K120049
Device Name: BD Veritor™ System for Rapid Detection of Flu A+B
Indications for 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 nasopharyngeal wash/aspirates 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 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.
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.
Over-the-Counter Use AND/OR Prescription Use V (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices Evaluation and Safety Taurana Felgla Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K120049
BD Diagnostic Systems Becton, Dickinson and Company Page 4
§ 866.3328 Influenza virus antigen detection test system.
(a)
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.(b)
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.