Acucy Influenza A&B Test with the Acucy System

K182001 · SEKISUI Diagnostics, LLC · PSZ · Dec 17, 2018 · Microbiology

Device Facts

• Record ID: K182001
• Device Name: Acucy Influenza A&B Test with the Acucy System
• Applicant: SEKISUI Diagnostics, LLC
• Product Code: PSZ · Microbiology
• Decision Date: Dec 17, 2018
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 866.3328
• Device Class: Class 2

Intended Use

The Acucy™ Influenza A&B Test for the rapid qualitative detection of influenza A and B is composed of 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 that is automatically analyzed on the Acucy Reader. The Acucy Influenza A&B Test 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 Cassette. The test is intended for use with the Acucy System as an aid in the diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should 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.

Device Story

Device is a lateral flow immunochromatographic assay for influenza A and B detection. Input: nasal or nasopharyngeal swab samples processed in extraction buffer. Operation: sample migrates on nitrocellulose membrane; viral antigens bind to colloidal gold-conjugated monoclonal antibodies; complex captured by membrane-bound antibodies. Acucy Reader (optoelectronic instrument) scans cassette, measures reflectance-based absorbance intensity, and processes results via method-specific algorithms. Output: POS, NEG, or INVALID result displayed on screen or printed. Used in clinical laboratories and point-of-care settings (urgent care, clinics) by healthcare personnel. Provides rapid differential diagnosis; aids clinical decision-making; negative results require confirmatory testing.

Clinical Evidence

Prospective, multi-center study (1,003 evaluable samples) conducted during 2017-2018 influenza season at 16 U.S. POC sites. Compared against composite reference (two FDA-cleared molecular assays and cell culture). Influenza A sensitivity: 96.4% (95% CI: 93.1%-98.2%), specificity: 96.0% (95% CI: 94.4%-97.2%). Influenza B sensitivity: 82.3% (95% CI: 75.6%-87.4%), specificity: 98.1% (95% CI: 96.9%-98.8%). Reproducibility and near-cutoff studies confirmed performance by untrained operators.

Technological Characteristics

Lateral flow immunochromatographic assay; sandwich immunoassay format. Nitrocellulose membrane; colloidal gold-conjugated mouse monoclonal antibodies. Reflectance-based optoelectronic reader. Dimensions/form factor: Test Cassette and Reader. Connectivity: USB memory drive, printer output. Software: Method-specific algorithms for signal intensity analysis. Sterilization: Not specified.

Indications for Use

Indicated for rapid qualitative detection of influenza A and B viral nucleoprotein antigens in nasal and nasopharyngeal swabs from symptomatic patients. Intended as an aid in diagnosis of influenza A and B infections. Not for influenza C detection. Negative results are presumptive and require confirmation by culture or molecular assay.

Regulatory Classification

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

• Quidel Sofia® Analyzer and Influenza A+B FIA (K112177, K131606, K153012)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

## December 17, 2018

Sekisui Diagnostics, LLC Shelly Harris Director of Regulatory Affairs 6659 Top Gun St. San Diego, California 92121

Re: K182001

Trade/Device Name: Acucy Influenza A&B Test with the Acucy System Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza virus antigen detection test system Regulatory Class: Class II Product Code: PSZ Dated: July 25, 2018 Received: July 26, 2018

Dear Shelly Harris:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

{1}------------------------------------------------

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for

Uwe Scherf, Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K182001

#### Sponsor/Applicant Name and Address 1.

| Company Name: | Sekisui Diagnostics, LLC |
|---------------|--------------------------------------------|
| Address: | 6659 Top Gun Street<br>San Diego, CA 92121 |

Telephone: [phone] Contact Person: Shelly Harris

Date Summary Prepared: 11/08/2018

#### 2. Device Name and Classification

Trade Name: Acucy™ Influenza A&B Test with the Acucy™ System Classification of Device: 21 CFR 866.3328, Influenza virus antigen detection test system Product Code: PSZ

#### 3. Predicate Device

K112177, K131606, K153012: Quidel Sofia® Analyzer and Influenza A+B FIA

#### 4. Device Description

### Operating Principle

The Acucy™ Influenza A&B Test is a lateral flow immunochromatographic assay in the sandwich immunoassay format. The Acucy Influenza A&B Test consists of a Test Cassette that detects and differentiates influenza A and influenza B viral antigens from a patient sample. The test sample, a nasal swab or nasopharyngeal swab, is processed to extract nucleoproteins by mixing the swab in Acucy Influenza A&B Extraction Buffer. The mixture is then added to the sample well of the Test Cassette. From there, the sample migrates along the membrane surface. If influenza A or B viral antigens are present, they form a complex with mouse monoclonal antibodies to influenza A and/or B nucleoproteins conjugated to colloidal gold. The complex is then bound by a rat anti-influenza A and/or mouse anti-influenza B antibody coated on the nitrocellulose membrane.

{4}------------------------------------------------

The Acucy Reader is an optoelectronic instrument that uses a reflectance-based measurement method to evaluate the line signal intensities in the results window of the Test Cassette. The Reader scans the Test Cassette and measures the absorbance intensity by processing the results using method-specific algorithms. The Acucy Reader displays the test results POS (+), NEG (-), or INVALID on the screen. The results can also be automatically printed on the Acucy Printer if this option is selected.

# Acucy™ Influenza A&B Test Kit Contents

The Acucy Influenza A&B Test Kit contains all the materials needed to run a test, except for the Acucy Reader, which is provided separately. The Acucy Influenza Test Kit contains the following components:

- 25 Acucy Influenza A&B Test Cassettes (+ 2 for external quality control testing) ●
- 25 Sterile Nasal Swabs
- 25 Acucy Influenza A&B Extraction Buffer Vials (+ 2 for external quality control ● testing)
- 25 Extraction Buffer Vial Dropper Tips (+ 2 for external quality control testing)
- 1 Influenza A Positive Control Swab ●
- 1 Influenza B Positive Control Swab
- 1 Instructions for Use (IFU) ●
- 1 Quick Reference Guide (READ NOW and WALK AWAY/NORMAL Modes) ●
- 1 External Quality Control (QC) Quick Reference Guide
- 1 Acucy System Calibration Procedure Quick Reference Guide .
- . 1 Workstation

The Acucy Reader is provided with an Acucy Printer, power cords and adapters, paper roll, Acucy Calibration Device with case, USB Memory Drive, and System Manual.

#### 5. Indications for Use

The Acucy™ Influenza A&B Test for the rapid qualitative detection of influenza A and B is composed of 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 that is automatically analyzed on the Acucy Reader. The Acucy Influenza A&B Test 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 Cassette. The test is intended for use with the Acucy System as an aid in the diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viruses. Negative test results are presumptive and should 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.

{5}------------------------------------------------

Performance characteristics for influenza A were established during the 2017-2018 influenza season when influenza A/H3N2 and A/H1N1pdm09 were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.

If infection with a novel influenza A 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 state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

#### Comparison to Predicate Device 6.

The following table provides a comparison of the characteristics of the Acucy Influenza A&B Test with the Acucy System to the predicate device, the Quidel Sofia Analyzer and Influenza A+B FIA: K112177, K1131606, and K153012.

| Similarities | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | 510(k) Device:<br>Acucy™ Influenza A&B Test<br>with the Acucy™ System | Predicate Device:<br>Sofia® Analyzer and Influenza<br>A+B FIA<br>K112177 |
| Indications for Use | The Acucy™ Influenza A&B Test for the rapid qualitative detection of influenza A and B is composed of 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 that is automatically analyzed on the Acucy Reader. The Acucy Influenza A&B Test 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 intended for use with the Acucy System as an aid in the diagnosis of influenza A and B viral infections. The test is not intended for the detection of influenza C viruses. | The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it is recommended these results be confirmed by virus culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other management |
| Negative test results are<br>presumptive and should be<br>confirmed by viral culture or an<br>FDA-cleared influenza A and B<br>molecular assay. Negative test<br>results do not preclude influenza<br>viral infection and should not be<br>used as the sole basis for<br>treatment or other patient<br>management decisions.<br><br>Performance characteristics for<br>influenza A were established<br>during the 2017-2018 influenza<br>season when influenza A/H3N2<br>and A/H1N1pdm09 were the<br>predominant influenza A viruses<br>in circulation. When other<br>influenza A viruses are<br>emerging, performance<br>characteristics may vary.<br><br>If infection with a novel<br>influenza A virus is suspected<br>based on current clinical and<br>epidemiological screening<br>criteria recommended by public<br>health authorities, specimens<br>should be collected with<br>appropriate infection control<br>precautions for novel virulent<br>influenza viruses and sent to<br>state or local health department<br>for testing. Viral culture should<br>not be attempted in these cases<br>unless a BSL 3+ facility is<br>available to receive and culture<br>specimens. | decisions. The test is intended<br>for professional and laboratory<br>use.<br><br>Performance characteristics for<br>influenza A and B were<br>established during February<br>through March 2011 when<br>influenza viruses<br>A/California/7//2009 (2009<br>H1N1), A/Perth/16/2009<br>(H3N2), and B/Brisbane/60/2008<br>(Victoria-Like) were the<br>predominant influenza viruses in<br>circulation according to the<br>Morbidity and Mortality Weekly<br>Report from the CDC entitled<br>"Update: Influenza Activity –<br>United States, 2010-2011<br>Season, and Composition of the<br>201102012 Influenza Vaccine".<br>Performance characteristics may<br>vary against other emerging<br>influenza viruses.<br><br>If infection with a novel<br>influenza virus is suspected<br>based on current clinical and<br>epidemiological screening<br>criteria recommended by public<br>health authorities, specimens<br>should be collected with<br>appropriate infection control<br>precautions for novel virulent<br>influenza viruses and sent to<br>state or local health department<br>for testing. Virus culture should<br>not be attempted in these cases<br>unless a BSL 3+ facility is<br>available to receive and culture<br>specimens. | |
| Assay Results | Qualitative | Same |
| Assay Targets | Influenza A and B antigens | Same |
| Assay Format | Lateral flow test cassette | Same |
| Sample Types | Nasal swab; nasopharyngeal<br>swab | Nasal swab, nasopharyngeal<br>swab; nasopharyngeal<br>aspirate/wash |
| Assay<br>Antibodies | Monoclonal antibodies to<br>influenza A and B<br>nucleoproteins | Same |
| Sample Transfer<br>Method | Dropper tip applied to extraction<br>tube to transfer extracted sample | Fixed volume pipet used to<br>transfer extracted sample |
| Reporting of<br>Results | Reader displays results on<br>screen; or may be printed | Same |
| Time to Result | 15 minutes | Same |
| Instrument<br>Modes | Read Now or Walk<br>Away/Normal | Same |
| Intended Users<br>and Use<br>Locations | Clinical laboratory and point of<br>care | Same |
| Calibrator | Yes - QC verification cassette<br>provided | Yes - Calibration cassette and<br>QC card provided |
| Storage<br>Temperature | Room Temperature | Same |
| Assay Controls | Internal procedural control | Same |
| Instrument<br>Quality Control<br>Features | Scanning procedural control<br>zone for adequate flow<br>•<br>Reader prevents use of used<br>cassettes<br>•<br>Reader prevents use of<br>expired cassettes<br>•<br>Prevents improper cassette<br>insertion<br>• | Same |
| Test Principle | Immunochromatographic device | Immunofluorescence device |
| Instrument<br>Detection<br>Method | Absorbance | Fluorescence |
| External<br>Controls | • Influenza A Positive/B<br>Negative Control<br>• Influenza B Positive/A<br>Negative Control | • Positive Influenza<br>A/Influenza B Control<br>• Negative Control |

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

#### 7. Performance Summary

# Expected Values

The prevalence of influenza varies from year to year, with outbreaks occurring during the fall and winter months. The influenza positivity rate is dependent upon many factors, including specimen collection, test method, and geographic location. Prevalence varies throughout the influenza season and from location to location.

The Sekisui Diagnostics prospective clinical study was conducted during the 2017-2018 influenza season. The following tables show the positivity rates of influenza A and influenza B as determined by the Acucy Influenza A&B Test in three subject age categories in that clinical study. The overall positivity rate observed during the 2017-2018 U.S. clinical study, based on 1003 evaluable nasal or nasopharyngeal swab samples, was 24.6% for influenza A and 14.6% for influenza B.

|…