CareStart Flu A&B Plus

K191514 · Access Bio, Inc. · PSZ · Feb 18, 2020 · Microbiology

Device Facts

• Record ID: K191514
• Device Name: CareStart Flu A&B Plus
• Applicant: Access Bio, Inc.
• Product Code: PSZ · Microbiology
• Decision Date: Feb 18, 2020
• Decision: SESE
• Submission Type: Dual Track
• Regulation: 21 CFR 866.3328
• Device Class: Class 2

Intended Use

The CareStart™ Flu A&B Plus is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza virus type A and B nucleoprotein antigens directly from nasopharyngeal swab specimens of symptomatic patients. The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and B viral infections. This test is intended to distinguish between influenza type A and/or B virus in a single test. This test is not intended to detect influenza type C viral antigens. Negative test results are presumptive and should be confirmed by viral 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 basis for treatment or other patient management decisions. Performance characteristics for influenza A and B were established during the 2018-2019 influenza season when influenza A/H3N2, A/H1N1pdm09, and B/Victoria were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary. 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. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to received and culture specimens.

Device Story

CareStart Flu A&B Plus is a rapid immunochromatographic lateral flow assay for qualitative detection of influenza A and B nucleoprotein antigens. Input: nasopharyngeal swab specimen eluted in extraction buffer. Process: extracted sample migrates through test strip; viral antigens bind to anti-influenza antibodies conjugated to indicator particles; immune complexes captured by test lines. Output: visual interpretation of colored lines (red for Flu A, blue for Flu B, purple for control) at 10 minutes. Used in clinical settings by healthcare providers. Provides rapid differential diagnosis to aid clinical decision-making; negative results require confirmatory molecular testing.

Clinical Evidence

Prospective multi-site clinical study (n=944 evaluable) compared device to FDA-cleared molecular assay. Influenza A: 79.9% PPA, 98.4% NPA. Influenza B: 88.2% PPA, 100% NPA. Retrospective study (n=162) supplemented Influenza B data: 96.6% PPA, 97.8% NPA. Reproducibility and lot-to-lot precision studies showed 100% agreement.

Technological Characteristics

Immunochromatographic lateral flow assay. Materials: test cassette with strip, extraction vials, swabs. Principle: antigen-antibody binding with indicator particles. Visual readout. No electronic components. Storage: 1-30°C. Includes internal control line and external positive/negative control swabs.

Indications for Use

Indicated for symptomatic patients requiring rapid differential diagnosis of acute influenza type A and B viral infections via nasopharyngeal swab specimens. Not for detection of influenza C. 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

• BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (K180438)

Submission Summary (Full Text)

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February 18, 2020

Access Bio, Inc. Jongrak Kim Department General Manager, Regulatory Affairs 65 Clyde Road, Suite A. Somerset, New Jersey 08873

Re: K191514

Trade/Device Name: CareStart Flu A&B Plus Regulation Number: 21 CFR 866.3328 Regulation Name: Influenza Virus Antigen Detection Test System Regulatory Class: Class II Product Code: PSZ Dated: Nov 20, 2019 Received: Nov 21, 2019

Dear Jongrak Kim:

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

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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Steven Gitterman, M.D., Ph.D. Deputy Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K191514

Device Name CareStart™ Flu A&B Plus

#### Indications for Use (Describe)

The CareStart™ Flu A&B Plus is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza virus type A and B nucleoprotein antigens directly from nasopharyngeal swab specimens of symptomatic patients.

The test is intended for use as an aid in the rapid differential diagnosis of acute influenza type A and B viral infections. This test is intended to distinguish between influenza type A and/or B virus in a single test. This test is not intended to detect influenza type C viral antigens. Negative test results are presumptive and should be confirmed by viral 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 basis for treatment or other patient management decisions.

Performance characteristics for influenza A and B were established during the 2018-2019 influenza season when influenza A/H3N2, A/H1N1pdm09, and B/Victoria were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary.

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. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to received and culture specimens.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------|
| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Access Bio, Inc. The logo includes a blue square with a flower design and a green stem. The text "Access Bio, Inc." is written in bold, black letters, and the address "65 Clyde Rd, Suite A, Somerset, NJ 08873" is written below the company name.

# Section 5. 510(k) Summary of Safety and Effectiveness

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

The assigned 510(k) number is: K191514

#### 5.1. Submitter

- Company Name: Access Bio Incorporate -
- Address: 65 Clyde Road, Suite A, Somerset, NJ 08873 -
- Phone Number: -1-732-873-4040
- Fax Number: 1-732-873-4043 -
- FDA Registration Number: -3003966368

#### 5.2. Contact Person

- -Jongrak Kim / Manager, Regulatory Affairs Division
- Sang Joon Han / Manager, Research and Development Division -

#### 5.3. Device Information

- -Trade Name: CareStart™ Flu A&B Plus -Common Name: Influenza virus antigen detection test system
- -Device Class: Class II under 21 CFR 866.3328
- Devices Detecting Influenza A and B Virus -Classification Name: Antigens
- Product Code: -PSZ

#### 5.4. Predicate Device

- BD Veritor™ System for Rapid Detection of Flu A -Device Name: + B CLIA waived Kit -510(k) Number: K180438 - Manufacturer: Becton, Dickinson and Company

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Image /page/4/Picture/1 description: The image shows the logo of Access Bio, Inc. The logo includes a blue square with a flower design inside. The text "Access Bio, Inc." is written in bold, black letters. Below the company name is the address, which is "65 Clyde Rd, Suite A, Somerset".

#### 5.5. Device Description

The CareStart™ Flu A&B Plus test is an immunochromatographic assay for detection of extracted influenza type A and B virus nucleoprotein antigens in nasopharyngeal specimens.

Nasopharyngeal swabs require a sample preparation step in which the sample is eluted and washed off into the extraction buffer solution. Extracted swab sample is added to the sample well of the test device to initiate the test. When the swab sample migrates in the test strip, influenza A or B viral antigens bind to anti-influenza antibodies conjugated to indicator particles in the test strip forming an immune complex. The immune complex is then captured by each test line and control line on the membrane as it migrates through the strip.

Test results are interpreted at 10 minutes. The presence of two colored lines, a purplecolored line in the control region "C" and a red-colored line in the influenza A test region "A", indicates influenza A positive. The presence of two colored lines, a purplecolored line in the control region "C" and a blue-colored line in the influenza B test region "B", indicates influenza B positive. The presence of three colored lines, a purple-colored line in the control region "C", a red-colored line in the influenza A test region "A", and a blue-colored line in the influenza B test region "B indicates, influenza A and B dual positive result. The absence of a line on both influenza A and B test regions with a purple-colored line in the control region "C" indicates negative. No appearance of purple-colored line in the control region "C" indicates invalid test.

#### Intended Use / Indications for Use 5.6.

The CareStart™ Flu A&B Plus is an in vitro rapid immunochromatographic assay for the qualitative detection of influenza virus type A and B nucleoprotein antigens directly from nasopharyngeal swab specimens of symptomatic patients.

The test is intended for use as an aid in the rapid differential diagnosis of acute

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Image /page/5/Picture/1 description: The image shows a logo with a blue square as the background. A flower with a pink center and white petals is in the middle of the square. The number 3 is written on the top left of the flower. A green stem and leaf are attached to the top of the square.

ss Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: [phone] II Fax: [phone] II [e-mail]

influenza type A and B viral infections. This test is intended to distinguish between influenza type A and/or B virus in a single test. This test is not intended to detect influenza type C viral antigens. Negative test results are presumptive and should be confirmed by viral 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 basis for treatment or other patient management decisions.

Performance characteristics for influenza A and B were established during the 2018-2019 influenza season when influenza A/H3N2, A/H1N1pdm09, and B/Victoria were the predominant influenza viruses in circulation. When other influenza viruses are emerging, performance characteristics may vary.

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. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to received and culture specimens.

| Contents Name | Quantity<br>(in a kit) | Description |
|--------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Test device | 20 each | Foil pouched test device containing one test<br>strip which is encased on plastic device<br>cassette. |
| Extraction vial / cap | 20 vials and<br>caps | The extraction vial contains 400 µL extraction<br>buffer solution. |
| Nasopharyngeal swab | 20 each | Swab for nasopharyngeal specimen<br>collection. |
| Influenza A positive<br>control swab | 1 each | Influenza A positive and influenza B negative<br>external control swab.<br>Inactivated influenza A antigen is dried on the<br>tip of the swab. |
| Influenza B positive<br>control swab | 1 each | Influenza A negative and influenza B positive<br>external control swab.<br>Inactivated influenza B antigen is dried on<br>the tip of the swab. |

#### 5.7. Product Contents

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| Influenza Negative<br>control swab | 1 each | Influenza A negative and influenza B<br>negative external control swab.<br>Inactivated Group A, Streptococcus is dried<br>on the tip of the swab. |
|------------------------------------------------------|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Package insert | 1 each | Instructions for use |
| Quick Reference<br>Instructions (QRI) | 1 each | Quick reference instructions |
| The following materials are needed but not provided: | | |
| • Pair of gloves | • Timer / Pen | • Biohazard or sharps container |

#### 5.8. Comparison of Technological Characteristics with the Predicate Device

| Contents | Predicate Device | Proposed Device |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BD VeritorTM System<br>for Rapid Detection of Flu A+B | CareStartTM Flu A&B Plus |
| 510(k) Number | K180438 | K191514 |
| Regulation<br>Number | 21 CFR 866.3328 | Same |
| Regulation<br>Name | Influenza virus antigen detection<br>test system | Same |
| Regulatory<br>Class | Class II | Same |
| Product Code | PSZ | Same |
| Assay Target | Influenza A and B nucleoprotein<br>antigens | Same |
| | Predicate Device | Proposed Device |
| Contents | BD VeritorTM System<br>for Rapid Detection of Flu A+B | CareStartTM Flu A&B Plus |
| Intended Use | The BD VeritorTM 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 VeritorTM System for Rapid Detection of Flu A+B (also referred to as the BD VeritorTM System and BD VeritorTM 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.<br>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 | The CareStartTM Flu A&B Plus is an<br><i>in vitro</i> rapid<br>immunochromatographic assay for<br>the qualitative detection of influenza<br>virus type A and B nucleoprotein<br>antigens directly from<br>nasopharyngeal swab specimens of<br>symptomatic patients.<br>The test is intended for use as an<br>aid in the rapid differential diagnosis<br>of acute influenza type A and B viral<br>infections. This test is intended to<br>distinguish between influenza type<br>A and/or B virus in a single test.<br>This test is not intended to detect<br>influenza type C viral antigens.<br>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 results<br>do not preclude influenza virus<br>infections and should not be used<br>as the basis for treatment or other<br>patient management decisions.<br>Performance characteristics for<br>influenza A and B were established<br>during the 2018-2019 influenza<br>season when influenza A/H3N2,<br>A/H1N1pdm09, and B/Victoria were<br>the predominant influenza viruses in<br>circulation. When other influenza<br>viruses are emerging, performance<br>characteristics may vary.<br>If infection with a novel influenza<br>virus is suspected based on current<br>clinical and epidemiological<br>screening criteria recommended by<br>public health authorities, specimens<br>should be collected with appropriate<br>infection control precautions for |
| | Predicate Device | Proposed Device |
| Contents | BD VeritorTM System<br>for Rapid Detection of Flu A+B<br>and B/Yamagata lineage 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—United<br>States, 2010-2011 Season, and<br>Composition of the 2011-2012<br>Influenza Vaccine." Performance<br>characteristics may vary against<br>other emerging influenza viruses.<br><br>If infection with a novel influenza<br>virus is suspected based on current<br>clinical and epidemiological<br>screening criteria recommended by<br>public health authorities, specimens<br>should be collected with appropriate<br>infection control precautions for<br>novel virulent influenza viruses and<br>sent to the state or local health<br>department for testing. Virus culture<br>should not be attempted in these<br>cases unless a BSL 3+ facility is<br>available to receive and culture<br>specimens. | CareStartTM Flu A&B Plus<br><br>novel virulent influenza viruses and<br>sent to the state or local health<br>department for testing. Viral culture<br>should not be attempted in these<br>cases unless a BSL 3+ facility is<br>available to received and culture<br>specimens. |
| Specimens Type | Nasopharyngeal and<br>nasal swabs | Nasopharyngeal swabs |
| Assay Result | Qualitative | Same |
| Technology | Immunochromatographic assay | Same |
| Instrumentation | BD VeritorTM System Reader | None |
| | Predicate Device | Proposed Device |
| Contents | BD Veritor™ System<br>for Rapid Detection of Flu A+B | CareStart™ Flu A&B Plus |
| Detection<br>Format | An optoelectronic instrument<br>evaluates the line signal intensities<br>at each of the spatially defined test<br>and control line positions, interprets<br>the results using a scoring<br>algorithm, and reports a positive,<br>negative, or invalid result on the<br>LCD screen based on pre-set<br>thresholds. | Visual determination of presence or<br>absence of colored line indicators<br>for the test line and control line on<br>the test strip indicate the presence<br>of influenza A and/or B antigen. |
| Time to Result | 10 minutes…