Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard immunochromatographic assay with visual interpretation of colored lines. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML.

Therapeutic

No

This device is for diagnosis (detection of influenza virus antigens), not treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use as an aid in the rapid differential diagnosis of acute influenza type A and B viral infections."

SaMD (Software as a Medical Device)

No

The device is an immunochromatographic assay, which is a physical test strip that uses chemical reactions to detect antigens. It is not software.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device 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 term "in vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
Device Description: The description details how the test works by analyzing a biological sample (nasopharyngeal swab specimen) outside of the patient's body to detect specific antigens.
Performance Studies: The document describes performance studies conducted to evaluate the device's ability to accurately detect influenza antigens in collected samples. This is a standard requirement for IVDs to demonstrate their analytical and clinical performance.
Key Metrics: The document provides key metrics like Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA), which are used to assess the performance of diagnostic tests.

All of these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

PSZ

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 purple-colored 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 purple-colored 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

nasopharyngeal swab specimens

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription use
Point-of-Care investigational sites

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Prospective Clinical Study:
Sample Size: 944 nasopharyngeal swab specimens were considered evaluable out of 955 subjects enrolled.
Data Source: Multi-site prospective study during the 2018-2019 influenza season in the U.S. A total of 10 Point-of-Care investigational sites throughout the U.S. participated in the study. Patients presented with flu-like symptoms and met inclusion/exclusion criteria.
Annotation Protocol: Two nasopharyngeal swabs were collected from one nostril from each subject. The first swab was eluted in 3 ml of viral transport media and transported to a central laboratory for testing using an FDA-cleared molecular assay as a comparator method. The second swab was tested directly on CareStart™ Flu A&B Plus according to product instructions. Discrepant results were investigated by testing using an alternative FDA-cleared molecular assay at the same central laboratory.

Retrospective Study:
Sample Size: 162 swab samples (112 positive for influenza B and 50 negative) prepared from archived respiratory specimens.
Data Source: Archived respiratory specimens obtained from patients with influenza-like symptoms, confirmed positive or negative by an FDA-cleared molecular assay for influenza A and influenza B. These swab samples were distributed (blinded and randomized) among four investigational sites and tested during the prospective clinical study period.
Annotation Protocol: Not explicitly stated beyond being tested blinded and randomized, and incorporated into daily workflow.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Sensitivity: Limit of Detection (LoD)

Study Type: Analytical study.
Sample Size: 20 replicates for each virus strain.
Key Results: Determined LoD for various influenza A and B strains. All strains showed 95% or 100% reactivity at their determined LoD concentrations.
- Influenza A (H3N2) A/Perth/16/2009: 3.2 x 10^4.9^ EID50/ml, 100% (20/20)
- Influenza A (H3N2) A/Singapore/INFIMH-16-0019/2016: 2.0 x 10^5.2^ EID50/ml, 100% (20/20)
- Influenza A (H1N1) pdm09 A/California/07/2009: 3.2 x 10^4.9^ EID50/ml, 100% (20/20)
- Influenza A (H1N1) pdm09 A/Michigan/45/2015: 3.2 x 10^4.2^ EID50/ml, 100% (20/20)
- Influenza B (Victoria lineage) B/Brisbane/60/2008: 2.0 x 10^5.5^ EID50/ml, 95% (19/20)
- Influenza B (Victoria lineage) B/Colorado/06/2017: 1.6 x 10^6.4^ EID50/ml, 100% (20/20)
- Influenza B (Yamagata lineage) B/Wisconsin/01/2010: 4.0 x 10^4.9^ EID50/ml, 100% (20/20)
- Influenza B (Yamagata lineage) B/Phuket/3073/2013: 1.6 x 10^5.5^ EID50/ml, 100% (20/20)

Analytical Sensitivity: Reactivity (Inclusivity)

Study Type: Analytical study.
Sample Size: Not explicitly stated as a single number, but 15 strains of influenza A (3 replicates each) and 10 strains of influenza B (3 replicates each) were tested.
Key Results: All viruses were detected in all three replicates at the tested concentrations.

Analytical Specificity: Cross-Reactivity (Exclusivity) and Microbial Interference

Study Type: Analytical study.
Sample Size: 31 bacteria (3 replicates each, with and without influenza virus) and 15 non-influenza viruses (3 replicates each, with and without influenza virus).
Key Results: No cross-reactivity with common organisms was observed in influenza negative samples. No microbial interference was observed in samples with influenza A or B. All influenza negative samples tested negative, and all influenza positive samples tested positive.

Analytical Specificity: Interfering Substances Effect

Study Type: Analytical study.
Sample Size: 30 substances (3 replicates for each substance, with 4 influenza strains and negative samples).
Key Results: None of the thirty potential interfering substances tested produced false positive or false negative test results with influenza positive and negative samples at the specified concentrations, except for biotin. Biotin concentrations > 500 ng/ml can cause false negative influenza A results.

Prospective Clinical Study

Study Type: Clinical study.
Sample Size: 944 evaluable nasopharyngeal swab specimens.
Key Results:
- Influenza A Performance:
  - Positive Percent Agreement (PPA): 79.9% (95% CI: 75.7% – 83.7%)
  - Negative Percent Agreement (NPA): 98.4% (95% CI: 97.0% – 99.2%)
- Influenza B Performance:
  - Positive Percent Agreement (PPA): 88.2% (95% CI: 65.7% – 96.7%)
  - Negative Percent Agreement (NPA): 100.0% (95% CI: 99.6% – 100.0%)

Retrospective Study (supplemental for Influenza B)

Study Type: Clinical study.
Sample Size: 162 swab specimens (117 positive, 45 negative).
Key Results:
- Influenza B Performance:
  - Positive Percent Agreement (PPA): 96.6% (95% CI: 91.5% – 98.7%)
  - Negative Percent Agreement (NPA): 97.8% (95% CI: 88.4% – 99.6%)

Reproducibility Study

Study Type: Reproducibility study.
Sample Size: 7 sample categories, tested by 3 operators at 3 sites on 5 non-consecutive days (Total 135 replicates per sample category per site).
Key Results: Agreement of obtained results with expected results was 100% across all sites, operators, and days, for all sample categories, with 95% CI ranging from 97.2% to 100.0%.

Lot-to-Lot Precision

Study Type: Precision study.
Sample Size: 3 different lots of the device, with 9 replicates per sample category per lot.
Key Results: Agreement of observed results with expected results was 100%, and no variability was observed between reagent lots.
- Overall % Agreement and 95% CI: 100% (27/27) (87.5% - 100%) for all sample categories.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Prospective Clinical Study (versus Molecular Comparator):

Influenza A:
- Positive Percent Agreement (PPA): 79.9% (95% CI: 75.7% – 83.7%)
- Negative Percent Agreement (NPA): 98.4% (95% CI: 97.0% – 99.2%)
Influenza B:
- Positive Percent Agreement (PPA): 88.2% (95% CI: 65.7% – 96.7%)
- Negative Percent Agreement (NPA): 100.0% (95% CI: 99.6% – 100.0%)

Retrospective Study (Influenza B, versus Molecular Comparator):

Positive Percent Agreement (PPA): 96.6% (95% CI: 91.5% – 98.7%)
Negative Percent Agreement (NPA): 97.8% (95% CI: 88.4% – 99.6%)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K180438

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)
☑ 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: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

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

5.7. Product Contents

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Image /page/6/Picture/0 description: The image shows the logo for Access Bio, Inc. The logo includes a blue square with a flower design on the left side of the text. The text "Access Bio, Inc." is written in bold, black letters.

| Influenza Negative
control swab | 1 each | Influenza A negative and influenza B
negative external control swab.
Inactivated Group A, Streptococcus is dried
on the tip of the swab. |
|------------------------------------------------------|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Package insert | 1 each | Instructions for use |
| Quick Reference
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
for Rapid Detection of Flu A+B	CareStartTM Flu A&B Plus
510(k) Number	K180438	K191514
Regulation
Number	21 CFR 866.3328	Same
Regulation
Name	Influenza virus antigen detection
test system	Same
Regulatory
Class	Class II	Same
Product Code	PSZ	Same
Assay Target	Influenza A and B nucleoprotein
antigens	Same
	Predicate Device	Proposed Device
Contents	BD VeritorTM System
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.
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
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
	Predicate Device	Proposed Device
Contents	BD VeritorTM System
for Rapid Detection of Flu A+B
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. | CareStartTM Flu A&B Plus

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. |
| Specimens Type | Nasopharyngeal and
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
for Rapid Detection of Flu A+B | CareStart™ Flu A&B Plus |
| Detection
Format | An optoelectronic instrument
evaluates the line signal intensities
at each of the spatially defined test
and control line positions, interprets
the results using a scoring
algorithm, and reports a positive,
negative, or invalid result on the
LCD screen based on pre-set
thresholds. | Visual determination of presence or
absence of colored line indicators
for the test line and control line on
the test strip indicate the presence
of influenza A and/or B antigen. |
| Time to Result | 10 minutes | Same |
| Intended
environment for
use | Prescription use and CLIA waived | Prescription use |
| Storage
Condition | 2-30 °C | 1-30 °C |
| Controls | Kit Flu A+/B- dry swab procedural
control
Kit Flu B+/A- dry swab procedural
control
Internal positive control
Internal negative control | Influenza A positive control swab
Influenza B positive control swab
Influenza negative control swab
Internal positive control |

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Access Bio, Inc.

65 Clyde Rd. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

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Summary of Performance 5.9.

To verify and validate the device performance and characteristics, the following studies were conducted.

5.9.1. Analytical Sensitivity: Limit of Detection (LoD)

To determine the Limit of Detection (LoD) of CareStart™ Flu A&B Plus, four influenza A virus with two common currently or recently circulating influenza A subtypes (i.e.,

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Access Bio, Inc.

H3N2, H1N1 pdm09) and four influenza B virus with two genetic lineages (i.e., Victoria lineage and Yamagata lineage) were tested in this study.

In this study, each influenza virus strain of the panel was serially diluted to the concentration at which at least one negative result was obtained from replicate testing. The estimated LoD for each virus strain was confirmed by testing twenty replicates. The results presented in the table below.

Influenza Virus			% Reactive (No. of positive / Total No. of Replicates)
Type/Subtype	Strain	LoD (EID50/ml)
A (H3N2)	A/Perth/16/2009	$3.2 x 10^{4.9}$	100% (20/20)
A (H3N2)	A/Singapore/INFIMH-16-0019/2016	$2.0 x 10^{5.2}$	100% (20/20)
A (H1N1) pdm09	A/California/07/2009	$3.2 x 10^{4.9}$	100% (20/20)
A (H1N1) pdm09	A/Michigan/45/2015	$3.2 x 10^{4.2}$	100% (20/20)
B (Victoria lineage)	B/Brisbane/60/2008	$2.0 x 10^{5.5}$	95% (19/20)
B (Victoria lineage)	B/Colorado/06/2017	$1.6 x 10^{6.4}$	100% (20/20)
B (Yamagata lineage)	B/Wisconsin/01/2010	$4.0 x 10^{4.9}$	100% (20/20)
B (Yamagata lineage)	B/Phuket/3073/2013	$1.6 x 10^{5.5}$	100% (20/20)

EID50= 50% Egg Infectious Dose

5.9.2. Analytical Sensitivity: Reactivity (Inclusivity)

To determine the detectability of CareStart™ Flu A&B Plus, fifteen strains of influenza A virus representing each of three common currently or recently circulating influenza A subtypes (i.e., H3N2, H3N2v, and H1N1 pdm09) and ten strains of influenza B virus representing each of two influenza B genetic lineages (i.e., Yamagata lineage and Victoria lineage) were tested in this study.

In this study, each influenza virus strain of the panel was serially diluted to the concentration at which at least one negative result was obtained from replicate testing. All viruses were detected in all three replicates at the concentrations shown below.

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| Influenza Virus | | Lowest Concentration
detected by
CareStart™ Flu A&B
Plus | Test Results
(# of positives /

of replicates) | |

|----------------------------|------------------- | Subtype | Virus Strain Name Result Result |
| | A/Alaska/232/2015 | | A/California/02/2014 | A (H3N2) | A/Hong Kong/4801/2014 | | A/Michigan/15/2014 | | A/Texas/71/2017 | | A/Indiana/08/2011 | A (H3N2)v | A/Minnesota/11/2010 | | A/Bangladesh/3002/2015 | | A/Dominican | | A/Iowa/53/2015 | A (H1N1)
pdm09 | A/Massachusetts/15/2013 | | A/Michigan/272/2017 | | A/New Hampshire/02/2010 | | A/South Carolina/2/2010 | | A/St. Petersburg/61/2015 | | B/New Jersey/1/2012 | | B/Colorado/6/2017 | B (Victoria
lineage) | B/Florida/78/2015 | | B/Hong Kong/286/2017 | | B/Maryland/15/2016 | | B/Guangdong-Liwan/1133/2014 | B
(Yamagata
lineage) | B/Massachusetts/2/2012 | | B/Phuket/3073/2013 | | B/Texas/06/2011 | | B/Utah/09/2014 -------------|-------------------------------------------------------------------|-------------------------------------------------------|-----------------|
| | Flu A
| Flu B
| 2.6 x 106 CEID50/ml | 3/3 | 0/3 |
| 5.8 x 102 TCID50/ml | 3/3 | 0/3 |
| 9.6 x 105 CEID50/ml | 3/3 | 0/3 |
| 9.3 x 104 FFU/ml | 3/3 | 0/3 |
| 9.3 x 104 FFU/ml | 3/3 | 0/3 |
| 8.1 x 102 TCID50/ml | 3/3 | 0/3 |
| 2.2 x 104 CEID50/ml | 3/3 | 0/3 |
| 1.3 x 105 CEID50/ml | 3/3 | 0/3 |
Republic/7293/2013 | 5.0 x 103 TCID50/ml | 3/3 | 0/3 |
| 2.9 x 106 CEID50/ml | 3/3 | 0/3 |
| 1.6 x 106 CEID50/ml | 3/3 | 0/3 |
| 9.6 x 103 TCID50/ml | 3/3 | 0/3 |
| 1.8 x 106 CEID50/ml | 3/3 | 0/3 |
| 2.5 x 105 CEID50/ml | 3/3 | 0/3 |
| 9.3 x 105 CEID50/ml | 3/3 | 0/3 |
| 8.8 x 104 TCID50/ml | 0/3 | 3/3 |
| 1.6 x 106 CEID50/ml | 0/3 | 3/3 |
| 1.7 x 106 CEID50/ml | 0/3 | 3/3 |
| 2.7 x 103 TCID50/ml | 0/3 | 3/3 |
| 1.3 x 103 TCID50/ml | 0/3 | 3/3 |
| 1.8 x 106 CEID50/ml | 0/3 | 3/3 |
| 1.0 x 107 CEID50/ml | 0/3 | 3/3 |
| 1.1 x 106 CEID50/ml | 0/3 | 3/3 |
| 6.2 x 106 CEID50/ml | 0/3 | 3/3 |
| 6.3 x 104 CEID50/ml | 0/3 | 3/3 |

CEID50= 50% Chicken Embryo Infectious Dose TCID50= 50% Tissue Culture Infectious Dose FFU= Focus Forming Assay Unit

Analytical Specificity: Cross-Reactivity (Exclusivity) and Microbial 5.9.3. Interference

The potential cross-reactivity (exclusivity) of a panel of common organisms was evaluated with influenza negative samples using the CareStart™ Flu A&B Plus.

12

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ss Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

Potential microbial interference was evaluated with samples containing influenza A or influenza B at approximately 2x LoD. A total of 31 bacteria were tested at a target concentration of approximately 107 cfu/ml with the exception of Mycoplasma pneumoniae, which was tested at a final concentration of 1.5 x 103 cfu/ml. The 15 non-influenza viruses were tested at concentrations between 105.86 and 104-2 TCIDsolml. All influenza negative samples gave negative results at the concentrations of the potentially cross-reactive common organisms tested showing no crossreactivity with CareStart™ Flu A&B Plus assay. All samples with influenza A or influenza B tested positive showing no microbial interference at the concentrations of the potentially interfering common organisms tested.

| Bacteria | ATCC# | Stock
Concentrati
on (cfu/ml) | Testing
Concentrati
on (cfu/ml) | Results of
triplicate
without
influenza
virus (# of
positives / #
of
replicates) | Results of
triplicate in
presence of
influenza A
virus
(# of
positives / #
of
replicates) | Results of
triplicate in
presence of
influenza B
virus
(# of
positives / #
of
replicates) |
|--------------------------------|-------|-------------------------------------|---------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Acinetobacter
calcoaceticus | 17902 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Bordetella pertussis | 9340 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Candida albicans | 11006 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Chlamydophila
pneumoniae | 53592 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Corynebacterium
diphtheriae | 296 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Enterococcus faecalis | 4079 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Escherichia coli | 26 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Gardnerella vaginalis | 14018 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Haemophilus
influenzae | 49144 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Klebsiella
pneumoniae | 33495 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Lactobacillus casei | 393 | 109 | 107 | 0/3 | 3/3 | 3/3 |
| Legionella
pneumophila | 33152 | 109 | 107 | 0/3 | 3/3 | 3/3 |

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Access Bio, Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

| Listeria

monocytogenes	7302	109	107	0/3	3/3	3/3
Moraxella catarrhalis	25238	109	107	0/3	3/3	3/3
Mycobacterium
tuberculosis	NR-
122	109	107	0/3	3/3	3/3
Mycoplasma
pneumoniae	29342	1.5 x 105	1.5 x 103	0/3	3/3	3/3
Neisseria
gonorrhoeae	19424	109	107	0/3	3/3	3/3
Neisseria meningitidis	13077	109	107	0/3	3/3	3/3
Neisseria sicca	9913	109	107	0/3	3/3	3/3
Proteus vulgaris	33420	109	107	0/3	3/3	3/3
Pseudomonas
aeruginosa	9721	109	107	0/3	3/3	3/3
Staphylococcus
aureus	12600	109	107	0/3	3/3	3/3
Staphylococcus
epidermidis	14990	109	107	0/3	3/3	3/3
Serratia marcescens	13880	109	107	0/3	3/3	3/3
Streptococcus
mutans	25175	109	107	0/3	3/3	3/3
Streptococcus
pneumoniae	49136	109	107	0/3	3/3	3/3
Streptococcus
pyogenes	19615	109	107	0/3	3/3	3/3
Streptococcus sp.
Group B	12386	109	107	0/3	3/3	3/3
Streptococcus sp.
Group C	12388	109	107	0/3	3/3	3/3
Streptococcus sp.
Group F	700231	109	107	0/3	3/3	3/3
Streptococcus
sanguinis	10556	109	107	0/3	3/3	3/3

cfu/ml: colony-forming units per milliliter

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Access Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

| Viruses | ATCC# | Stock
Concentrati
on
(TCID50/ml) | Testing
Concentrati
on
(TCID50/ml) | Results of
triplicate
without
influenza
virus (# of
positives / #
of
replicates) | Results of
triplicate in
presence of
influenza A
virus
(# of
positives / #
of
replicates) | Results of
triplicate in
presence of
influenza B
virus
(# of
positives / #
of
replicates) |
|---------------------------------------|--------------|-------------------------------------------|---------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Adenovirus 1 | VR-1 | 107.20 | 105.20 | 0/3 | 3/3 | 3/3 |
| Adenovirus 7 | VR-7 | 106.45 | 105.45 | 0/3 | 3/3 | 3/3 |
| Coronavirus (OC43) | VR-
1558 | 105.45 | 105.45 | 0/3 | 3/3 | 3/3 |
| Coronavirus (229E) | VR-740 | 104.45 | 104.45 | 0/3 | 3/3 | 3/3 |
| Cytomegalovirus | VR-538 | 105.95 | 104.95 | 0/3 | 3/3 | 3/3 |
| Human
Coxsackievirus B4 | VR-184 | 107.45 | 105.45 | 0/3 | 3/3 | 3/3 |
| Human
metapneumovirus | NR-
22227 | 2.8 x 106 | 2.8 x 105 | 0/3 | 3/3 | 3/3 |
| Measles | VR-24 | 104.20 | 104.20 | 0/3 | 3/3 | 3/3 |
| Mumps (Enders) | VR-106 | 105.20 | 105.20 | 0/3 | 3/3 | 3/3 |
| Parainfluenza virus
type 1 | VR-94 | 107.86 | 105.86 | 0/3 | 3/3 | 3/3 |
| Parainfluenza virus
type 2 | VR-92 | 107.20 | 105.20 | 0/3 | 3/3 | 3/3 |
| Parainfluenza virus
type 3 | VR-93 | 107.20 | 105.20 | 0/3 | 3/3 | 3/3 |
| Respiratory Syncytial
Virus Type B | VR-
1400 | 106.20 | 105.20 | 0/3 | 3/3 | 3/3 |
| Rhinovirus 1A | VR-
1559 | 107.20 | 105.20 | 0/3 | 3/3 | 3/3 |
| Rubella | VR-315 | 106.20 | 105.20 | 0/3 | 3/3 | 3/3 |

TCID50= 50% Tissue Culture Infectious Dose

5.9.4. Analytical Specificity: Interfering Substances Effect

To assess the potential interference effects, the CareStart™ Flu A&B Plus was evaluated with thirty substances naturally or artificially present in the respiratory specimen or nasal cavity/nasopharynx.

The positive samples were prepared using the influenza A and B virus strains diluted to

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Access Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

a concentration approximately two times the respective LoD levels. Each influenza strain combined with each interfering substance was evaluated separately. Negative samples were prepared by adding each interfering substance to the Universal Transport Medium (UTM). Each positive and negative sample, combined with each interfering substance, was tested in triplicate. None of the thirty potential interfering substances tested produced false positive or false negative test results using CareStart™ Flu A&B Plus with influenza positive and negative samples at the concentrations specified below.

| Interfering
Substances | Concentra
tion Tested | Test Results (# of positives / # of replicates) | | | | |
|------------------------------|--------------------------|-------------------------------------------------|-------------------------|------------------------|------------------------|---------------------|
| | | A/Perth/1
6/2009 | A/Michigan
n/45/2015 | B/Colorad
o/06/2017 | B/Phuket/
3073/2013 | Negative
Samples |
| Acetaminophen | 10 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Acetyl salicylic
acid | 15 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Beclomethasone | 0.5 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Benzocaine | 5 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Budesonide | 2 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Chlorpheniramine
maleate | 5 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Dexamethasone | 1 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Dextromethorphan
HBr | 2 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Diphenhydramine
HCl | 5 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Ephedrine HCl | 10 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Flunisolide | 5 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Fluticasone | 1 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Guaiacol Glyceryl
Ether | 20 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |
| Histamine
Dihydrochloride | 10 mg/ml | 3/3 | 3/3 | 3/3 | 3/3 | 0/3 |

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Interfering	Concentra	Test Results (# of positives / # of replicates)
Substances	tion Tested	A/Perth/1
6/2009	A/Michigan
n/45/2015	B/Colorado/06/2017	B/Phuket/
3073/2013	Negative
Samples
Menthol	10 mg/ml	3/3	3/3	3/3	3/3	0/3
Mometasone	1 mg/ml	3/3	3/3	3/3	3/3	0/3
Mucin	2%	3/3	3/3	3/3	3/3	0/3
Mupirocin	1 mg/ml	3/3	3/3	3/3	3/3	0/3
OTC Throat drop
(Halls)	15%	3/3	3/3	3/3	3/3	0/3
OTC Throat drop
(Ricola)	15%	3/3	3/3	3/3	3/3	0/3
OTC Nasal spray
(Afrin)	15%	3/3	3/3	3/3	3/3	0/3
OTC Nasal spray
(Vicks Sinex)	15%	3/3	3/3	3/3	3/3	0/3
OTC Nasal spray
(Zicam)	15%	3/3	3/3	3/3	3/3	0/3
Oxymetazoline
HCl	10 mg/ml	3/3	3/3	3/3	3/3	0/3
Phenylephrine HCl	5 mg/ml	3/3	3/3	3/3	3/3	0/3
Phenylpropanolamine	5 mg/ml	3/3	3/3	3/3	3/3	0/3
Tobramycin	1 mg/ml	3/3	3/3	3/3	3/3	0/3
Triamcinolone	1 mg/ml	3/3	3/3	3/3	3/3	0/3
Whole Blood	2%	3/3	3/3	3/3	3/3	0/3
Zanamivir	1 mg/ml	3/3	3/3	3/3	3/3	0/3

The interfering effects of biotin concentrations ranging between 125 ng/mL and 2 µg/mL were tested in a separate study. Biotin concentrations up to 500 ng/ml did not lead to false results. Biotin concentrations >500 ng/ml can cause false negative influenza A results with the CareStart™ Flu A&B Plus.

17

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Access Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

5.9.5. 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 flu season and from location to location. The CareStart™ Flu A&B Plus prospective clinical study was conducted during the 2018-2019 influenza season. The following tables show the number of influenza A and influenza B positive cases and its percentage in four subject age categories, as observed during the clinical study.

| | Positivity Rates for Influenza A with the CareStartTM Flu A&B Plus
during the Clinical Study | | |
|--------------------|-------------------------------------------------------------------------------------------------|---------------------------------------|-----------------------------------|
| Age Group | Number of
Nasopharyngeal
Swab
Specimens | Number of
Influenza A
Positives | Influenza A
Positivity
Rate |
| ≤5 Years of Age | 174 | 61 | 35.1% |
| 6-21 Years of Age | 333 | 143 | 42.9% |
| 22-59 Years of Age | 394 | 101 | 25.6% |
| ≥60 Years of Age | 43 | 11 | 25.6% |
| Total | 944 | 316 | 33.5% |

	Positivity Rates for Influenza B with the CareStartTM Flu A&B Plus during the Clinical Study
Age Group	Number of Nasopharyngeal Swab Specimens	Number of Influenza B Positives	Influenza B Positivity Rate
≤5 Years of Age	174	2	1.1%
6-21 Years of Age	333	7	2.1%
22-59 Years of Age	394	5	1.3%
≥60 Years of Age	43	1	2.3%
Total	944	15	1.6%

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Image /page/18/Picture/1 description: The image shows a logo with a blue square shape. Inside the square, there are white shapes resembling the letters 'a', 'c', and '3'. A pink circle is positioned in the lower center of the square. A green stem with a leaf extends from the top of the square, adding a natural element to the design.

ss Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

5.9.6. Prospective Clinical Study

The clinical performance characteristics of CareStart™ Flu A&B Plus were evaluated in a multi-site prospective study during the 2018-2019 influenza season in the U.S. against an FDA-cleared influenza A and B molecular assay. A total of 10 Point-of-Care investigational sites throughout the U.S. participated in the study. To be enrolled in the study, patients had to be presenting at the participating study centers with flu-like symptoms and meet inclusion/exclusion criteria.

Two nasopharyngeal swabs were collected from one nostril from each subject using standard collection methods. At all sites, the first collected nasopharyngeal swab was eluted in 3 ml of viral transport media and transported to the central laboratory for testing using the FDA-cleared molecular assay as a comparator method. The second collected nasopharyngeal swab was tested directly on CareStart™ Flu A&B Plus according to product instructions.

A total of 955 subjects were enrolled in this study. Of those, 11 specimens are unevaluable (i.e., four samples failed to meet inclusion criteria, two samples were not collected due to subject refusal after enrollment, one sample was transported to the central laboratory in damaged and leaking state, and four samples transported to the central laboratory were mislabeled). A total of 944 nasopharyngeal swab specimens were considered evaluable. The performance of the CareStart™ Flu A&B Plus for influenza A and influenza B as compared to the comparator method is presented in the tables below.

All discrepant results were investigated by testing using an alternative FDA-cleared molecular assay at the same central laboratory. The results of this testing are captured in the footnotes but were not included in the calculations of the performance estimates shown below.

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Image /page/19/Picture/1 description: The image shows the logo for Access Bio, Inc. The logo includes a blue square with a flower design inside, and the text "Access Bio, Inc." is written in bold black letters next to it. Below the company name is the address "65 Clyde Rd, Suite A, Somerset, NJ".

CareStart™ Flu A&B Plus Influenza A Performance against the Comparator Method

| CareStartTM Flu A&B Plus –

Influenza A	Molecular Comparator
	Positive	Negative	Total
Positive	307	9a	316
Negative	77b	551	628
Total	384	560	944
Positive Percent Agreement (PPA)	79.9% (95% CI: 75.7% – 83.7%)
Negative Percent Agreement (NPA)	98.4% (95% CI: 97.0% – 99.2%)

a Influenza A was detected in 2/9 false positive specimens using an alternative FDA-cleared molecular influenza A/B assay

b Influenza A was not detected in 15/77 false negative specimens using an alternative FDA-cleared molecular influenza A/B assay

CareStart™ Flu A&B Plus Influenza B Performance against the Comparator Method

CareStart™ Flu A&B Plus -	Molecular Comparator
Influenza B	Positive	Negative	Total
Positive	15	0	15
Negative	2a	927	929
Total	17	927	944
Positive Percent Agreement (PPA)	88.2% (95% CI: 65.7% – 96.7%)
Negative Percent Agreement (NPA)	100.0% (95% CI: 99.6% – 100.0%)

a Influenza B was detected in 2/2 false negative specimens using an alternative FDA-cleared molecular influenza A/B assay

CareStart™ Flu A&B Plus Influenza A and B Performance against the Comparator Method (Percent Agreement) by Age Group

		Prospective Study during the 2018-2019 influenza season
		Influenza A	Influenza B
≤5 Years of Age	PPA	83.3% (55/66)
95% CI: 72.6% – 90.4%	100% (2/2)
95% CI: 34.2% – 100%
	NPA	94.4% (102/108)
95% CI: 88.4% – 97.4%	100% (172/172)
95% CI: 97.8% – 100%
6-21 Years of Age	PPA	82.5% (141/171)
95% CI: 76.1% - 87.4%	87.5% (7/8)
95% CI: 52.9% – 97.8%
	NPA	98.8% (160/162)
95% CI: 95.6% – 99.7%	100% (325/325)
95% CI: 98.8% – 100%
22-59 Years of Age	PPA	74.1% (100/135)
95% CI: 66.1% - 80.7%	83.3% (5/6)
95% CI: 43.7% - 97.0%

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ccess Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 Il Tel: (732)-873-4040 Il Fax: (732)-873-4043 Il info@accessbio.net

	NPA
	NPA	99.6% (258/259)
95% CI: 97.8% – 99.9%	100% (388/388)
95% CI: 99.0% – 100%
≥60 Years of Age	PPA	91.7% (11/12)
95% CI: 64.6% – 98.5%	100% (1/1)
95% CI: 20.7% – 100%
	NPA	100% (31/31)
95% CI: 89.0% – 100%	100% (42/42)
95% CI: 91.6% – 100%

5.9.7. Retrospective Study

Due to extremely low prevalence of influenza B observed during the 2018-2019 influenza season in the U.S., the prospective clinical study performance data were supplemented with data from a retrospective study testing 162 swab samples prepared from archived respiratory specimens that were obtained from patients with influenzalike symptoms and were confirmed positive or negative by an FDA-cleared molecular assay for influenza A and influenza B. These swab samples (112 samples positive for influenza B and 50 neqative samples) were distributed (blinded and randomized) among four of the investigational sites and the testing was incorporated into the daily workflow at each site during the prospective clinical study period.

All of the 162 swab specimens enrolled in the retrospective study were considered evaluable to supplement the prospective clinical performance data for influenza B. The performance of the CareStart™ Flu A&B Plus for influenza B with archived samples as compared to the FDA-cleared molecular method is presented in the table below.

CareStart™ Flu A&B Plus Influenza B (swab specimens prepared from frozen archived respiratory specimens) Performance against the Comparator Method

| CareStart™ Flu A&B Plus – Influenza B
(swab specimens prepared from frozen archived

respiratory specimens)	Molecular Comparator
	Positive	Negative	Total
Positive	113	1	114
Negative	4	44	48
Total	117	45	162
Positive Percent Agreement (PPA)	96.6% (95% CI: 91.5% – 98.7%)
Negative Percent Agreement (NPA)	97.8% (95% CI: 88.4% – 99.6%)

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Image /page/21/Picture/1 description: The image shows a logo with a blue square shape. Inside the square, there is a stylized flower with a pink center and white petals. Above the square, there is a green stem and leaf, suggesting a natural or organic theme. The logo appears to be for a brand or organization associated with nature, flowers, or possibly a product related to these elements.

ss Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

Reproducibility Study 5.9.8. -

The reproducibility study was performed to evaluate the reproducibility of the CareStart™ Flu A&B Plus with contrived swab samples at three Point-of-Care sites in the U.S. The test sample panels consisted of seven samples at various virus concentrations including near the respective LoD (i.e., true negative, high negative influenza A, low positive influenza A, moderate positive influenza A, high negative influenza B, low positive influenza B, and moderate positive influenza B). The sample panel was tested in a blinded manner by three operators at each of three test sites on five non-consecutive days. Agreement of obtained results with expected results was 100% across all sites, operators, and days.

	Site 1		Site 2		Site 3		Overall % Agreement and 95% CI
Sample Category	%	Count	%	Count	%	Count
True Negativea (no virus)	100.0%	45/45	100.0%	45/45	100.0%	45/45	100.0% (135/135) (97.2% - 100.0%)
High Negative Aa (0.1x LoD)	100.0%	45/45	100.0%	45/45	100.0%	45/45	100.0% (135/135) (97.2% - 100.0%)
Low Positive A (1x LoD)	100.0%	45/45	100.0%	45/45	100.0%	45/45	100.0% (135/135) (97.2% - 100.0%)
Moderate Positive A (3x LoD)	100.0%	45/45	100.0%	45/45	100.0%	45/45	100.0% (135/135) (97.2% - 100.0%)
High Negative Ba (0.1x LoD)	100.0%	45/45	100.0%	45/45	100.0%	45/45	100.0% (135/135) (97.2% - 100.0%)
Low Positive B (1x LoD)	100.0%	45/45	100.0%	45/45	100.0%	45/45	100.0% (135/135) (97.2% - 100.0%)
Moderate Positive B (3x LoD)	100.0%	45/45	100.0%	45/45	100.0%	45/45	100.0% (135/135) (97.2% - 100.0%)

Reproducibility by Study Site

a The expected results for true negative and high negative samples are negative results.

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Access Bio. Inc.

65 Clyde Rd. Suite A. Somerset, NJ 08873 II Tel: (732)-873-4040 II Fax: (732)-873-4043 II info@accessbio.net

5.9.9. Lot-to-Lot Precision

Three different lots of the CareStart™ Flu A&B Plus were evaluated for precision. Agreement of observed results with expected results was 100%. No variability was observed between reagent lots.

Sample Category	Reagent Lot 1		Reagent Lot 2		Reagent Lot 3		Overall % Agreement and 95% CI
	%	Count	%	Count	%	Count
True Negativea
(no virus)	100%	9/9	100%	9/9	100%	9/9	100% (27/27)
(87.5% - 100%)
High Negative Aa
(0.1x LoD)	100%	9/9	100%	9/9	100%	9/9	100% (27/27)
(87.5% - 100%)
Low Positive A
(1x LoD)	100%	9/9	100%	9/9	100%	9/9	100% (27/27)
(87.5% - 100%)
Moderate Positive A
(3x LoD)	100%	9/9	100%	9/9	100%	9/9	100% (27/27)
(87.5% - 100%)
High Negative Ba
(0.1x LoD)	100%	9/9	100%	9/9	100%	9/9	100% (27/27)
(87.5% - 100%)
Low Positive B
(1x LoD)	100%	9/9	100%	9/9	100%	9/9	100% (27/27)
(87.5% - 100%)
Moderate Positive B
(3x LoD)	100%	9/9	100%	9/9	100%	9/9	100% (27/27)
(87.5% - 100%)

a The expected results for true negative and high negative samples are negative results.

5.10. Conclusion

Based on the data submitted in this traditional 510(k) submission, the CareStart™ Flu A&B Plus has been shown to be substantially equivalent in terms of intended use, technological characteristics, and assay performance to the predicate device.