← Product Code [SCA](/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA) · K243262

# QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test (K243262)

_Osang, LLC · SCA · Jan 13, 2025 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K243262

## Device Facts

- **Applicant:** Osang, LLC
- **Product Code:** [SCA](/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA.md)
- **Decision Date:** Jan 13, 2025
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3987
- **Device Class:** Class 2
- **Review Panel:** Microbiology
- **Attributes:** Pediatric

## Indications for Use

The QuickFinder™ COVID-19/Flu Antigen Self Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves or adults testing individuals aged 2 years or older. All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough, and/or shortness of breath, should seek follow up care from their healthcare provider. Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider for appropriate follow-up. The QuickFinder™ COVID-19/Flu Antigen Pro Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for use by individuals aged 14 years or older testing themselves or adults testing individuals aged 2 years or older. All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough, and/or shortness of breath, should seek follow up care from their healthcare provider. Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider for appropriate follow-up.

## Device Story

Lateral flow immunochromatographic assay for qualitative detection of SARS-CoV-2, influenza A, and influenza B antigens. Input: anterior nasal swab specimen eluted in extraction reagent. Principle: monoclonal antibodies bound to beads in conjugate pad bind viral antigens; complexes migrate to nitrocellulose membrane; captured by specific antibodies at test lines (S, A, B). Output: visual lines in results window indicating presence of specific viral antigens; control line (C) verifies reagent functionality and test performance. Used in home or clinical settings by lay users or professionals. Results interpreted visually by user after 15 minutes. Positive results indicate presence of detected virus; negative results are presumptive. Benefits include rapid, point-of-care differentiation of respiratory infections to guide clinical follow-up.

## Clinical Evidence

Prospective multi-center clinical study (N=788 symptomatic subjects). Comparator: highly sensitive RT-PCR. SARS-CoV-2 PPA: 90.6% (84.3-94.6% CI), NPA: 99.4% (98.5-99.8% CI). Flu A PPA: 89.7% (79.2-95.2% CI), NPA: 98.8% (97.7-99.4% CI). Flu B PPA: 86% (72.7-93.4% CI), NPA: 99.7% (99.0-99.9% CI). Usability study (N=50) showed 93% correct performance of critical tasks.

## Technological Characteristics

Lateral flow immunochromatographic assay. Components: plastic cassette, sample pad, conjugate pad (monoclonal antibodies on beads), nitrocellulose membrane (pre-coated with 3 test lines and 1 control line), absorbent pad. No biotin-streptavidin chemistry. Sterilization: Ethylene oxide (ISO 11135:2014). Standalone, non-instrumented, visually read.

## Regulatory Identification

A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.

## Predicate Devices

- Healgen Rapid Check COVID-19/Flu A&B Antigen Test ([DEN240029](/device/DEN240029.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

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FDA U.S. FOOD & DRUG ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I. Background Information:

A 510(k) Number
K243262

B Applicant
Osang LLC

C Proprietary and Established Names
QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

D Regulatory Information
|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  SCA | Class II | 21 CFR 866.3987 - Multi-Analyte Respiratory Virus Antigen Detection Test |   |

## II. Submission/Device Overview:

A Purpose for Submission:
To obtain 510(k) clearance for the QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test.

B Measurand:
Influenza type A and type B nucleoprotein and SARS-CoV-2 nucleocapsid antigens.

C Type of Test:
Qualitative Lateral flow Immunoassay

Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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III. Intended Use/Indications for Use:

A Intended Use(s):

Same as Indications for Use below.

B Indication(s) for Use:

QuickFinder COVID-19/Flu Antigen Self Test:

QuickFinder COVID-19/Flu Antigen Self Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

QuickFinder COVID-19/Flu Antigen Pro Test:

The QuickFinder COVID-19/Flu Antigen Pro Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

C Special Conditions for Use Statement(s):

OTC - Over The Counter

K243262 - Page 2 of 27

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D Special Instrument Requirements:

Not applicable.

E Device/System Characteristics:

1. Device Description:

The QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test (in the remainder of the document referred to as QuickFinder COVID-19/Flu Antigen Test) is an immunochromatographic assay that uses monoclonal antibodies to detect nucleoprotein antigens from SARS-CoV-2, influenza virus types A and B in anterior nasal swab (ANS) samples from symptomatic individuals. The test device is composed of a plastic housing, known as a cassette, that contains a test strip with the following parts: sample pad, conjugate pad, nitrocellulose membrane, and absorbent pad.

The test cassette contains a conjugate pad with anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies, and anti-influenza B nucleoprotein monoclonal antibodies bound to beads, and a nitrocellulose membrane that is pre-coated with 4 lines, three (3) test lines each containing monoclonal antibodies for one of the specific viral nucleoproteins for SARS-CoV-2, influenza A, and influenza B, and one (1) control line to verify that the test reagents are functional and the test was correctly performed.

The QuickFinder COVID-19/Flu Antigen Test is validated for testing direct samples without transport media. The QuickFinder COVID-19/Flu Antigen Test does not use biotin-Streptavidin/ avidin chemistry for any of the steps.

2. Principle of Operation:

To perform the test, an ANS specimen is collected from the patient and eluted into extraction reagent in the pre-filled vial, disrupting the virus particles and exposing internal viral nucleoproteins. After disruption, the swab is removed from the vial, and the extracted sample solution is transferred to the test cassette to allow the extracted specimen to flow onto the sample pad and migrate up the membrane of the test strip.

When the sample is applied to the sample well, the conjugate antibodies will bind any antigens in the sample to form complexes and migrate to the nitrocellulose membrane. The complexes will then be captured by coated antibodies on the membrane, and the test lines will form a visible line. The presence of SARS-CoV-2, influenza A and influenza B antigens are indicated by lines visible in the S-line position, A-line position, and B-line positions in the results window, respectively. For a valid test, the control C-line position must be visible on the test.

3. Interpretation of Results:

The qualitative results of the QuickFinder COVID-19/Flu Antigen Test are visually interpreted by the user. Examples of the positive, negative, and invalid results interpretations are provided within the "Interpretation of Results" section of the QRI.

Results interpretation is described in the figure below.

K243262 - Page 3 of 27

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K243262 - Page 4 of 27

|  Invalid (No Result) | If a control line is not visible at “C” after 15 minutes, even if any other line is visible in the results window, THE TEST HAS FAILED and is considered invalid.

DO NOT CONTINUE reading the results. Repeat the test with a new sample and new test kit materials.

STOP: If the test is invalid, repeat the test procedure using a new test kit and sample.

NOTE: The images are examples only; additional invalid outcomes are possible.

Complete set of invalid results can be found at http://www.osangllc.com/covid-19-flu-combo-self-testing  |
| --- | --- |
|  Negative Result | If the control line at 'C' is visible and you do not see a line at ‘S’, ‘B’, or ‘A’, the test is negative. It means you may not have COVID-19, Flu B or Flu A virus.

If you still have COVID-19, Flu B or Flu A symptoms, you should seek follow-up care with your healthcare provider.  |
|  Positive Result | If the control line at C is visible, and any other line or multiple lines on S, B and/or A appear, the test is positive.

This virus next to the positive line was detected in your sample.  |

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K243262 - Page 5 of 27

# IV. Substantial Equivalence Information:

## A Predicate Device Name(s):

Healgen Rapid Check COVID-19/Flu A&B Antigen Test

## B Predicate 510(k) Number(s):

DEN240029

## C Comparison with Predicate(s):

|  Device & Predicate Device(s): | K243262 | DEN240029  |
| --- | --- | --- |
|  Device Trade Name | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Healgen Rapid Check COVID-19/Flu A & B Antigen Test  |
|  General Device Characteristic Similarities  |   |   |
|  Intended Use | Same | Over-the-counter test to detect SARS-CoV-2 and Influenza A and B from clinical specimens.  |
|  Indications For Use | QuickFinder COVID-19/Flu Antigen Self Test:
The QuickFinder COVID-19/Flu Antigen Self Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection.
Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar.
This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience | The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection.
Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms,  |

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K243262 - Page 6 of 27
|  Device & Predicate Device(s): | K243262 | DEN240029  |
| --- | --- | --- |
|   | continued or worsening
respiratory symptoms, such as
fever, cough and/or shortness of
breath, should seek follow-up
care from their healthcare
provider.

Positive results do not rule out
co-infection with other
respiratory pathogens, and
therefore do not substitute for a
visit to a healthcare provider or
appropriate follow-up.

QuickFinder COVID-19/Flu
Antigen Pro Test:
The QuickFinder COVID-19/Flu
Antigen Pro Test is a lateral flow
immunochromatographic assay
intended for the qualitative
detection and differentiation of
influenza A, and influenza B
nucleoprotein antigens and
SARS-CoV-2 nucleocapsid
protein directly in anterior nasal
swab samples from individuals
with signs and symptoms of
respiratory tract infection.
Symptoms of respiratory
infections due to SARS-CoV-2
and influenza can be similar.
This test is for use by individuals
aged 14 years or older testing
themselves, or adults testing
individuals aged 2 years or older.

All negative results are
presumptive and should be
confirmed with an FDA-cleared
molecular assay when
determined to be appropriate by
a healthcare provider. Negative
results do not rule out infection
with influenza, SARS-CoV-2 or
other pathogens. Individuals who
test negative and experience
continued or worsening
respiratory symptoms, such as
fever, cough and/or shortness of
breath, should seek follow-up
care from their healthcare
provider. | such as fever, cough and/or
shortness of breath, should seek
follow-up care from their
healthcare provider.

Positive results do not rule out
co-infection with other
respiratory pathogens, and
therefore do not substitute for a
visit to a healthcare provider or
appropriate follow-up.  |

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K243262 - Page 7 of 27

|  Device & Predicate Device(s): | K243262 | DEN240029  |
| --- | --- | --- |
|   | Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up. |   |
|  Prescription Use / Over-the-Counter | Same | Over-the-Counter  |
|  End user | Same | Lay user  |
|  Environment of use | Same | Home or similar environment  |
|  Disease | Same | COVID-19 Influenza A and B  |
|  Intended use population | Same | Symptomatic individuals 14 years of age and older testing themselves and adults testing individuals aged 2 years and older.  |
|  Sample | Same | Anterior nasal swab specimen  |
|  Assay principle | Same | Lateral flow  |
|  Qualitative or quantitative | Same | Qualitative  |
|  Organism detected | Same | SARS-CoV-2 Influenza A and B  |
|  Format | Same | Test cassette  |
|  Controls | Same | Internal control  |
|  Time to result | Same | 15 minutes  |
|  Results | Same | Positive, negative, or invalid  |
|  Interpretation | Same | Visually read  |

V. Standards/Guidance Documents Referenced:

The following have been referenced for Conformity.

|  Document number | Title | Publishing Organization  |
| --- | --- | --- |
|  11135:2014 | Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices | ISO  |
|  109993-7 | Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals | ISO  |
|  10993-10:2010 | Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | ISO  |
|  10993-5:2009 | Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | ISO  |

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VI. Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision:

The Precision study for the QuickFinder COVID-19/Flu Antigen Test was evaluated in two different in-house studies using the same 3 lots. The strains used for testing were UV inactivated SARS-CoV-2: USA-WA1/2020, H1N1pdm09/A/Victoria/4897/2022, and Yamagata/B/Florida/4/2006.

Study 1 was conducted by 2 trained operators who each tested eight samples with different analyte concentrations and combinations (Negative, 2X LoD SARS-CoV-2, 2X LoD Flu A, 2X LoD Flu B, 2X LoD SARS-CoV-2 &Flu A co-spiked, 2X LoD SARS-CoV-2 &Flu B co-spiked, 2X LoD Flu A &Flu B co-spiked, 2X LoD SARS-CoV-2 &Flu A &Flu B co-spiked). All samples were formulated in negative clinical matrix, pooled nasal wash (PNW). Each operator tested two sample replicates each in 2 runs for each of 3 lots of devices. Runs were performed in the morning and afternoon (or at least 4 hours apart) over 10 days. This design (2 replicates/run/lot x 2 runs/operator x 2 operators x 3 lots x 10 days) resulted in 240 total replicates per sample. All samples were randomized and blinded for each day. Results for this study are shown in Table 1 below and were concordant with the expected results; that is, all samples with analyte produced positive results, and all samples without analyte produced negative results.

Table 1: Summary Results for Lot-to-Lot Precision Study (Operators 1 and 2 Combined)

|  Analyte in Sample | Analyte Test Lines | Lot 1 |   | Lot 2 |   | Lot 3 |   | Lot-to-Lot Agreement | 95% CI**  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Count | % Amt* | Count | % Amt | Count | % Amt  |   |   |
|  Negative | SARS-CoV-2 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu A | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu B | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|  SARS-CoV-2 | SARS-CoV-2 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu A | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu B | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|  Flu A | SARS-CoV-2 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu A | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu B | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|  Flu B | SARS-CoV-2 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu A | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu B | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|  SARS-CoV-2 + Flu A | SARS-CoV-2 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu A | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu B | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|  SARS-CoV-2 + | SARS-CoV-2 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu A | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |

K243262 - Page 8 of 27

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Study 2 was specifically conducted to assess between-lot variability. The study used negative samples (without virus analytes) and low positive samples at 0.75X LoD for all three analytes (0.75X LoD SARS-CoV-2 & Flu B Co-spike and 0.75X LOD Flu A). Samples were blinded and tested randomized. This supplemental precision testing was carried out over 3 days only, but otherwise followed the same study design as above. This resulted in 72 total tests per sample level (24 replicates for each analyte with each lot). Lot and operator stratified results from this testing are included in Table 2 below.

Precision estimates for samples below the LoD, the 0.75X LoD sample, are expected to be low due to the random errors of the testing procedure across different days and runs, paired with an operator's ability to read the line intensity for samples with very low analyte concentration.

Table 2: Summary for Supplemental Precision Study (0.75xLoD for positive samples)

|  Analyte in Sample | Analyte Test Lines | Lot 1 |   | Lot 2 |   | Lot 3 |   | Lot-to-Lot Agreement | 95% CI**  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Count | % Amt* | Count | % Amt | Count | % Amt  |   |   |
|  Flu B | Flu B | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|  Flu A + Flu B | SARS-CoV-2 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu A | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu B | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|  SARS-CoV-2 + Flu A + Flu B | SARS-CoV-2 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu A | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |
|   |  Flu B | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100%  |

*Amt = Agreement: Result matched expected result.
**95% CI = 2-sided 95% Confidence Interval

Table 2: Summary for Supplemental Precision Study (0.75xLoD for positive samples)

|  Analyte in Sample | Analyte Test Lines | Between Lot |   |   |   |   |   | Between Operator  |   |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  Lot 1 |   | Lot 2 |   | Lot 3 |   | Op-1 |   | Op-2  |   |
|   |   |  Count | % Amt* | Count | % Amt | Count | % Amt | Count | % Amt | Count | % Amt  |
|  Negative | SARS-CoV-2 | 24/24 | 100% | 24/24 | 100% | 24/24 | 100% | 36/36 | 36/36 | 36/36 | 36/36  |
|   |  Flu A | 24/24 | 100% | 24/24 | 100% | 24/24 | 100% | 36/36 | 36/36 | 36/36 | 36/36  |
|   |  Flu B | 24/24 | 100% | 24/24 | 100% | 24/24 | 100% | 36/36 | 36/36 | 36/36 | 36/36  |
|  SARS-CoV-2 + Flu B | SARS-CoV-2 | 18/24 | 75% | 14/24 | 58.3% | 17/24 | 70.8% | 25/36 | 69.4% | 24/36 | 66.7%  |
|   |  Flu A | N/A* | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A  |
|   |  Flu B | 19/24 | 79.2% | 13/24 | 54.2% | 18/24 | 75% | 24/36 | 66.7% | 26/36 | 72.2%  |
|  Flu A | SARS-CoV-2 | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A  |
|   |  Flu A | 15/14 | 62.5% | 23/24 | 95.8% | 17/24 | 70.8% | 29/36 | 80.6% | 26/36 | 72.2%  |
|   |  Flu B | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A  |

*Amt = Agreement: Result matched expected result.
**N/A: Not applicable because the analyte wasn't present in the tested sample and all tested replicates correctly returned negative results for these analytes (i.e., no false positive results were observed).

Taken together, the results of both precision assessments demonstrate a test precision and a lot-to-lot precision that are consistent with the expectations for the analyte concentrations in the

K243262 - Page 9 of 27

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samples, the test's technology, and the test's LoD. The between-lot variability does not impact low concentrated samples equal to or above  $2\mathrm{X}$  LoD of the test.

# 2. Linearity:

This is a qualitative test and linearity is not applicable.

# 3. Analytical Specificity/Interference:

# a. Cross Reactivity and Microbial Interference

Cross Reactivity and Microbial Interference studies were conducted to determine if other respiratory pathogens/flora that could be present in a direct nasal swab samples could cause a false-positive test result or interfere with a true positive result. A panel of viruses, bacteria, fungi, and pooled nasal wash (PNW) was used for these studies. Final organism concentrations were targeted to be at least  $1.0 \times 10^{5} \mathrm{PFU/mL}$  and  $/1 \times 10^{5} \mathrm{TCID}_{50} / \mathrm{mL}$  for viruses, and  $1.0 \times 10^{6} \mathrm{CFU/mL}$  for bacteria and fungi. Where this target concentration was not achievable due to the titer of the stock culture, the highest concentration possible was tested without dilution. Dilutions for cross-reactivity testing were made in pooled negative nasal swab matrix (swabs collected in saline). Each organism was tested in replicates of three (3) without SARS-CoV-2/ Flu A/Flu B present in the sample.

Organisms that did not cause a false-positive result were further evaluated for microbial interference by testing PNW spiked with low-level UV inactivated SARS-CoV-2, live Flu A virus, and live Flu B virus isolate (3X co-spike equivalency LoD) in the presence of potentially interfering organism at a high titer in triplicate.

Neither cross-reactivity nor interference was observed for any of the organisms at the concentrations tested with the QuickFinder COVID-19/Flu Antigen Test device.

The summary of cross-reactivity and microbial interference results are shown in the table below.

Table 3: Summary of Cross-Reactivity and Microbial Interference Results

|  Organism | Concentration Tested | Units | Cross-Reactivity | Microbial Interference  |
| --- | --- | --- | --- | --- |
|  SARS-CoV-1 | 1.25E+05 | PFU/mL | ND* | ND  |
|  MERS-coronavirus | 1.47E+05 | TCID50/mL | ND | ND  |
|  Human coronavirus OC43 | 7.00E+05 | TCID50/mL | ND | ND  |
|  Human coronavirus 229E | 1.58E+05 | TCID50/mL | ND | ND  |
|  Human coronavirus NL63 | 7.05E+04 | TCID50/mL | ND | ND  |
|  Human coronavirus HKU1 | 1.74E+07 | GE/mL | NA | ND  |
|  Adenovirus, Type 1 (Adenoid 71) | 2.23E+05 | TCID50/mL | ND | ND  |
|  Adenovirus Type 7, Type 7A (Species B) | 1.58E+05 | TCID50/mL | ND | ND  |
|  Cytomegalovirus, Strain AD-169 | 7.05E+04 | TCID50/mL | ND | ND  |
|  Epstein Barr Virus, Strain B95-8 | 1.83E+06 | CP/mL | ND | ND  |
|  Human Metapneumovirus (hMPV), Strain TN/91-316 | 3.50E+05 | TCID50/mL | ND | ND  |
|  Parainfluenza virus 1, Strain FRA/29221106/2009 | 2.00E+05 | TCID50/mL | ND | ND  |

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|  Organism | Concentration Tested | Units | Cross-Reactivity | Microbial Interference  |
| --- | --- | --- | --- | --- |
|  Parainfluenza virus 2, Strain Greer | 1.75E+05 | TCID50/mL | ND | ND  |
|  Parainfluenza virus 3, Strain C243 | 7.00E+05 | TCID50/mL | ND | ND  |
|  Parainfluenza virus 4, Strain N/A | 2.39E+05 | TCID50/mL | ND | ND  |
|  Enterovirus Species D Type 68 | 2.23E+05 | TCID50/mL | ND | ND  |
|  Respiratory syncytial virus A, Strain A-2 | 3.50E+05 | TCID50/mL | ND | ND  |
|  Respiratory syncytial virus B, Strain CH93(18)-18 | 2.29E+05 | TCID50/mL | ND | ND  |
|  Rhinovirus 1A, Strain N/A | 7.05E+04 | TCID50/mL | ND | ND  |
|  Bordetella pertussis, Strain A639 | 2.90E+08 | CFU/mL | ND | ND  |
|  Candida albicans, Strain Z006 | 1.21E+07 | CFU/mL | ND | ND  |
|  Chlamydophila pneumoniae, Strain Z500 | 4.33E+06 | IFU/mL | ND | ND  |
|  Corynebacterium xerosis | 2.30E+07 | CFU/mL | ND | ND  |
|  Escherichia coli, Strain mcr-1 | 1.79E+08 | CFU/mL | ND | ND  |
|  Hemophilus influenzae, type b; Eagan | 9.68E+06 | CFU/mL | ND | ND  |
|  Lactobacillus sp., Lactobacillus Acidophilus, Strain Z048 | 1.21E+07 | CFU/mL | ND | ND  |
|  Legionella spp pneumophila, Strain Philadelphia-1 | 6.50E+06 | CFU/mL | ND | ND  |
|  Moraxella catarrhalis, Strain 59632 | 2.50E+08 | CFU/mL | ND | ND  |
|  Mycoplasma pneumoniae, Strain PI 1428 | 2.50E+07 | CFU/mL | ND | ND  |
|  Mycobacterium tuberculosis avirulent, Strain H37Ra-1 | 3.03E+06 | CFU/mL | ND | ND  |
|  Neisseria meningitidis, serogroup A | 3.43E+06 | CFU/mL | ND | ND  |
|  Neisseria sp. Elongata Z071 | 2.68E+08 | CFU/mL | ND | ND  |
|  Pneumocystis jirovecii, Strain W303-Pji | 1.30E+07 | CFU/mL | ND | ND  |
|  Pseudomonas aeruginosa, Strain N/A | 3.45E+08 | CFU/mL | ND | ND  |
|  Staphylococcus aureus ssp aureus | 2.60E+08 | CFU/mL | ND | ND  |
|  Staphylococcus epidermidis (PCI 1200) | 9.00E+07 | CFU/mL | ND | ND  |
|  Streptococcus salivarius, Ssp salivarius | 1.01E+06 | CFU/mL | ND | ND  |
|  Streptococcus pneumoniae, Strain Z022 | 1.81E+07 | CFU/mL | ND | ND  |
|  Streptococcus pyogenes, Strain MGAS 8232 | 7.50E+07 | CFU/mL | ND | ND  |
|  Measles, Strain Edmonston | 8.48E+05 | TCID50/mL | ND | ND  |
|  Mumps (Isolate 1) | 8.48E+05 | TCID50/mL | ND | ND  |

*ND – Not Detected

# b. Competitive Interference:

Competitive interference of the test's analytes with each other was tested with different combinations of low (3x single analyte LoD) and high (1000X single analyte LoD or the highest achievable concentration) concentrations of Flu A, Flu B and SARS-CoV-2 spiked

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together into the same sample. Samples were tested with one lot of QuickFinder COVID-19/Flu Antigen Test device in three replicates per test condition. The study used UV inactivated SARS-CoV-2 but live influenza A and B virus strains; virus materials were spiked into negative clinical matrix (PNW).

The table below summarizes the results of the competitive interference study. For each condition tested all three replicates tested at the low target analyte condition tested positive in the presence of a second target analyte at high concentrations. No false positive results were observed for analytes that are not present in the sample.

Table 4: Competitive Interference Results Summary

|  SARS-CoV-2 (USA-WA1/2020) |   | Influenza A Virus (H1N1pdm09) A/Victoria/4897/2022 |   | Influenza B Virus (Yamagata Lineage) B/Florida/4/2006  |   |
| --- | --- | --- | --- | --- | --- |
|  Concentration | % Agreement | Concentration | % Agreement | Concentration | % Agreement  |
|  - | 100% | High | 100% | Low | 100%  |
|  Low | 100% | High | 100% | - | 100%  |
|  Low | 100% | High | 100% | Low | 100%  |
|  - | 100% | Low | 100% | High | 100%  |
|  Low | 100% | - | 100% | High | 100%  |
|  Low | 100% | Low | 100% | High | 100%  |
|  High | 100% | Low | 100% | - | 100%  |
|  High | 100% | - | 100% | Low | 100%  |
|  High | 100% | Low | 100% | Low | 100%  |

# c. Exogenous and Endogenous Interference Study

The QuickFinder COVID-19/Flu Antigen Test was also evaluated for performance in the presence and absence of potentially interfering substances that might be present in a respiratory specimen. Interfering substances testing was performed using a panel of endogenous and exogenous substances tested at concentrations listed in the below table.

Negative specimens were evaluated in triplicates to confirm that the potentially interfering substances would not cause false positive results with the test.

Negative clinical matrix (pooled nasal wash) was co-spiked with SARS-CoV-2 USA WA1/2020 (UV inactivated), Flu A H1N1 Victoria/4897/2022, and Flu B Yamagata/B/Florida/4/2006, and then mixed 1:1 with interfering substance. Final concentration for each analyte was 3X LoD based on the established co-spike LoD. Negative nasal wash (PNW) has been demonstrated to be equivalent to the pooled nasal swab matrix (PNSM) in a matrix equivalency study. Testing was performed in triplicates to confirm that SARS-CoV-2, Flu A and Flu B could still be detected if the test substances were present in the sample. All testing was randomized and blinded. Test results are summarized in the table below.

With the exception of Flu Mist Quadrivalent live influenza vaccine, none of the substances caused a false-positive test result in unspiked samples. While the presence of Flu Mist Quadrivalent live influenza vaccine at  $15\%$  v/v concentration did not interfere with the detection of true positive results of the 3X LoD co-spiked samples, the vaccine resulted in

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cross reactivity (positive results) for Flu A and Flu B, as expected based on the composition of the vaccine.

Hand soap liquid gel at  $10\%$  w/v showed false negative results for Flu B, but all analytes were detected when its concentration was at  $0.05\%$  w/v.

Table 5: Interfering Substances Study Results

|  Interfering Substance | Concentration | Cross-reactivity (no analyte) (# pos/ # total) |   |   | Interference (3X LoD analyte) (# pos/ # total)  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  SCV2 | Flu A | Flu B | SCV2 | Flu A | Flu B  |
|  Human Whole Blood (K2-EDTA) | 4% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Leukocytes | 2.85 x 10^6 cells/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Throat lozenges (Menthol/Benzocaine) | 3 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Mucin Type I-S bovine submaxillary glands | 2.5 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Zinc (Therazine throat Spray) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Naso GEL (NeilMed) | 5% | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal Drops (Phenylephrine) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal Spray (Oxymetazoline) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal Spray (Cromolyn) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal Spray (Saline) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal Corticosteroid (Triamcinolone) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal Corticosteroid (Dexamethasone) | 1 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal Corticosteroid (Fluticasone) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal gel (Galphimia glauca, Histanium hydrocloricum, Luffa operculata, Sulfur) | 1.25% | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Homeopathic allergy relief (Histaminum hydrochloricum) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Zicam nasal spray (Galphimia glauca, Luffa operculata) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Nasal spray (Alkalol) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Sore Throat Spray (Phenol) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Antibiotic (Tobramycin) | 4 μg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Antibiotic, nasal ointment (Mupirocin) | 10 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Anti-viral drug (Remdesvir) | 10 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Tamiflu (Oseltamivir phosphate) | 5 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|   | 15% v/v | 0/3 | 3/3 | 3/3 | 3/3 | 3/3 | 3/3  |

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|  Interfering Substance | Concentration | Cross-reactivity (no analyte) (# pos/ # total) |   |   | Interference (3X LoD analyte) (# pos/ # total)  |   |   |
| --- | --- | --- | --- | --- | --- | --- | --- |
|   |   |  SCV2 | Flu A | Flu B | SCV2 | Flu A | Flu B  |
|  FluMist (Quadrivalent/Live) | 6 % v/v | 0/3 | 3/3 | 3/3 | N/A | N/A | N/A  |
|   |  3% v/v | 0/3 | 3/3 | 3/3 | N/A | N/A | N/A  |
|   |  1.5 % v/v | 0/3 | 0/3 | 0/3 | N/A | N/A | N/A  |
|   |  0.75 % v/v | 0/3 | 0/3 | 0/3 | N/A | N/A | N/A  |
|  Zanamivir | 282 ng/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Biotin | 3500 ng/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Body & Hand Lotion | 0.5% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Body Lotion, with 1.2% dimethicone | 0.5% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Hand Lotion | 5% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Hand Sanitizer with Aloe, 62% ethyl alcohol | 5% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Hand Sanitizer cream lotion | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Hand Sanitizer, 80% ethanol, fast drying | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3  |
|  Hand soap liquid gel | 10% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 0/3  |
|   |  1 % w/v | N/A | N/A | N/A | 3/3 | 3/3 | 0/3  |
|   |  0.1 % w/v | N/A | N/A | N/A | 3/3 | 3/3 | 0/3  |
|   |  0.05 % w/v | N/A | N/A | N/A | 3/3 | 3/3 | 3/3  |
|   |  0.01 % w/v | N/A | N/A | N/A | 3/3 | 3/3 | 3/3  |

## 4. Assay Reportable Range:

This section is not applicable as this device is a qualitative assay.

## 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

### a. Controls

#### i. Internal Controls:

Both the test strips enclosed in the QuickFinder COVID-19/Flu Antigen Test device independently feature an internal control, denoted directly on the user interface of the test device as "C". The internal control line needs to be present on each respective test strip to indicate that the test works adequately in each lay user performed test. The control line contains IgG antibodies that capture the excess labeled mouse antibody preloaded in the conjugate pad. These controls must be positive for all valid test results to demonstrate that the test reagents are functional, and the tests correctly performed. If the control lines are not detected, the sample result is invalid.

#### ii. External Controls:

External Quality Control materials are not included in the test kit but are available separately for use by professional users.

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b. Stability

i. Real Time Stability:
Three lots of the QuickFinder COVID-19/Flu Antigen Test kits were subjected to temperatures expected for unopened kits when stored at the indicated storage condition, 2-30°C. The test kits were stored at 2°C/ambient humidity, 30°C/45% relative humidity (RH), and 30°C/95% relative humidity. The test panel comprised of un-spiked pooled nasal wash, 1X LoD and 4X LoD of inactivated SARS-CoV-2, and live Flu A and Flu B viruses, spiked into negative clinical matrix (PNW). Testing was performed at time 0 (baseline) and month 1, 2, 3, 4, 5, 6, 10, 12, 13, 18, and 19. All study data are 100% concordant with expected results and support a shelf-life of up to 18 months when stored between 2-30°C.

ii. Open Kit Stability Study:
In this study, the amount of time a test device can be left outside of its packaging was assessed using a test panel comprised of five (5) negative samples (clinical matrix: PNW) and five (5) co-spiked low positive samples (2X co-spike equivalency LoD of SARS-CoV-2, Flu A, and Flu B co-spiked together into PNW). PNW was demonstrated to be equivalent to negative nasal swab matrix in a matrix equivalency study. Device packaging was opened, and testing was performed at zero (0) hours to establish baseline. Thereafter, devices were stored for one-hour and two-hour, respectively at 30±1°C (the worst-case condition for a room temperature storage). All study data before and after storage of the open kits were 100% concordant with the expected results establishing stability of the open kit at room temperature as indicated in the instructions for use.

iii. Transport Stability:
Simulated winter and summer transport temperature conditions were used to evaluate the expected worst-case shipping and handling of unopened components of the QuickFinder COVID-19/Flu Antigen Test over an extended period. The functional performance of the QuickFinder COVID-19/Flu Antigen Test kits was assessed by comparing the pre- (T0) and post-distribution (Td) results of a test panel comprised of pooled negative nasal wash (PNW) samples and co-spiked low positive samples (3X co-spike equivalency LoD with SARS-CoV-2, Flu A, and Flu B, together contrived in PNW). PNW was demonstrated to be an equivalent negative clinical matrix to negative nasal swab matrix in a matrix equivalency study. All results were as expected for all time points.

6. Detection Limit:

a. Single Analyte LoD:
The LoD of the device was performed to determine the lowest detectable concentration of SARS-CoV-2, influenza A and influenza B at which at least 95% of all true positive replicates are consistently detected as positive. The LoD was assessed for each analyte in two parts, a preliminary range finding study, followed by a confirmatory LoD study.

The preliminary LoD was determined by first testing serial ten-fold dilutions of live influenza A and B, and inactivated SARS-CoV-2 virus stocks diluted into either pooled negative swab matrix (PNSM) in 3 replicates per dilution and lot. Once the ten-fold LoD range was established, additional two-fold dilutions of the lowest positive ten-fold dilution

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were tested in triplicate to determine the preliminary LoD of each virus. Single analyte virus dilutions (50 μL/swab) were each spiked onto dry sterile swabs and tested per the IFU. Total of three test kit lots have been tested to demonstrate LOD consistency across different device lots.

The preliminary LoD results for each individual virus strain are shown in the tables below.

Table 6: Preliminary LoD - SARS-CoV-2

|  Isolate/Lineage | SARS-CoV-2 (TCID_{50}/mL) | SARS-CoV-2 (TCID_{50}/Swab) | #Positive/# Total (All lots combined)  |
| --- | --- | --- | --- |
|  USA-WA1-2020 (UV inactivated) | 3.16E+05 | 1.58E+04 | 9/9  |
|   |  3.16E+04 | 1.58E+03 | 9/9  |
|   |  3.16E+03 | 1.58E+02 | 9/9  |
|   |  1.58E+03 | 7.90E+01 | 9/9  |
|   |  7.90E+02 | 3.95E+01 | 0/9  |
|   |  3.95E+02 | 1.98E+01 | 0/9  |
|   |  3.16E+02 | 1.58E+01 | 0/9  |

Table 7: Preliminary LoD - Influenza A

|  Isolate/Lineage | Strain | SARS-CoV-2 (TCID_{50}/mL) | SARS-CoV-2 (TCID_{50}/Swab) | #Positive/# Total (All lots combined)  |
| --- | --- | --- | --- | --- |
|  H3N2 | A/Darwin/6/2021 (live) | 4.17E+04 | 2.09E+03 | 9/9  |
|   |   |  4.17E+03 | 2.09E+02 | 9/9  |
|   |   |  4.17E+02 | 2.09E+01 | 9/9  |
|   |   |  2.09E+02 | 1.04E+01 | 9/9  |
|   |   |  1.04E+02 | 5.20E+00 | 0/9  |
|   |   |  5.21E+01 | 2.61E+00 | 0/9  |
|   |   |  4.17E+01 | 2.09E+00 | 0/9  |
|   |   |  4.17E+04 | 2.09E+03 | 0/9  |
|  H1N1 | A/Victoria/4897/2022 (live) | 2.02E+04 | 1.01E+03 | 9/9  |
|   |   |  2.02E+03 | 1.01E+02 | 9/9  |
|   |   |  2.02E+02 | 1.01E+01 | 9/9  |
|   |   |  1.01E+02 | 5.05E+00 | 0/9  |
|   |   |  5.05E+01 | 2.53E+00 | 0/9  |
|   |   |  2.53E+01 | 1.27E+00 | 0/9  |
|   |   |  2.02E+01 | 1.01E+00 | 0/9  |

Table 8: Preliminary LoD - Influenza B

|  Isolate/Lineage | Strain | SARS-CoV-2 (TCID_{50}/mL) | SARS-CoV-2 (TCID_{50}/Swab) | #Positive/# Total (All lots combined)  |
| --- | --- | --- | --- | --- |
|  Yamagata | B/Florida/4/2006 (live) | 1.17E+04 | 5.85E+02 | 9/9  |
|   |   |  1.17E+03 | 5.85E+01 | 9/9  |
|   |   |  1.17E+02 | 5.85E+00 | 9/9  |
|   |   |  5.85E+01 | 2.93E+00 | 9/9  |
|   |   |  2.93E+01 | 1.46E+00 | 9/9  |
|   |   |  1.46E+01 | 7.30E-01 | 0/9  |
|   |   |  1.17E+01 | 5.85E-01 | 0/9  |

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|  Isolate/Lineage | Strain | SARS-CoV-2 (TCID50/mL) | SARS-CoV-2 (TCID50/Swab) | #Positive/# Total (All lots combined)  |
| --- | --- | --- | --- | --- |
|  Victoria | B/Washington /02/2019 (live) | 3.16E+05 | 1.58E+04 | 9/9  |
|   |   |  3.16E+04 | 1.58E+03 | 9/9  |
|   |   |  3.16E+03 | 1.58E+02 | 9/9  |
|   |   |  1.58E+03 | 7.90E+01 | 0/9  |
|   |   |  7.90E+02 | 3.95E+01 | 0/9  |
|   |   |  3.95E+02 | 1.98E+01 | 0/9  |
|   |   |  3.16E+02 | 1.58E+01 | 0/9  |

LoD confirmatory testing was then performed individually for each of the viral strains by testing 20 replicates at the virus' preliminary (1X) LoD concentration, as determined above. For the LoD to be confirmed, at least  $95\%$  of the replicates  $(\geq 19 / 20)$  needed to test positive. Results of the LoD confirmation testing for each virus are summarized in the table below.

Table 9: Confirmatory LoD

|  Analyte | Isolate/ Lineage | Strain | LoD Concentration (TCID50/mL) | LoD per Swab (TCID50/swab) | #Positive/ # Total (All lots combined)  |
| --- | --- | --- | --- | --- | --- |
|  SARS-CoV-2 | USA-WA1/2020 (UV inactivated) | NA | 1.58E+03 | 7.90E+01 | 60/60  |
|  Flu A | H3N2 | Darwin/6/21 | 2.09E+02 | 1.04E+01 | 60/60  |
|   |  H1N1 | Victoria/4897/22 | 2.02E+02 | 1.01E+01 | 60/60  |
|  Flu B | Yamagata | Florida/04/06 | 2.93E+01 | 1.46E+00 | 60/60  |
|   |  Victoria | Washington/02/19 | 3.16E+03 | 1.58E+02 | 60/60  |

# b. Co-spiked LoD:

After the single-analyte LoDs were established for the candidate device, co-spiked LoD equivalency testing with all three test analytes present in the same sample, was conducted to characterize performance with samples that contain more than one analyte at low concentrations.

Based on the individual analyte specific 1X LoD concentrations, co-spiked samples were prepared by mixing all three viruses (one strain each of SARS-CoV-2, Flu A and Flu B). The 1X co-spiked LoD concentration was tested with the candidate device in twenty (20) replicates with one lot and was considered confirmed (i.e., equivalent to the established single analyte LoD) if  $\geq 19/20$  replicates were positive for concentrations within 2X LoD of the established single analyte LoD.

The QuickFinder COVID-19/Flu Antigen Test demonstrated co-spiked LoD equivalency for all analytes, SARS-CoV-2, Flu A and Flu B, to their respective established single analyte 1X LoD concentration. Since all analytes are successfully detected by the candidate device when co-spiked at their single-analyte LoD, co-spiking of the analytes into the same positive sample/s is supported for use in the analytical studies. The summary of the co-spiked LoD is shown in the below table.

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Table 10: Summary of Co-Spike LoD Equivalency Results

|  Virus | Fold single-analyte LoD | LoD Concentration (TCID_{50}/mL) | LoD per Swab (TCID_{50}/swab) | # Positive Replicates  |
| --- | --- | --- | --- | --- |
|  SARS-CoV-2 (USA-WA1/2020) | 1X | 1.58 x 10^{3} | 7.90 x 10^{1} | 20/20  |
|  Flu B Yamagata (B/Florida/4/2006) | 1X | 2.93 x 10^{1} | 1.47 x 10^{0} | 20/20  |
|  Flu A H1N1 (pdm09:A/Victoria/4897/2022) | 1X | 2.09 x 10^{2} | 1.05 x 10^{1} | 20/20  |

c. Detection Limit with the NIBSC 21/368 - WHO International Standard:

The sponsor tested the sensitivity of the test with the 1st WHO International Standard for SARS-CoV-2 antigen (NIBSC code: 21/368) spiked into pooled negative swab matrix (PNSM). A 2-fold dilution series was made to determine the preliminary LoD, which was measured using one device lot and triplicate measurements (n=3). The measurements were done by adding 50μl of each dilution directly to the test swab and processing the sample per the test's QRI. The preliminary LoD was determined to be 1000 IU/ml (or 50 IU/swab).

The LoD confirmatory study was performed using 20 replicates (n=20) per dilution. The lowest concentration at which a minimum of 95% of results were positive was confirmed to be 1000 IU/ml or 50 IU/swab as shown below.

Table 11: LOD with the 1<sup>st</sup> WHO International Standard for SARS-CoV-2 Antigen (NIBSC code: 21/368)

|  Preliminary LoD  |   |   |
| --- | --- | --- |
|  Concentration (IU/ml) | IU/swab | Results  |
|  4x10^{3} | 200 | 3/3  |
|  2x10^{3} | 100 | 3/3  |
|  1x10^{3} | 50 | 3/3  |
|  4x10^{2} | 20 | 0/3  |
|  2x10^{2} | 10 | 0/3  |
|  Confirmatory LoD  |   |   |
| --- | --- | --- |
|  Concentration (IU/ml) | IU/swab | Results  |
|  |   |   |
|  2x10^{3} | 100 | 20/20  |
|  1x10^{3} | 50 | 20/20  |
|  5x10^{2} | 25 | 0/20  |
|  |   |   |

7. High-Dose Hook Effect Study:

The hook effect study was conducted to evaluate if high levels of antigen present in the sample could result in a false negative test result. In this study, 50μL of the highest concentration possible for UV inactivated SARS-CoV-2 virus stock and for live influenza A and influenza B virus stocks were spiked onto sterile swabs for triplicate measurements, and swabs were tested on the device per IFU of the candidate device.

Testing showed no hook effect for SARS-CoV-2, Flu A, Flu B at the concentrations listed in the table below.

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Table 12: Summary of High Dose Hook Effect Results

|  Virus | Strain | Subtype or Lineage | Virus Concentration [TCID50/mL] | Virus Concentration [TCID50/swab] | # Positive/# Total  |
| --- | --- | --- | --- | --- | --- |
|  SARS-CoV-2 | USA-WA1/2020 | N/A | 3.16E+06 | 1.58E+05 | 3/3  |
|  Influenza A | A/Victoria/4897/2022 | H1N1pdm09 | 2.02E+05 | 1.01E+04 | 3/3  |
|  Influenza A | A/Darwin/6/21 | H3N2 | 4.17E+05 | 2.09E+04 | 3/3  |
|  Influenza B | B/Washington/02/2019 | Victoria | 3.16E+06 | 1.58E+05 | 3/3  |
|  Influenza B | B/Florida/4/2006 | Yamagata | 1.17E+05 | 5.85+03 | 3/3  |

# 8. Inclusivity Study:

Analytical reactivity testing was performed for the QuickFinder COVID-19/Flu Antigen Test to determine if the device can detect the target analytes across a variety of strains. A selection of temporally, geographically, and genetically diverse SARS-CoV-2 and influenza strains were tested for inclusivity. An LoD study was conducted on a total of 23 Influenza A strains (11 H1N1, 1 H1N2, and 6 H3N2, 2 H5N1, 1 H5N6, 1 H5N8, 1 H7N3), and 10 Influenza B strains (1 non-Victoria and non-Yamagata, 4 Yamagata and 5 Victoria lineages). A series of three (3) ten-fold dilutions of each virus was spiked into PNSM and tested. Once the ten-fold LoD range was established for each strain, an additional series of 3 two-fold dilutions of the lowest positive ten-fold dilution for each virus was tested in triplicate to demonstrate inclusivity. Contemporary strains (within the past 5 years) were prioritized over older strains. Results are summarized below.

Table 13: Minimal Detectable Concentrations of SARS-CoV-2, Influenza A, and Influenza B Variants

|  Target Analyte | Strain | Concentration  |   |
| --- | --- | --- | --- |
|  SARS-CoV-2 | USA-WA1/2020 (UV inactivated) | 1.58 x 103 | TCID50/mL  |
|   |  Xbb 1.5 Omicron Variant (heat inactivated) | 4 × 102 | TCID50/mL  |
|  Influenza A (H1N1pdm09) | A/California/04/2009 | 2.80 × 103 | TCID50/mL  |
|   |  A/Brisbane/02/2018 | 1.89 × 102 | TCID50/mL  |
|   |  A/Michigan/45/2015 | 1.86 × 101 | TCID50/mL  |
|   |  A/Guangdong-Maonan/SWL 1536/2019 | 1.04 × 103 | TCID50/mL  |
|   |  A/NY/03/2009 | 4.57 × 104 | TCID50/mL  |
|   |  A/Indiana/02/2020 | 9.70 × 106 | CEID50/mL  |
|   |  A/Wisconsin/588/2019 | 2.80 × 104 | FFU/mL  |
|   |  A/Sydney/5/2021 | 6.00 × 103 | TCID50/mL  |
|   |  A/Hawaii/66/2019 | 7.40 × 107 | CEID50/mL  |
|   |  A/Wisconsin/67/2022 | 4.21 × 102 | TCID50/mL  |
|  Influenza A (H1N1)v | A/Ohio/09/2015 | 1.40 × 106 | CEID50/mL  |
|  Influenza A (H1N2)v | A/Minnesota/19/2011 | 8.0 × 106 | CEID50/mL  |
|  Influenza A (H3N2) | A/New York/21/2020 | 3.25 × 105 | FFU/mL  |
|   |  A/Tasmania/503/2020 | 1.30 × 105 | FFU/mL  |
|   |  A/Alaska/01/2021 | 3.75 × 104 | FFU/mL  |
|   |  A/Hong Kong/45/2019 | 3.75 × 104 | FFU/mL  |
|   |  A/Hong Kong/2671/2019 | 1.05 × 103 | TCID50/mL  |
|   |  A/Indiana/08/2011 | 8.10 × 102 | TCID50/mL  |
|  Influenza A (H5N1) | A/mallard/Wisconsin/2576/2009 | 4.0 × 106 | CEID50/mL  |

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|  Target Analyte | Strain | Concentration  |   |
| --- | --- | --- | --- |
|   | A/bovine/Ohio/B24OSU-439/2024 | 7.8 x 103 | TCID50/mL  |
|   |  A/duck/Guangxi/S11002/ 2024 | 1.69x 106 | EID50/mL  |
|  Influenza A (H5N6) | A/duck/Guangxi/S10888/2024 | 1.69x 106 | EID50/mL  |
|  Influenza A (H5N8) | A/goose/Liaoning/S1266/2021 | 1.69x 106 | EID50/mL  |
|  Influenza A (H7N3) | A/northern pintail/Illinois/ 10O53959/2010 | 2.8 × 106 | CEID50/mL  |
|  Influenza B (Victoria) | B/Brisbane/60/2008 | 1.61 × 100 | TCID50/mL  |
|   |  B/Colorado/06/2017 | 2.93 × 101 | TCID50/mL  |
|   |  B/Texas/02/2013 | 2.45 × 101 | TCID50/mL  |
|   |  B/Washington/02/2019 | 3.16 x 103 | TCID50/mL  |
|   |  B/Michigan/01/2021 | 1.43 × 104 | TCID50/mL  |
|  Influenza B (Yamagata) | B/Texas/06/2011 | 1.51 × 103 | TCID50/mL  |
|   |  B/Utah/09/2014 | 1.26 × 103 | TCID50/mL  |
|   |  B/Florida/04/2006 | 2.93 x 101 | TCID50/mL  |
|   |  B/Wisconsin/01/2010 | 1.78 × 102 | TCID50/mL  |
|  Influenza B (non-Victoria, non-Yamagata) | B/Maryland/1/1959 | 3.38 × 103 | CEID50/mL  |

# 9. Assay Cut-Off:

Not applicable as this is a qualitative visually read assay without numeric raw data.

# B Comparison Studies:

# 1. Method Comparison with Predicate Device:

Please refer to section VI.C (Clinical Studies) below for the clinical validation, regarding the method comparison studies.

# 2. Matrix Equivalency:

The candidate device is only intended for qualitative detection of nucleocapsid protein antigen from SARS-CoV-2, and nucleoprotein from Flu A and Flu B in direct anterior nasal swab specimens. As no other sample types are claimed herein, a matrix comparison study is not applicable.

However, the sponsor performed the matrix equivalency study between pooled negative nasal swab matrix (PNSM) and the surrogate pooled negative nasal wash (PNW) that was used in multiple analytical studies. The data demonstrated equivalent performance of the test with both matrices.

# C Clinical Studies:

# 1. Clinical Performance Assessment:

A multi-center, prospective clinical study was conducted with lay users to assess the performance of the QuickFinder COVID-19/Flu Antigen Self Test in detecting nucleoprotein antigens extracted from COVID-19, influenza virus A, and influenza virus B in self-collected and self-tested anterior nasal swab samples. The study only enrolled lay user subjects with two or more symptoms of respiratory infection consistent with COVID-19 or influenza. Six clinical sites (one

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site with two locations) across the U.S. conducted the study from October 9, 2023, to June 13, 2024.

Both the comparator and the candidate test used anterior nasal swab samples and the collection order was alternated by study subject. Comparator test samples were collected by health care professionals at the clinical study sites and inserted into Universal Transport Media per the IFU of the comparator test. Samples were then sent to a reference laboratory for testing with highly sensitive RT-PCR tests separately detecting SARS-CoV-2 and Flu A/B. Samples for the candidate antigen test were collected per the test's quick reference instructions and were either self-collected by a lay user aged  $\geq 14$  years or collected by an adult (parent/guardian) from individuals aged 2 to  $&lt; 14$  years.

There were 794 symptomatic subjects enrolled with symptom onset between 0 and 4 days who conducted testing using the QuickFinder COVID-19/Flu Antigen Self Test summary instructions (QRI). Of those, 788 subjects were evaluable for SARS-CoV-2, Flu A, and B. The study cohort included  $21\%$  low positive samples. The age of participants ranged from 2 years old to 80 years old, with a mean of 34.6 years. The education level of subjects ranged from less than high school diploma to doctorate degree. The demographics of the subjects involved in the clinical study are shown in the table below.

Table 14. Subject Demographics

|   | Subjects with collection and testing by lay-caregiver (N=111) | Self-collecting and testing (N=677) | Overall (N=788)  |
| --- | --- | --- | --- |
|  Age  |   |   |   |
|  Mean (SD) | 11.1 (12.1) | 38.4 (16.3) | 34.6 (18.4)  |
|  Median [Min, Max] | 9 [2, 74] | 36 [14, 80] | 32 [2, 80]  |
|  Age Group  |   |   |   |
|  ≥2-<14 years of age | 104 (93.7%) | 0 (0.0%) | 104 (13.2%)  |
|  14-24 years of age | 2 (1.8%) | 176 (26.0%) | 178 (22.6%)  |
|  >24-64 years of age | 1 (0.9%) | 445 (65.7%) | 446 (56.6%)  |
|  ≥65 years of age | 4 (3.6%) | 56 (8.3%) | 60 (7.6%)  |
|  Sex at Birth  |   |   |   |
|  Female | 48 (43.2%) | 414 (61.2%) | 462 (58.6%)  |
|  Male | 63 (56.8%) | 263 (38.8%) | 326 (41.4%)  |
|  Ethnicity  |   |   |   |
|  Hispanic/Latino | 5 (4.5%) | 109 (16.1%) | 114 (14.5%)  |
|  Not Hispanic/Latino | 106 (95.5%) | 568 (83.9%) | 674 (85.5%)  |
|  Race  |   |   |   |
|  American Indian or Alaskan Native | 0 (0.0%) | 0 (0.0%) | 0 (0.0%)  |
|  Asian | 0 (0.0%) | 11 (1.6%) | 11 (1.4%)  |
|  Black or African American | 4 (3.6%) | 54 (8.0%) | 58 (7.4%)  |
|  Native Hawaiian/Pacific Islander | 0 (0.0%) | 5 (0.7%) | 5 (0.6%)  |
|  White | 100 (90.1%) | 596 (88.0%) | 696 (88.3%)  |
|  Unknown/Prefer not to answer | 0 (0.0%) | 2 (0.3%) | 2 (0.3%)  |
|  Other (Mixed race/biracial) | 7 (6.3%) | 9 (1.3%) | 16 (2.0%)  |
|  Education Level (testers and subjects self-collecting and testing)  |   |   |   |
|  Less than high school diploma | 8 (7.2%) | 84 (12.4%) | 92 (11.6%)  |
|  High school diploma | 1 (0.9%) | 10 (1.5%) | 11 (1.4%)  |
|  Some college | 1 (0.9%) | 10 (1.5%) | 11 (1.4%)  |
|  Graduate | 0 (0.0%) | 0 (0.0%) | 0 (0.0%)  |
|  Not Applicable | 0 (0.0%) | 0 (0.0%) | 0 (0.0%)  |

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|   | Subjects with collection and testing by lay-caregiver (N=111) | Self-collecting and testing (N=677) | Overall (N=788)  |
| --- | --- | --- | --- |
|  High school diploma | 63 (56.8%) | 196 (29.0%) | 259 (32.9%)  |
|  Some college, but no degree | 24 (21.6%) | 115 (17.0%) | 139 (17.6%)  |
|  Associate degree (e.g., AA, AS) | 3 (2.7%) | 31 (4.6%) | 34 (4.3%)  |
|  Bachelor’s Degree (e.g., BA, BBA and BS) | 7 (6.3%) | 164 (24.2%) | 171 (21.7%)  |
|  Master’s Degree (e.g., MA, MS and Meng) | 0 (0.0%) | 49 (7.2%) | 49 (6.2%)  |
|  Professional Degree (e.g., MD, DDS, JD) | 0 (0.0%) | 2 (0.3%) | 2 (0.3%)  |
|  Doctorate (e.g., PhD, EdD) | 0 (0.0%) | 1 (0.1%) | 1 (0.1%)  |
|  Other | 6 (5.4%) | 35 (5.2%) | 41 (5.2%)  |
|  Household Income (testers and subjects self-collecting and testing)  |   |   |   |
|  less than $15,000 | 17 (15.3%) | 143 (21.1%) | 160 (20.3%)  |
|  $15,001 to $45,000 | 56 (50.5%) | 178 (26.3%) | 234 (29.7%)  |
|  $45,001 to $90,000 | 29 (26.1%) | 164 (24.2%) | 193 (24.5%)  |
|  $90,001 to $150,000 | 5 (4.5%) | 107 (15.8%) | 112 (14.2%)  |
|  $150,001 to $300,000 | 3 (2.7%) | 47 (6.9%) | 50 (6.3%)  |
|  over $300,000 | 0 (0.0%) | 0 (0.0%) | 0 (0%)  |
|  Other | 1 (0.9%) | 38 (5.6%) | 39 (4.9%)  |

Results obtained with the QuickFinder COVID-19/Flu Antigen Self Test were compared to the results obtained with highly sensitive RT-PCR comparator tests giving rise to the following performance estimates:

Table 15: Clinical Performance for Detection of SARS-CoV-2

|  SARS-CoV-2 | Comparator Positives | Comparator Negatives | Total  |
| --- | --- | --- | --- |
|  Candidate Positives | 116 | 4 | 120  |
|  Candidate Negatives | 12 | 656 | 668  |
|  Total | 128 | 660 | 788  |

Positive Percent Agreement  $= (116 / 128) = 90.6\%$  (95% CI: 84.3% - 94.6%)
Negative Percent Agreement  $= (656 / 660) = 99.4\%$  (95% CI: 98.5% - 99.8%)

Results for SARS-CoV-2 were also analyzed stratified by the number of days post symptom onset (DPSO) and are presented in Table 16 below.

Table 16: Clinical Performance for Detection of SARS-CoV-2 stratified by DPSO

|  DPSO* | Number of Subject samples tested | Investigational Positives | Comparator Positives | % Positive Rate (by Comparator) | PPA (95% CI)  |
| --- | --- | --- | --- | --- | --- |
|  0 | 19 | 0 | 0 | 0.0% | NA  |
|  1 | 180 | 27 | 31 | 17.2% | 87.1% (71.1% - 94.9%)  |
|  2 | 274 | 39 | 45 | 16.4% | 86.7% (73.8% - 93.7%)  |
|  3 | 185 | 32 | 33 | 17.8% | 97.0% (84.7% -99.8%)  |

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|  DPSO* | Number of Subject samples tested | Investigational Positives | Comparator Positives | % Positive Rate (by Comparator) | PPA (95% CI)  |
| --- | --- | --- | --- | --- | --- |
|  4 | 130 | 18 | 19 | 14.6% | 94.7% (75.4% - 99.7%)  |
|  Total | 788 | 116** | 128 | 16.2% | 90.6% (84.3% - 94.6%)  |

* DPSO: Days Post Symptom Onset
**False positive results on the investigational device were excluded from the analysis.

Table 17: Clinical Performance for Detection of Influenza A

|  FLU A | Comparators Positives | Comparators Negatives | Total  |
| --- | --- | --- | --- |
|  Candidate Positives | 52 | 9 | 61  |
|  Candidate Negatives | 6 | 721 | 727  |
|  Total | 58 | 730 | 788  |

Positive Percent Agreement = (52/58) = 89.7% (95% CI: 79.2% - 95.2%)
Negative Percent Agreement = (721/730) = 98.8% (95% CI: 97.7% - 99.4%)

Table 18: Clinical Performance for Detection of Influenza B

|  FLU B | Comparators Positives | Comparators Negatives | Total  |
| --- | --- | --- | --- |
|  Candidate Positives | 37 | 2 | 39  |
|  Candidate Negatives | 6 | 743 | 749  |
|  Total | 43 | 745 | 788  |

Positive Percent Agreement = (37/43) = 86% (95% CI: 72.7% - 93.4%)
Negative Percent Agreement = (743/745) = 99.7% (95% CI: 99% - 99.9%)

## Clinical Sensitivity:

Please refer to Section VI.C (Clinical Studies) above for the clinical validation. The PPA for the test for each analyte is as follows:

- SARS-CoV-2: 90.6% (116/128) - 95% CI: 84.3% - 94.6%
- Flu A: 89.7% (52/58) - 95% CI: 79.2% - 95.2%
- Flu B: 86% (37/43) - 95% CI: 72.7% - 93.4%

## Clinical Specificity:

Please refer to Section VI.C (Clinical Studies) above for the clinical validation. The NPA for the test for each analyte is as follows:

- SARS-CoV-2: 99.4% (95% CI: 98.5% - 99.8%)
- Flu A: 98.8% (95% CI: 97.7% - 99.4%)
- Flu B: 99.7% (95% CI: 99.0% - 99.9%)

## 2. Usability Study:

Usability study was conducted to evaluate the usability of the QuickFinder COVID-19/Flu Antigen Self Test and to evaluate the labeling and comprehension of the subject test QRI when performed by lay users in a simulated home environment. The study was conducted as part of the clinical study from October 11 – November 3, 2023. The first fifteen (15) or more subjects from the clinical study who were self-collecting and testing, and the first fifteen (15) or more subjects collecting a sample and performing the testing on another subject (child or adult), were selected

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to participate in the human factors assessment. The demographics of the usability study is tabulated below.

Table 19: Demographics of the Usability Study Population

|  Factor | Lay-user (Tester) collection and testing (N=25) | Self-collecting and testing (N=25) | Overall (N=50)  |
| --- | --- | --- | --- |
|  Subject Age  |   |   |   |
|  Mean (SD) | 19.5 (23.1) | 35.2 (14.9) | 27.4 (20.8)  |
|  Median [Min,Max] | 10 [2, 74] | 33 [19, 65] | 21 [2, 74]  |
|  Subject Age Group  |   |   |   |
|  2-<14 years of age | 20 (80.0%) | 0 (0.0%) | 20 (40.0%)  |
|  14-24 years of age | 0 (0.0%) | 9 (36%) | 9 (18%)  |
|  >24-64 years of age | 1 (4%) | 15 (60%) | 16 (32%)  |
|  ≥65 years of age | 4 (16%) | 1 (4%) | 5 (10%)  |

The human factors assessment portion of the study was completed per the protocol. Fifty (50) subjects (25 self-collecting and testing, and 25 lay users collecting and testing from another) were enrolled in the human factors assessment. Evaluation of the human user experience indicated high usability of the investigational test. All subjects who participated found the instructions to be clear and easy to follow and found the sample collection easy to perform, as well as having no difficulty reading the test results. Overall,  $93\%$  of all critical tasks associated with sample collection and the running of the QuickFinder COVID-19/Flu Antigen Self Test Cassette (Swab) were performed correctly. Additionally,  $88\%$  of all non-critical tasks were performed correctly. The human factors assessment met the predetermined targets for the percentage of critical and noncritical tasks performed correctly as shown in the table below.

Table 20: Usability Study Results

|  Steps | Tasks performed correctly | Total number of tasks | Percentage of tasks performed correctly  |
| --- | --- | --- | --- |
|  Critical | 370 | 400 | 93%  |
|  Non-Critical | 176 | 200 | 88%  |
|  Total | 546 | 600 | 91%  |

# 3. Lay User Readability Study:

All 50 subjects who participated in the human factors assessment (Usability study) also interpreted a panel of mock investigational tests with various results that reflected the test concentration levels at  $1.9\mathrm{X}$  and  $5\mathrm{X}$  the limits of detection (LoD) in a blinded and random fashion. Each panel of mock tests included 16 investigational tests with various negative and positive results for each analyte. Vision impairments encountered in study subjects are listed in the table below with their respective frequency of occurrence. The study did not include individuals with any of the following: macular degeneration, color blindness, diabetic retinopathy, cataracts, or amblyopia/strabismus. The percentage of total human factor subjects with vision impairment is  $14\%$  (7/50). The overall accuracy of the results interpreted by the lay users in the clinical study, with and without vision impairment, is  $93.6\%$  (747/798),  $95\%$  CI:  $91.7\% - 95.1\%$ .

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Table 21: Vision Impairment of Readability Study Subjects

|  Type of vision impairment | # of testers | Percentage of total number of vision impaired testers (N=50)  |
| --- | --- | --- |
|  Near sightedness only (with lens prescription) | 1 | 2.0%  |
|  Far sightedness only (with lens prescription) | 3 | 6.0%  |
|  Astigmatism | 2 | 4.0%  |
|  Glaucoma | 1 | 2.0%  |
|  More than one visual impairment condition | 0 | 0.0%  |
|  Total testers with vision impairment | 7 | 14%  |

The comparison of result interpretation data between lay users with and without visual impairment is tabulated below.

Table 22: Lay User Readability Study Results

|  Mock Results Type | LoD Equivalent of Line intensity | Percent Accuracy of Mock Test Interpretations  |   |
| --- | --- | --- | --- |
|   |   |  Subjects Without Visual Impairment (N=43) | Subjects with Visual Impairment (N=7)  |
|  Flu A+ & Flu B+ | 1.9 X LoD | 100.0% | 85.7%  |
|  COV-19+ /Flu A+ | 1.9 X LoD | 81.4% | 100.0%  |
|  COV-19+ /Flu A+ & Flu B+ | 1.9 X LoD | 100.0% | 100.0%  |
|  COV-19+ /Flu B+ | 1.9 X LoD | 81.4% | 100.0%  |
|  COV+ | 1.9 X LoD | 100.0% | 100.0%  |
|  Flu A+ | 1.9 X LoD | 93.0% | 100.0%  |
|  Flu B+ | 1.9 X LoD | 93.0% | 100.0%*  |
|  Flu A+ & Flu B+ | 5 X LoD | 97.7% | 100.0%  |
|  COV-19+ /Flu A+ | 5 X LoD | 86.1% | 100.0%  |
|  COV-19+ /Flu A+ & Flu B+ | 5 X LoD | 100.0% | 100.0%*  |
|  COV-19+ /Flu B+ | 5 X LoD | 88.4% | 85.7%  |
|  COV+ | 5 X LoD | 95.3% | 100.0%  |
|  Flu A+ | 5 X LoD | 93.0% | 100.0%  |
|  Flu B+ | 5 X LoD | 93.0% | 85.7%  |
|  Invalid (absent control line) | - | 93.0% | 100.0%  |
|  Negative (no analyte but control line present) | - | 93.0% | 100.0%  |
|  Total |  | 93.0% | 95.5%  |

*Results from one (1) subject was removed from the analysis due to protocol deviation (N=6).

# D Clinical Cut-Off:

Not Applicable. The candidate device is a qualitative assay with a visually read binary result without numeric raw data.

# E Expected Values/Reference Range:

A patient sample is expected to be negative for SARS-CoV-2, influenza A and influenza B. This section is therefore not applicable.

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F Other Supportive Information:

1. Variant Monitoring Plan:

To determine whether the QuickFinder COVID-19/Flu Antigen Test can detect newly emerging variants, and/or to assess whether new mutations are impacting analytical sensitivity of the test performance, the sponsor provided the variant monitoring plan as described below:

a. Monitoring SARS-CoV-2, Influenza A and B sequence data in GISAID database, WHO, NIH and other public health entities: The updated sequence data for SARS-CoV-2, influenza A and influenza B variants from GISAID database, WHO, NIH and other public health entities will be downloaded and analyzed bimonthly for variant mutations in the target proteins with an allele frequency of ≥5%.

b. In silico analysis of antigenicity of the N proteins: In silico monitoring of antigen variations caused by changes in amino acid residues will be performed by analyzing epitopes through sequence alignments.

c. If based on the in-silico analysis of a. and b. above the test recognized epitope/s is/are affected by new mutation/s, evaluation using virus culture fluid will be performed.

d. If available, evaluation of new strains using clinical SARS-CoV-2, Influenza A, and Influenza B positive samples will be conducted.

2. Frequently Asked Questions:

To improve user label comprehension, the labeling includes a Frequently Asked Questions (FAQ) section. The FAQ section was created to provide users information to adequately understand the meaning of the test results and test types as well as the accuracy of the test. The concepts covered in the FAQ section include:

- Meaning of the test results
- When to re-test (e.g., following an invalid result)
- Difference between antigen and molecular test
- Accuracy of the test
- Follow-up for appropriate health management.

3. Hazard Analysis:

A comprehensive hazard analysis of the QuickFinder COVID-19/Flu Antigen Test included identification of the potential hazard, likelihood of occurrence, severity of potential harm, hazard control measure(s), hazard control verification, and assignment of pre- and post-control risk levels. The elements considered included operator errors (i.e., human factors), sample and device handling and storage, and environmental factors.

Potential sources of errors that could adversely affect system performance were identified and mitigated through cautions in the labeling. The identified risks which could result in erroneous test results were evaluated in flex studies that evaluated the functionality of fail-safe mechanisms and stressed the functional limits of the test system (see below).

4. Fail Safe Features:

The device features an internal control to minimize false results due to user error. The internal control monitors for grossly insufficient sample volume, adequate membrane wicking, and sample flow.

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5. **Flex Studies:**

To assess the robustness and risk for false results of the test when deviating from the IFU/QRI test steps, flex studies were conducted that assessed all major aspects of the test procedure [e.g., sample volume, reading time, swab extraction time and procedure (delay in mixing and addition of the sample), sample hold time before and during processing] and variability of environmental test conditions that the test may be subjected to when in use (e.g., lighting, disturbance during use, temperature and humidity stress conditions). Testing was performed with negative PNW samples and low positive samples co-spiked with SARS-CoV-2, Flu A, and Flu B virus into negative PNW at 2X LoD.

The results demonstrated that the test system is robust and that false results can be expected to be reasonably mitigated through labeling.

**VII. Proposed Labeling:**

The labeling supports the finding of substantial equivalence for this device.

**VIII. Conclusion:**

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K243262](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K243262)

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