QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test

K243262 · Osang, LLC · SCA · Jan 13, 2025 · Microbiology

Device Facts

• Record ID: K243262
• Device Name: QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test
• Applicant: Osang, LLC
• Product Code: SCA · Microbiology
• Decision Date: Jan 13, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3987
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Indications for Use

Indicated for symptomatic individuals aged 2 years and older (self-test or adult-assisted) for qualitative detection and differentiation of SARS-CoV-2 nucleocapsid, influenza A nucleoprotein, and influenza B nucleoprotein antigens in anterior nasal swab samples. Negative results are presumptive; follow-up with molecular assay recommended if symptoms persist.

Regulatory Classification

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)

Submission Summary (Full Text)

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

January 13, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Osang LLC % Lisa Baumhardt Senior Medical Device Regulatory Expert Hyman, Phelps and McNamara, P.C. 700 Thirteenth Street, N.W. Suite 1200 Washington, District of Columbia 20005-5929

Re: K243262

| Trade/Device Name: | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu<br>Antigen Pro Test |
|--------------------|-------------------------------------------------------------------------------------------|
| Regulation Number: | 21 CFR 866.3987 |
| Regulation Name: | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Regulatory Class: | Class II |
| Product Code: | SCA |
| Dated: | October 14, 2024 |
| Received: | October 15, 2024 |

Dear Lisa Baumhardt:

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 (the 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 available 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.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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-regulatory

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

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Silke Digitally signed by Silke Schlottmann -S Schlottmann -S Date: 2025.01.13 19:58:26 -05'00'

Silke Schlottmann Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K243262

#### Device Name

QuickFinder COVID-19/Flu Antigen Self Test QuickFinder COVID-19/Flu Antigen Pro Test

#### Indications for Use (Describe)

QuickFinder COVID-19/Flu Antigen Self Test

The QuickFinder™ COVID-19Flu Antigen Self Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of 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 nonprescription 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 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 subsition 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 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 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 subsition for a visit to a healthcare provider or appropriate follow-up.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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

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

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

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

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

Image /page/5/Picture/0 description: The image shows the logo for Osang Healthcare. The logo consists of the letters OHC in a bold, sans-serif font. Below the letters is the text "OSANG HEALTHCARE" in a smaller, sans-serif font. The logo is black and white.

## QuickFinder™ COVID-19/Flu Antigen Self Test

## QuickFinder™ COVID-19/Flu Antigen Pro Test

#### 510(k) Summary

In accordance with 21 CFR 807.87(h) and 21 CDR 807.92, the following 510(k) Summary for QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is provided:

| Submitter Information | |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant/Submitter: | OSANG Healthcare Co. Ltd.<br>132, Anyangcheondong-Ro<br>Dongan-Gu<br>Anyang Gyeonggi, Republic of Korea 14040<br>Phone: [phone] |
| Date Prepared: | January 10, 2025 |
| Contact Person: | Lisa Baumhardt, Sr. Medical Device Regulatory Consultant<br>Hyman, Phelps, & McNamara, P.C.<br>Phone: [phone]<br>Email: [e-mail] |
| Secondary Contact | Seungyeob Lee<br>OSANG LLC<br>625 Fair Oaks Ave. Ste 360<br>South Pasadena, CA 91030<br>Phone: [phone]<br>Email: [e-mail] |
| Identification of the Device | |
| Trade Name: | QuickFinder ^TM COVID-19/Flu Antigen Self Test<br>QuickFinder ^TM COVID-19/Flu Antigen Pro Test |
| Common Name: | Multi-analyte respiratory virus antigen detection test |
| Classification Name | Multi-analyte respiratory virus antigen detection test<br>21 C.F.R. 866.3987 |
| Product Code: | SCA |
| Device Class: | Class II |
| Predicate Device(s) | |
| Predicate Device(s): | Healgen Rapid Check COVID-19/Flu A & B Antigen Test<br>(DEN240029) |

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

Image /page/6/Picture/0 description: The image shows the logo for Osang Healthcare. The logo consists of the letters "OHC" in a bold, sans-serif font. Below the letters, the words "OSANG HEALTHCARE" are written in a smaller, sans-serif font. The logo is black and white.

## Intended Use/ 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 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 bv 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.

## 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 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 Description

The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is a rapid lateral flow test for the qualitative detection of the SARS-CoV-2, Influenza A and Influenza B using anterior nares nasal swab samples from those who are suspected of COVID-19, Influenza A, and Influenza B. The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is validated for testing direct samples without transport media.

The lateral flow test is for:

- . Self-collected anterior nasal (nares) swab specimens from individuals aged 14 years and older with symptoms of COVID-19 within the first 4 days of symptom onset.

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

Image /page/7/Picture/0 description: The image shows the logo for Osang Healthcare. The logo consists of the letters OHC in a bold, sans-serif font. Below the letters is the text "OSANG HEALTHCARE" in a smaller, sans-serif font. The logo is black and white.

- Adult-collected anterior nasal (nares) swab specimens from individuals aged 2 years ● and older with symptoms of COVID-19 within the first 4 days of symptom onset.
The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is a lateral flow test. The cassette contains membranes which are pre-coated with anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies and anti-influenza B nucleoprotein monoclonal antibodies on the test lines. Another anti-SARS-CoV-2 nucleocapsid protein monoclonal antibodies, anti-influenza A nucleoprotein monoclonal antibodies and anti-influenza B nucleoprotein monoclonal antibodies are each bound to the beads. When the sample is put into the sample well, the antibodies bound to the beads and the antigen in the sample bind to form complexes and migrate to the membrane. The complexes will be captured by coated antibodies on the membrane, and then the line will form a visible line. The presence of SARS-CoV-2, influenza A and influenza B antigens are indicated by lines visible in the Smarked position, A-marked position, and B-marked position in the results window, respectively. If no colored line appears on the control line (C), it implies that the test has not worked as intended.

## Substantial Equivalence

The proposed QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COV/ID-19/Flu Antigen Pro Test have similar indications for use to, and use the same fundamental technology as, the legally marketed predicate device to which substantial equivalence is claimed, the Healgen Rapid Check COVID-19/Flu A & B Antigen Test (DEN240029).

| Specification | Proposed Device:<br>QuickFinder™ COVID-19/Flu<br>Antigen Self Test / QuickFinder™<br>COVID-19/Flu Antigen Pro Test | Predicate Device:<br>Heaglen Rapid Check COVID-<br>19/Flu A & B Antigen Test<br>DEN240029 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Over-the-counter test to detect SARS-<br>CoV-2 and Influenza A and B from<br>clinical specimens. | Over-the-counter test to detect<br>SARS-CoV-2 and Influenza A and<br>B from clinical specimens. |
| Indications for<br>Use | QuickFinder™ COVID-19/Flu Antigen<br>Self Test<br>The QuickFinder™ COVID-19/Flu<br>Antigen Self Test is a lateral flow<br>immunochromatographic assay intended<br>for the qualitative detection and<br>differentiation of influenza A and<br>influenza B nucleoprotein antigens and<br>SARS-CoV-2 nucleocapsid protein<br>directly in anterior nasal swab samples<br>from individuals with signs and<br>symptoms of respiratory tract infection.<br>Symptoms of respiratory infections due<br>to SARS-CoV-2 and influenza can be | The Healgen Rapid Check COVID-<br>19/Flu A&B Antigen Test is a lateral<br>flow immunochromatographic<br>assay intended for the qualitative<br>detection and differentiation of<br>influenza A, and influenza B<br>nucleoprotein antigens and SARS-<br>CoV-2 nucleocapsid antigen<br>directly in anterior nasal swab<br>samples from individuals with signs<br>and symptoms of respiratory tract<br>infection. Symptoms of respiratory<br>infections due to SARS-CoV-2 and<br>influenza can be similar. This test is<br>for non-prescription home use by |

| | | | Table 1. Comparison of the Proposed Device, Predicate Device and Reference Devices | | |
|--|--|--|------------------------------------------------------------------------------------|--|--|
|--|--|--|------------------------------------------------------------------------------------|--|--|

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

Image /page/8/Picture/0 description: The image shows the logo for Osang Healthcare. The logo consists of the letters "OHC" in a bold, sans-serif font. Below the letters, the words "OSANG HEALTHCARE" are written in a smaller, sans-serif font. The logo is black and white.

| Specification | Proposed Device: | Predicate Device: |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | QuickFinder™ COVID-19/Flu<br>Antigen Self Test / QuickFinder™<br>COVID-19/Flu Antigen Pro Test | Heaglen Rapid Check COVID-<br>19/Flu A & B Antigen Test<br>DEN240029 |
| | similar. This test is for non-prescription<br>home use by individuals aged 14 years<br>or older testing themselves or adults<br>testing individuals aged 2 years or older.<br>All negative results are presumptive and<br>should be confirmed with an FDA-<br>cleared molecular assay when<br>determined to be appropriate by a<br>healthcare provider. Negative results do<br>not rule out infection with influenza,<br>SARS-CoV-2, or other pathogens.<br>Individuals who test negative and<br>experience continued or worsening<br>respiratory symptoms, such as fever,<br>cough, and/or shortness of breath,<br>should seek follow up care from their<br>healthcare provider.<br>Positive results do not rule out co-<br>infection with other respiratory<br>pathogens, and therefore do not<br>substitute for a visit to a healthcare<br>provider for appropriate follow-up. | individuals aged 14 years or older<br>testing themselves, or adults testing<br>individuals aged 2 years or older.<br>All negative results are presumptive<br>and should be confirmed with an<br>FDA-cleared molecular assay when<br>determined to be appropriate by a<br>healthcare provider. Negative<br>results do not rule out infection with<br>influenza, SARS-CoV-2 or other<br>pathogens. Individuals who test<br>negative and experience continued<br>or worsening respiratory symptoms,<br>such as fever, cough and/or<br>shortness of breath, should seek<br>follow-up care from their healthcare<br>provider. Positive results do not rule<br>out co-infection with other<br>respiratory pathogens, and<br>therefore do not substitute for a visit<br>to a healthcare provider or<br>appropriate follow-up. |
| | QuickFinder™ COVID-19/Flu Antigen<br>Pro Test<br>The QuickFinder™ COVID-19/Flu<br>Antigen Pro Test is a lateral flow<br>immunochromatographic assay intended<br>for the qualitative detection and<br>differentiation of influenza A and<br>influenza B nucleoprotein antigens and<br>SARS-CoV-2 nucleocapsid protein<br>directly in anterior nasal swab samples<br>from individuals with signs and<br>symptoms of respiratory tract infection.<br>Symptoms of respiratory infections due<br>to SARS-CoV-2 and influenza can be<br>similar. This test is for use by individuals<br>aged 14 years or older testing<br>themselves or adults testing individuals<br>aged 2 years or older.<br>All negative results are presumptive and<br>should be confirmed with an FDA-<br>cleared molecular assay when<br>determined to be appropriate by a<br>healthcare provider. Negative results do | |
| Specification | Proposed Device: | Predicate Device: |
| | QuickFinder™ COVID-19/Flu<br>Antigen Self Test / QuickFinder™<br>COVID-19/Flu Antigen Pro Test | Heaglen Rapid Check COVID-<br>19/Flu A & B Antigen Test<br>DEN240029 |
| | not rule out infection with influenza,<br>SARS-CoV-2, or other pathogens.<br>Individuals who test negative and<br>experience continued or worsening<br>respiratory symptoms, such as fever,<br>cough, and/or shortness of breath,<br>should seek follow up care from their<br>healthcare provider.<br>Positive results do not rule out co-<br>infection with other respiratory<br>pathogens, and therefor do not<br>substitute for a visit to a healthcare<br>provider for appropriate follow-up. | |
| Prescription Use or<br>Over the Counter | Over the counter (OTC) | Over the counter (OTC) |
| End User | Lay User or professional use | Lay User |
| Environment of<br>Use | Home or similar environment (e.g., point<br>of care facility) | Home or similar environment |
| Disease | COVID-19 and Influenza A and B | COVID-19 and Influenza A and B |
| Intended Use<br>Population | Symptomatic individuals 14 years of age<br>and older testing themselves and adults<br>testing individuals aged 2 years and<br>older within 4 days post symptom onset. | Symptomatic individuals 14 years<br>of age and older testing<br>themselves and adults testing<br>individuals aged 2 years and older<br>within 5 days post symptom onset. |
| Sample | Anterior nasal swab specimen | Anterior nasal swab specimen |
| Assay Principle | Lateral Flow | Lateral Flow |
| Qualitative or<br>Quantitative | Qualitative | Qualitative |
| Organism<br>detected | SARS-CoV-2<br>Influenza A and B | SARS-CoV-2<br>Influenza A and B |
| Format | Test cassette | Test cassette |
| Controls | Internal control | Internal control |
| Time to Result | 15 minutes | 15 minutes |
| Results | Positive, Negative, or Invalid | Positive, Negative, or Invalid |
| Interpretation | Visually read | Visually read |

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for Osang Healthcare. The logo consists of the letters "OHC" in a bold, sans-serif font. Below the letters, the words "OSANG HEALTHCARE" are written in a smaller, sans-serif font. The logo is black and white.

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the logo for OSANG HEALTHCARE. The logo consists of the letters "OHC" in a bold, sans-serif font. Below the letters, the words "OSANG HEALTHCARE" are written in a smaller, sans-serif font. The logo is black and white.

## Technological Characteristics

As shown in the Table 1 above, the proposed device, QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test, and the predicate device have the same intended use and similar indications for use. The proposed device, QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test and the predicate device have the same technological characteristics. Both devices are lateral flow immunoassays which are visually read and require no instrumentation or mobile applications. Both devices detect the SARS-CoV-2 nucleocapsid protein and the Influenza A and B nucleoprotein from a user collected anterior swab specimen from individuals with signs and symptoms of COVID-19 or Influenza.

## Performance Data

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the proposed device, QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test and the predicate device. The performance studies included:

## Limit of Detection:

#### Single Analyte LoD:

The Limit of Detection (LoD) of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test was determined using serial dilutions of one strain of UV inactivated SARS-CoV-2 (USA-WA1/202) and two live strains of Influenza A and Influenza B. Contrived samples were prepared by spiking the strain into pooled human neqative swab matrix (PNSM) obtained from healthy volunteers confirmed neqative by RT-PCR. The preliminary LoD initially determined by testing ten-fold serial dilution series of three (3) replicates was confirmed by testing twenty (20) replicates. The confirmed LoD for the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test is shown in Table 2 below.

| Virus Strain | Stock<br>Concentration<br>(TCID50/mL) | LoD<br>Concentration<br>(TCID50/mL) | TCID50/Swab | #Positive/<br>#Total<br>Tested | Percent<br>Detected<br>(%) |
|---------------------------------------------------|---------------------------------------|-------------------------------------|-------------|--------------------------------|----------------------------|
| SARS-CoV-2<br>(USA-<br>WA1/2020) | 3.16 x 106 | <b>1.58 x 103</b> | 7.90 x 101 | 20/20 | 100% |
| Influenza A<br>H1N1pdm09:<br>A/Victoria/4897/2022 | 2.02 x 105 | <b>2.02 x 102</b> | 1.01 x 101 | 20/20 | 100% |
| Influenza A<br>H3N2:<br>A/Darwin/6/2021 | 4.17 x 105 | <b>2.09 x 102</b> | 1.04 x 101 | 20/20 | 100% |
| Influenza B Victoria:<br>B/Washington/02/2019 | 3.16 x 105 | <b>3.16 x 103</b> | 1.58 x 102 | 20/20 | 100% |
| Influenza B<br>Yamagata:<br>B/Florida/4/2006 | 1.17 x 105 | <b>2.93 x 101</b> | 1.46 | 20/20 | 100% |

#### Table 2. I imit of Detection

## Co-spiked LoD:

After the single analyte LoDs were established for the device, co-spiked LoD equivalency testing with all three test analytes present in the sample, was conducted to characterize the

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for OSANG HEALTHCARE. The logo consists of the letters OHC in a bold, sans-serif font. Below the letters is the text "OSANG HEALTHCARE" in a smaller, sans-serif font. The logo is black and white.

performance with samples that contain more than one analyte at low concentrations. All analytes that were successfully detected by the device when co-spiked at their single analyte LoD, may be co-spiked into positive sample(s) used in the analytical studies.

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

The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test demonstrated co-spike equivalency for all analytes, SARS-CoV-2, Flu A, and Flu B, to their respective established single analyte 1x LoD. The confirmed co-spike LoD is shown in the Table 3 below.

| Virus | LoD | LoD<br>Concentration<br>(TCID50/mL) | LoD<br>Concentration<br>per Swab<br>(TCID50/mL) | # Positive<br>Replicates |
|---------------------------------------------------|--------|-------------------------------------|-------------------------------------------------|--------------------------|
| SARS-CoV-2<br>(USA-WA1/2020) | 1x LoD | $1.58 x 10^3$ | $7.90 x 10^1$ | 20/20 (100%) |
| Influenza A<br>H1N1pdm09:<br>A/Victoria/4897/2022 | 1x LoD | $2.02 x 10^2$ | $1.01 x 10^1$ | 20/20 (100%) |
| Influenza B<br>Yamagata:<br>B/Florida/4/2006 | 1x LoD | $2.93 x 10^1$ | 1.46 | 20/20 (100%) |

#### Table 3. 1x LoD Co-Spike Results

## Inclusivity (Analytical Reactivity):

Analytical reactivity for QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COV/D-19/Flu Antigen Pro Test was demonstrated using a selection of temporal, geographic and genetically diverse Influenza and SARS-CoV-2 strains. Individual virus strains were diluted in pooled negative swab matrix (PNSM) at 10-fold dilution and tested in triplicate. After a 10-fold break point was established testing two-fold dilutions points of the lowest positive 10-fold dilution was completed. The lowest 10-fold or 2-fold dilution that demonstrated three (3) positive replicates was identified. The reactivity of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test with the different virus strains is summarized below in Table 4 with the lowest concentration that returned 100% positive replicates.

| Table 4. Summary of QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID- | | | |
|---------------------------------------------------------------------------------------------------|--|--|--|
| 19/Flu Antigen Pro Test's reactivity with different virus strains of SARS-CoV-2, Flu A and Flu B. | | | |

| Virus | Virus Strain | Concentration | Units |
|------------|------------------------------------|---------------|-----------|
| SARS-CoV-2 | XBB 1.5 (Omicron) Heat Inactivated | $4.0 x 10^2$ | TCID50/mL |
| Flu A H1N1 | A/California/04/2009 | $2.8 x 10^3$ | TCID50/mL |
| Flu A H1N1 | A/Brisbane/02/2018 | $1.9 x 10^2$ | TCID50/mL |
| Flu A H1N1 | A/Michigan/45/2015 | $1.9 x 10^1$ | TCID50/mL |
| Flu A H1N1 | A/Guangdong-Moanan/SWL 1536/19 | $1.0 x 10^3$ | TCID50/mL |
| Flu A H1N1 | A/NY/03/2009 | $4.6 x 10^4$ | TCID50/mL |
| Flu A H1N1 | A/Indiana/02/2020 | $9.7 x 10^6$ | CEID50/mL |
| Flu A H1N1 | A/Wisconsin/588/2019 | $2.8 x 10^4$ | FFU/mL |

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for Osang Healthcare. The logo consists of the letters "OHC" in a bold, sans-serif font. Below the letters, the words "OSANG HEALTHCARE" are written in a smaller, sans-serif font. The logo is black and white.

| Virus | Virus Strain | Concentration | Units |
|----------------------------------|------------------------------------------|---------------|-----------|
| | A/Sydney/5/2021 | 6.0 x $10^3$ | TCID50/mL |
| | A/Hawaii/66/2019 | 7.4 x $10^7$ | CEID50/mL |
| | A/Wisconsin/67/2022 | 4.2 x $10^2$ | TCID50/mL |
| Flu A H3N2 | A/New York/21/2020 | 3.3 x $10^5$ | FFU/mL |
| | A/Tasmania/503/2020 | 1.3 x $10^5$ | FFU/mL |
| | A/Alaska/01/2021 | 3.8 x $10^4$ | FFU/mL |
| | A/Hong Kong/45/2019 | 3.8 x $10^4$ | FFU/mL |
| | A/Hong Kong/2671/2019 | 1.1 x $10^3$ | TCID50/mL |
| | A/Indiana/08/2011 | 8.1 x $10^2$ | TCID50/mL |
| Flu A H1N1 | A/Ohio/09/2015 | 1.4 x $10^6$ | CEID50/mL |
| Flu A H1N2 | A/Minnesota/19/2011 | 8.0 x $10^6$ | CEID50/mL |
| Flu A H5N1 | A/mallard/Wisconsin/2576/2009 | 4.0 x $10^6$ | CEID50/mL |
| | A/bovine/Ohio/B24OSU-439/2024 | 7.8 x $10^3$ | TCID50/mL |
| | A/duck/Guangxi/S11002/2024 | 1.7 x $10^6$ | EID50/mL |
| Flu A H5N6 | A/duck/Guangxi/S10888/2024 | 1.7 x $10^6$ | EID50/mL |
| Flu A H5N8 | A/goose/Liaoning/S1266/2024 | 1.7 x $10^6$ | EID50/mL |
| Flu A H7N3 | A/northernpintail/Illinois/10O53959/2010 | 2.8 x $10^6$ | CEID50/mL |
| Flu B Victoria Lineage | B/Brisbane/60/2008 | 1.6 x $10^0$ | TCID50/mL |
| | B/Colorado/06/2017 | 2.9 x $10^1$ | TCID50/mL |
| | B/Texas/02/2013 | 2.5 x $10^1$ | TCID50/mL |
| | B/Michigan/01/2021 | 1.4 x $10^4$ | TCID50/mL |
| Flu B Yamagata Lineage | B/Texas/06/2021 | 1.5 x $10^3$ | TCID50/mL |
| | B/Utah/08/2014 | 1.3 x $10^3$ | TCID50/mL |
| | B/Wisconsin/01/2010 | 1.8 x $10^2$ | TCID50/mL |
| Flu B Non-Victoria, non-Yamagata | B/Maryland/1/1959 | 3.4 x $10^3$ | CEID50/mL |

## NIBSC - WHO Standard Testing

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). The unitage of this material has an assigned value of 5,000 International Units of SARS-CoV-2 antigen per ampoule when reconstituted per instructions. 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 50 µL 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.

| Description | Source | NIBSC No. | Concentration<br>(IU/mL) | Concentration<br>IU/swab | # Positive<br>Results |
|----------------------------------------------------|----------------------------------------------------------------------|-----------------|--------------------------|--------------------------|-----------------------|
| WHO<br>International<br>Standard for<br>SARS-CoV-2 | National<br>Institute for<br>Biological<br>Standards and<br>Controls | NIBSC<br>21/368 | 1,000 IU/mL | 50 IU/swab | 20/20 |

Table 5: WHO International Standard

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for OSANG HEALTHCARE. The logo consists of the letters "OHC" in a bold, sans-serif font. Below the letters, the words "OSANG HEALTHCARE" are written in a smaller, sans-serif font. The logo is black and white.

## Competitive Interference:

Competitive interference testing (i.e., evaluation of potential for a high concentration of one target virus to interfere with detection of a low concentration of another target virus) for the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test was completed. The testing was performed with different combinations of low (3x LoD) and high concentrations of live Influenza A, live Influenza B and UV inactivated SARS-CoV-2 on the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test device to determine if the candidate device can detect target analytes across a variety of analyte concentrations. Refer to Table 6. No competitive interference/false positive results were observed for analytes not present in the sample.

| Combination | Viral Target in Sample | | | |
|-------------|------------------------|-------------|------------|-----------------|
| | Influenza A | Influenza B | SARS-CoV-2 | Results |
| 1 | High | 3x LoD | Negative | No interference |
| 2 | High | Negative | 3x LoD | No interference |
| 3 | High | 3x LoD | 3x LoD | No interference |
| 4 | 3x LoD | High | Negative | No interference |
| 5 | Negative | High | 3x LoD | No interference |
| 6 | 3x LoD | High | 3x LoD | No interference |
| 7 | 3x LoD | Negative | High | No interference |
| 8 | Negative | 3x LoD | High | No interference |
| 9 | 3x LoD | 3x LoD | High | No interference |

#### Table 6. Competitive Interference

## Cross Reactivity/Microbial Interference:

The cross-reactivity and potential microbial interference were evaluated by testing various microorganisms, viruses, and negative matrix with the QuickFinder™ COVID-19/Flu Antigen Self Test /QuickFinder™ COVID-19/Flu Antigen Pro Test to determine if other respiratory pathoqens/flora that could be present in the direct nasal swab samples could cause a false positive test result or interference with a true positive result. Each organism and virus were tested in three (3) replicates in the absence (cross reactivity) and presence (microbial interference) of heat-inactivated SARS-CoV-2, live Influenza A, and live Influenza B (3x co-spike equivalency LoD). No cross reactivity was observed for any of the organisms tested. No microbial interference was observed for any of the organisms tested. Refer to Table 7 below for a summary of results.

| Microorganism | Concentration | Units | Cross-<br>Reactivity | Microbial<br>Interference |
|------------------------|---------------|-----------|----------------------|---------------------------|
| Human coronavirus 229E | 1.58 x 105 | TCID50/mL | No | No |
| Human coronavirus OC43 | 7.00 x 105 | TCID50/mL | No | No |
| Human coronavirus NL63 | 7.05 x 104 | TCID50/mL | No | No |
| Human coronavirus HKU1 | 1.74 x 107 | GE/mL | No | No |
| MERS-coronavirus | 1.47 x 105 | TCID50/mL | No | No |

Table 7. Cross-reactivity/Microbial Interference Study Results

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the logo for OSANG HEALTHCARE. The logo consists of the letters "OHC" in a bold, sans-serif font. Below the letters, the words "OSANG HEALTHCARE" are written in a smaller, sans-serif font. The log…