(90 days)
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.
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.
- 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.
Here's a detailed description of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test
The acceptance criteria for the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test are primarily demonstrated through its clinical performance, comparing its results against a highly sensitive, FDA 510(k) cleared molecular assay. Additional analytical performance studies confirm the device's technical capabilities.
1. Table of Acceptance Criteria and Reported Device Performance
Clinical Performance Acceptance Criteria (Implicit from reported results):
While explicit acceptance criteria are not stated as numerical cutoffs in the document, these are the reported performance values that demonstrate the device's efficacy. From context, the reported PPAs and NPAs are likely what the FDA evaluated for establishing substantial equivalence.
| Performance Metric | Acceptance Criteria (Reported Performance) |
|---|---|
| SARS-CoV-2 (COVID-19) | |
| Positive Percent Agreement (PPA) | 90.6% (95% CI: 84.3%-94.6%) |
| Negative Percent Agreement (NPA) | 99.4% (95% CI: 98.5%-99.8%) |
| Influenza A | |
| Positive Percent Agreement (PPA) | 89.7% (95% CI: 79.2%-95.2%) |
| Negative Percent Agreement (NPA) | 98.8% (95% CI: 97.7%-99.4%) |
| Influenza B | |
| Positive Percent Agreement (PPA) | 86.0% (95% CI: 72.7%-93.4%) |
| Negative Percent Agreement (NPA) | 99.7% (95% CI: 99.0%-99.9%) |
| Usability (Human Factors Assessment) | |
| Critical tasks performed correctly | 92.5% |
| Non-critical tasks performed correctly | 88.0% |
| Overall Usability (Instructions clear/easy to follow) | 94% of subjects |
| Sample collection easy to follow | 100% of subjects |
| Sample collection easy to perform | 98% of subjects |
| No difficulty reading test results | 98% of subjects |
| Lay User Readability Assessment | |
| Overall accuracy of mock test interpretations | 93.6% (95% CI: 91.7-95.1%) |
2. Sample Size Used for the Test Set and Data Provenance
Test Set (Clinical Evaluation):
- Sample Size: A total of 788 evaluable subjects were enrolled.
- Data Provenance: The clinical study was conducted at six (6) sites in the United States from October 2023 to June 2024. The study was prospective, with samples collected by lay users from themselves or for a household member. Subjects were symptomatic individuals experiencing symptoms associated with COVID-19 or Influenza, within 4 days of symptom onset.
Test Set (Usability/Human Factors Assessment):
- Sample Size: 50 subjects participated (25 self-collecting and 25 lay-users collecting from another).
- Data Provenance: Conducted as part of the clinical study from October 2023 to November 2023, likely in the United States. Prospective, as subjects performed tasks in a simulated home environment.
Test Set (Lay User Readability Assessment):
- Sample Size: All 50 subjects who participated in the human factors assessment also interpreted mock devices.
- Data Provenance: Same as the Usability Assessment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the clinical test set was established by a highly sensitive molecular FDA 510(k) cleared SARS-CoV-2 assay and highly sensitive molecular FDA 510(k) cleared Influenza A and B assays. The document does not specify the number of experts or their qualifications within the context of establishing this ground truth (e.g., for interpreting the molecular assay results). The molecular assays themselves serve as the expert-level reference standard, implying specialized laboratory personnel and validated methods.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for conflicting results between the QuickFinder™ test and the reference molecular assays. The performance metrics (PPA, NPA) are calculated directly from the comparison. For the usability study, "study personnel or a healthcare provider" evaluated the subjects' performance, implying assessment by trained individuals, but a formal adjudication process (like 2+1) isn't detailed for disagreements, as it focuses on task performance rather than a diagnostic outcome.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study evaluating how much human readers improve with AI vs. without AI assistance. This device is a lateral flow immunochromatographic assay, a rapid visual test, and does not incorporate AI for result interpretation by human readers. The usability and readability studies assess the lay user's ability to interpret the test results, which is a form of human "reading," but not a comparative effectiveness study with AI assistance.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
The QuickFinder™ devices are standalone rapid visual tests that require human interpretation of the lines on the cassette. They are explicitly stated to "require no instrumentation or mobile applications." Therefore, the clinical performance data, while comparing to a molecular assay, represents the "standalone" performance of the test as interpreted by lay users (for the Self Test) or users (for the Pro Test) without an additional algorithm for interpretation.
7. The Type of Ground Truth Used
The primary ground truth used for evaluating the clinical performance of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test was a highly sensitive molecular FDA 510(k) cleared SARS-CoV-2 assay and highly sensitive molecular FDA 510(k) cleared Influenza A and B assays. This is considered the gold standard for detecting the presence of viral RNA/antigens.
For the analytical studies (LoD, Co-spiked LoD, Inclusivity, Interference, Hook Effect), the ground truth was established using known concentrations of specific viral strains (UV inactivated SARS-CoV-2 and live Influenza A and B) spiked into pooled human negative swab matrix (PNSM).
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. As this device is a rapid antigen test (lateral flow immunoassay) and likely relies on pre-calibrated reagents and visual signal detection rather than a machine-learning algorithm that requires a "training set" in the computational sense, such information would not typically be applicable or relevant in the same way it would be for AI/ML-based devices. The development of such assays involves extensive analytical validation using contrived and clinical samples, but these are generally referred to as validation sets rather than machine learning "training sets."
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" and its associated ground truth establishment methods (e.g., expert consensus, pathology labels, outcome data) are generally not applicable to a lateral flow immunoassay in the same way they would be for an AI/ML device. The analytical performance studies (LoD, inclusivity, interference) use precisely characterized viral material and reference standards to establish the "truth" for those controlled experiments. For the clinical validation, the ground truth was the results from the FDA-cleared molecular assays.
{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/FluAntigen 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 PRAStaff@fda.hhs.gov
"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.132, Anyangcheondong-RoDongan-GuAnyang Gyeonggi, Republic of Korea 14040Phone: 82-31-4600415 |
| Date Prepared: | January 10, 2025 |
| Contact Person: | Lisa Baumhardt, Sr. Medical Device Regulatory ConsultantHyman, Phelps, & McNamara, P.C.Phone: 202-424-9631Email: lbaumhardt@hpm.com |
| Secondary Contact | Seungyeob LeeOSANG LLC625 Fair Oaks Ave. Ste 360South Pasadena, CA 91030Phone: 213-800-1820Email: dan@osangllc.com |
| Identification of the Device | |
| Trade Name: | QuickFinder TM COVID-19/Flu Antigen Self TestQuickFinder TM COVID-19/Flu Antigen Pro Test |
| Common Name: | Multi-analyte respiratory virus antigen detection test |
| Classification Name | Multi-analyte respiratory virus antigen detection test21 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(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:QuickFinder™ COVID-19/FluAntigen Self Test / QuickFinder™COVID-19/Flu Antigen Pro Test | Predicate Device:Heaglen Rapid Check COVID-19/Flu A & B Antigen TestDEN240029 |
|---|---|---|
| Intended Use | Over-the-counter test to detect SARS-CoV-2 and Influenza A and B fromclinical specimens. | Over-the-counter test to detectSARS-CoV-2 and Influenza A andB from clinical specimens. |
| Indications forUse | QuickFinder™ COVID-19/Flu AntigenSelf TestThe QuickFinder™ COVID-19/FluAntigen Self Test is a lateral flowimmunochromatographic assay intendedfor the qualitative detection anddifferentiation of influenza A andinfluenza B nucleoprotein antigens andSARS-CoV-2 nucleocapsid proteindirectly in anterior nasal swab samplesfrom individuals with signs andsymptoms of respiratory tract infection.Symptoms of respiratory infections dueto SARS-CoV-2 and influenza can be | The Healgen Rapid Check COVID-19/Flu A&B Antigen Test is a lateralflow immunochromatographicassay intended for the qualitativedetection and differentiation ofinfluenza A, and influenza Bnucleoprotein antigens and SARS-CoV-2 nucleocapsid antigendirectly in anterior nasal swabsamples from individuals with signsand symptoms of respiratory tractinfection. Symptoms of respiratoryinfections due to SARS-CoV-2 andinfluenza can be similar. This test isfor 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/FluAntigen Self Test / QuickFinder™COVID-19/Flu Antigen Pro Test | Heaglen Rapid Check COVID-19/Flu A & B Antigen TestDEN240029 | |
| similar. This test is for non-prescriptionhome use by individuals aged 14 yearsor older testing themselves or adultstesting individuals aged 2 years or older.All negative results are presumptive andshould be confirmed with an FDA-cleared molecular assay whendetermined to be appropriate by ahealthcare provider. Negative results donot rule out infection with influenza,SARS-CoV-2, or other pathogens.Individuals who test negative andexperience continued or worseningrespiratory symptoms, such as fever,cough, and/or shortness of breath,should seek follow up care from theirhealthcare provider.Positive results do not rule out co-infection with other respiratorypathogens, and therefore do notsubstitute for a visit to a healthcareprovider for appropriate follow-up. | individuals aged 14 years or oldertesting themselves, or adults testingindividuals aged 2 years or older.All negative results are presumptiveand should be confirmed with anFDA-cleared molecular assay whendetermined to be appropriate by ahealthcare provider. Negativeresults do not rule out infection withinfluenza, SARS-CoV-2 or otherpathogens. Individuals who testnegative and experience continuedor worsening respiratory symptoms,such as fever, cough and/orshortness of breath, should seekfollow-up care from their healthcareprovider. Positive results do not ruleout co-infection with otherrespiratory pathogens, andtherefore do not substitute for a visitto a healthcare provider orappropriate follow-up. | |
| QuickFinder™ COVID-19/Flu AntigenPro TestThe QuickFinder™ COVID-19/FluAntigen Pro Test is a lateral flowimmunochromatographic assay intendedfor the qualitative detection anddifferentiation of influenza A andinfluenza B nucleoprotein antigens andSARS-CoV-2 nucleocapsid proteindirectly in anterior nasal swab samplesfrom individuals with signs andsymptoms of respiratory tract infection.Symptoms of respiratory infections dueto SARS-CoV-2 and influenza can besimilar. This test is for use by individualsaged 14 years or older testingthemselves or adults testing individualsaged 2 years or older.All negative results are presumptive andshould be confirmed with an FDA-cleared molecular assay whendetermined to be appropriate by ahealthcare provider. Negative results do | ||
| Specification | Proposed Device: | Predicate Device: |
| QuickFinder™ COVID-19/FluAntigen Self Test / QuickFinder™COVID-19/Flu Antigen Pro Test | Heaglen Rapid Check COVID-19/Flu A & B Antigen TestDEN240029 | |
| not rule out infection with influenza,SARS-CoV-2, or other pathogens.Individuals who test negative andexperience continued or worseningrespiratory symptoms, such as fever,cough, and/or shortness of breath,should seek follow up care from theirhealthcare provider.Positive results do not rule out co-infection with other respiratorypathogens, and therefor do notsubstitute for a visit to a healthcareprovider for appropriate follow-up. | ||
| Prescription Use orOver the Counter | Over the counter (OTC) | Over the counter (OTC) |
| End User | Lay User or professional use | Lay User |
| Environment ofUse | Home or similar environment (e.g., pointof care facility) | Home or similar environment |
| Disease | COVID-19 and Influenza A and B | COVID-19 and Influenza A and B |
| Intended UsePopulation | Symptomatic individuals 14 years of ageand older testing themselves and adultstesting individuals aged 2 years andolder within 4 days post symptom onset. | Symptomatic individuals 14 yearsof age and older testingthemselves and adults testingindividuals aged 2 years and olderwithin 5 days post symptom onset. |
| Sample | Anterior nasal swab specimen | Anterior nasal swab specimen |
| Assay Principle | Lateral Flow | Lateral Flow |
| Qualitative orQuantitative | Qualitative | Qualitative |
| Organismdetected | SARS-CoV-2Influenza A and B | SARS-CoV-2Influenza 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 | StockConcentration(TCID50/mL) | LoDConcentration(TCID50/mL) | TCID50/Swab | #Positive/#TotalTested | PercentDetected(%) |
|---|---|---|---|---|---|
| SARS-CoV-2(USA-WA1/2020) | 3.16 x 106 | 1.58 x 103 | 7.90 x 101 | 20/20 | 100% |
| Influenza AH1N1pdm09:A/Victoria/4897/2022 | 2.02 x 105 | 2.02 x 102 | 1.01 x 101 | 20/20 | 100% |
| Influenza AH3N2:A/Darwin/6/2021 | 4.17 x 105 | 2.09 x 102 | 1.04 x 101 | 20/20 | 100% |
| Influenza B Victoria:B/Washington/02/2019 | 3.16 x 105 | 3.16 x 103 | 1.58 x 102 | 20/20 | 100% |
| Influenza BYamagata:B/Florida/4/2006 | 1.17 x 105 | 2.93 x 101 | 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 | LoDConcentration(TCID50/mL) | LoDConcentrationper Swab(TCID50/mL) | # PositiveReplicates |
|---|---|---|---|---|
| SARS-CoV-2(USA-WA1/2020) | 1x LoD | $1.58 x 10^3$ | $7.90 x 10^1$ | 20/20 (100%) |
| Influenza AH1N1pdm09:A/Victoria/4897/2022 | 1x LoD | $2.02 x 10^2$ | $1.01 x 10^1$ | 20/20 (100%) |
| Influenza BYamagata: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(IU/mL) | ConcentrationIU/swab | # PositiveResults |
|---|---|---|---|---|---|
| WHOInternationalStandard forSARS-CoV-2 | NationalInstitute forBiologicalStandards andControls | NIBSC21/368 | 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-Reactivity | MicrobialInterference |
|---|---|---|---|---|
| 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 logo is black and white.
| SARS-coronavirus | 1.25 x 105 | PFU/mL | No | No |
|---|---|---|---|---|
| Adenovirus type 1 | 2.23 x 105 | TCID50/mL | No | No |
| Adenovirus type 7 | 1.58 x 105 | TCID50/mL | No | No |
| hMPV 27 Type B2 | 3.50 x 105 | TCID50/mL | No | No |
| Parainfluenza virus 1 | 2.00 x 105 | TCID50/mL | No | No |
| Parainfluenza virus 2 | 1.75 x 105 | TCID50/mL | No | No |
| Parainfluenza virus 3 | 7.00 x 105 | TCID50/mL | No | No |
| Parainfluenza virus 4b | 2.39 x 105 | TCID50/mL | No | No |
| Enterovirus type 68 | 2.23 x 105 | TCID50/mL | No | No |
| Respiratory syncytial virus A | 3.50 x 105 | TCID50/mL | No | No |
| Respiratory syncytial virus B | 2.29 x 105 | TCID50/mL | No | No |
| Rhinovirus | 7.05 x 104 | TCID50/mL | No | No |
| Haemophilus influenzae type b | 9.68 x 106 | CFU/mL | No | No |
| Streptococcus pneumoniae | 1.81 x 107 | CFU/mL | No | No |
| Streptococcus pyogenes | 7.50 x 107 | CFU/mL | No | No |
| Candida albicans | 1.21 x 107 | CFU/mL | No | No |
| Mycoplasma pneumoniae | 2.50 x 107 | CFU/mL | No | No |
| Chlamydia pneumoniae | 4.33 x 106 | IFU/mL | No | No |
| Legionella pneumophila | 6.50 x 106 | CFU/mL | No | No |
| Staphylococcus aureus | 2.60 x 108 | CFU/mL | No | No |
| Staphylococcus epidermidis | 9.00 x 107 | CFU/mL | No | No |
| Mycobacterium tuberculosis | 3.03 x 106 | CFU/mL | No | No |
| P. jiroveci - S. cerevisiae | 1.30 x 107 | CFU/mL | No | No |
| Corynebacterium xerosis | 2.30 x 107 | CFU/mL | No | No |
| Escherichia coli | 1.79 x 108 | CFU/mL | No | No |
| Lactobacillus acidophilus | 1.21 x 107 | CFU/mL | No | No |
| Moraxella catarrhalis | 2.50 x 108 | CFU/mL | No | No |
| Neisseria meningitidis | 3.43 x 106 | CFU/mL | No | No |
| Neisseria elongate | 2.68 x 108 | CFU/mL | No | No |
| Psuedomonas aeruginosa | 3.45 x 108 | CFU/mL | No | No |
| Streptococcus salivarius | 1.01 x 106 | CFU/mL | No | No |
| Measles | 8.48 x 105 | TCID50/mL | No | No |
| Mumps | 8.48 x 105 | TCID50/mL | No | No |
| Epstein Barr virus | 1.83 x 106 | CP/mL | No | No |
| Cytomegalovirus | 7.05 x 104 | TCID50/mL | No | No |
| Bordetella pertussis | 2.90 x 108 | CFU/mL | No | No |
| Pooled Negative Nasal Wash | N/A | N/A | No | No |
Exogenous and Endogenous Interfering Substances Study:
Thirty-two (32) potentially interfering substances were evaluated with the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test to verify if endogenous and exogenous substances that may be present in respiratory specimens interfere with the detection of SARS-CoV-2, Influenza A and Influenza B in the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test. Each substance was tested in three (3) replicates in the presence and absence of SARS-CoV-2, Influenza A, and Influenza B.
The positive (3x LoD co-spike pooled nasal wash (PNW) with UV inactivated SARS-CoV-2, and live influenza A and live influenza B) and negative specimens (un-spiked) were tested with the addition of the potentially interfering substances.
The performance of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™
{15}------------------------------------------------
Image /page/15/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.
COVID-19/Flu Antigen Pro Test was not affected by any of the potentially interfering substances listed in the table below at the concentration noted. With the exception of the FluMist Quadrivalent Live intranasal influenza virus vaccine, none of the substances cased a false-positive test result in un-spiked samples. While the presence of FluMist Quadrivalent Live intranasal influenza virus 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 also resulted in 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 detected all analytes at 0.05% w/v. Refer to Table 8 for the interfering substances evaluated.
| InterferingSubstance | Concentration | Cross-Reactivity(no analyte)(#pos/ #total) | Interference(3x co-spiked analyteLoD)(#pos/ #total) | ||||
|---|---|---|---|---|---|---|---|
| SARS-CoV-2 | Flu A | Flu B | SARS-CoV-2 | Flu A | Flu B | ||
| Human Whole Blood(EDTA tube) | 4% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Leukocytes | 2.85 x 106cells/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Throat lozenges(Menthol/Benzocaine) | 3.0 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Mucin (bovinesubmaxillary glandsType I-S) | 2.5 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Naso GEL (NeilMed) | 5% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Nasal gel (Zicam(Galphimia glauca,Histaniumhydrocloricum, Luffaoperculate, Sulfur)) | 1.25% v/v | 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 |
| Zicam Nasal spray(Galphimia glauca,luffa operculate) | 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 |
| Homeopathic allergyrelief | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| InterferingSubstance | Concentration | Cross-Reactivity(no analyte)(#pos/ #total) | Interference(3x co-spiked analyteLoD)(#pos/ #total) | ||||
| SARS-CoV-2 | Flu A | Flu B | SARS-CoV-2 | Flu A | Flu B | ||
| (Histaminumhydrochloricum) | |||||||
| TheraZinc ThroatSpray (Zinc) | 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, nasalointment (Mupirocin) | 10 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 corticosteroid(Triamcinolone) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Nasal corticosteroid(Dexamethasone) | 1mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Tamiflu (OseltamivirPhosphate) | 5 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| FluMist/FluMist | 15% v/v | 0/3 | 3/3 | 3/3 | 3/3 | 3/3 | 3/3 |
| Quadrivalent Liveintranasal influenzavirus vaccine | 1.5% v/v | 0/3 | 0/3 | 0/3 | NA | NA | NA |
| Zanamivir | 282 ng/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Remdesivir | 10 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Biotin | 3,500 ng/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Body and HandLotion | 0.5% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Body Lotion with1.2% 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 withAloe,62% ethyl alcohol | 5% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Hand Sanitizer withcream 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/v0.05% w/v | 0/3NA | 0/3NA | 0/3NA | 3/3 | 3/3 | 0/3 |
Table 8. Interfering Substances Study Results
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the logo for Osang Healthcare. The logo consists of the letters O, H, and C 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.
Hook Effect:
{17}------------------------------------------------
Image /page/17/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.
To ensure that a high concentration of SARS-CoV-2, Influenza A and Influenza B antigens do not interfere with a positive reaction in the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test, a hook effect study was conducted. No high dose hook effect was observed with the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test when high concentrations of SARS-CoV-2, Influenza A and Influenza B were tested as noted in Table 9 below.
| Analyte | Strain | Lineage | Concentration(TCID50/mL) | Concentration(TCID50/swab) |
|---|---|---|---|---|
| SARS-CoV-2 | USA-WA1/2020 | SARS-CoV-2 | 3.16 x 106 | 1.58 x 105 |
| Influenza A(H1N1) | A/Victoria/4897/2022 | H1N1 pdm09 | 2.02 x 105 | 1.01 x 104 |
| Influenza A(H3N2) | A/Darwin/6/2021 | H3N2 | 4.17 x 105 | 2.09 x 104 |
| Influenza B(Victoria) | B/Washington/02/2019 | Victoria | 3.16 x 106 | 1.58 x 105 |
| Influenza B(Yamagata) | B/Florida/04/2006 | Yamagata | 1.17 x 105 | 5.85 x 103 |
Table 9. High Dose Hook Effect
Stability:
Real Time Stability:
Three lots of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test were subjected to room temperature (30°C) at 45% relative humidity (RH). room temperature at 95% RH, and 2℃ at ambient humidity. The test panel comprised of negative clinical matrix, 1x LoD and 4x LoD of SARS-CoV-2, Flu A and Flu B viruses. 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 shelf life of up to 18 months. The shelf life will be updated as additional passing timepoints become available.
Open Kit Stabilitv:
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 (PNW) and five (5) co-spiked low positive samples (2x sinqle analyte LoD of SARS-CoV-2, Flu A, and Flu B co-spiked together into PNW). PNW was demonstrated to be equivalent to neqative nasal swab matrix equivalency study. Device packaging was opened, and testing was performed at zero (0) hours to establish a baseline. Thereafter the devices were stores for one (1) hour and two (2) hours at room temperature. All study data before and after storage of the open kits were 100% concordant with expected results.
Transport Stability:
Simulated winter and summer transport temperature conditions were used to evaluate the worstcase shipping and handling of components of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test over an extended period of time. The functional performance of the device is assessed by comparing the pre- (TO) and post-distribution (Td) result
{18}------------------------------------------------
Image /page/18/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.
of a test panel comprised of pooled negative nasal wash (PNW) samples and co-spiked low positive samples (3x single analyte LoD with SARS-CoV-2, Flu A, and Flu B, together in contrived PNW). All results were as expected for all timepoints.
Flex Studies:
To assess the robustness and risk of false results of the test when deviating from the IFU/QRI test steps, a series of flex studies were performed by testing QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test that assessed all major aspects of the test procedure (sample volume, reading time, swab extraction time and procedure (delay in mixing and addition of sample), sample hold time before and during processing) and variability of environmental test conditions when in use (lighting, disturbance during use, temperature and humidity stress conditions). Testing was performed with negative pooled nasal wash (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 various conditions as shown in Table 10.
The results demonstrate the robustness of the assay in the intended use condition and the assay does not present a significant risk of erroneous results when performed by a lay user and false results can be expected to be reasonably mitigated through labeling.
| Flex Studies | |
|---|---|
| Placement of the device on non-level surface | Temperature and Humidity Extremes |
| Swab mixing expression variability | Variety of Light Conditions |
| Sample volume variability | Open cassette pouch stability |
| Touching or moving test cassette during test | Sample stability |
| Result reading time | Winter/Summer Transport Conditions |
Table 10 Flov Studios
Precision Studies:
The lot-to-lot precision of the QuickFinder™ COVID-19/Flu Antigen Self Test/ QuickFinder™ COVID-19/Flu Antigen Pro Test was evaluated by using three (3) production lots.
For Study 1, a series of contrived samples were prepared as negative, low positive SARS-CoV-2 (2x LoD), low positive of Influenza A (2x LoD), low positive of Influenza B (2x LoD), SARS-CoV-2 and Influenza A (2x co-spike LoD). SARS-CoV-2 and Influenza B (2x co-spike LoD). Influenza A and B (2x co-spike LoD) and SARS-CoV-2, Influenza A and Influenza B (2x cospike LoD) using UV inactivated SARS-CoV-2, live influenza A and live influenza B isolates. Each blinded and randomized sample was tested on each device lot (total 3 lots) for each operator (two (2) operators) in two (2) runs per day over ten (10) days. The precision testing demonstrated there was no difference in results lot-to-lot and between operators. Refer to Table 11 for a summary of results of Study 1.
Study 2 was specifically conducted to further evaluate potential differences between lots. The study used neqative samples (without the virus analyte) and very low positive samples at 0.75x LoD, commonly referred to as a high negative sample. Samples were prepared near the C95 concentration for all three analytes and were randomized and blinded. 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 analyte and sample level (24 replicates for each analyte with each lot). Data from this testing are integrated into Table 11 below. The random errors of the testing procedure across different days and runs, paired with an operator's
{19}------------------------------------------------
Image /page/19/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.
ability to read the line intensity for samples with very low analyte concentration (commonly referred to as 'high neqative samples') is expected to confound lot-specific variability and to have a significant impact on the precision estimates for high negative samples such as the 0.75x LoD sample tested in this second part of the precision assessment. 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 concentration in the 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 x LoD of the test.
| Lot 1 | Lot 2 | Lot 3 | Total % | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Sample | N | Count* | % Agreement | Count* | % Agreement | Count* | % Agreement | Agreement | 95% CI |
| Negative | 240 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100% |
| Negative | 72 | 24/24 | 100% | 24/24 | 100% | 24/24 | 100% | 100% | 94.39-100% |
| 0.75xLoD | 72** | 18/24 | 75% | 14/24 | 58.3% | 17/24 | 70.8% | 68.1% | 56.6-77.7% |
| SARS-CoV-2 &Flu B | 72*** | 19/24 | 79.2% | 13/24 | 54.2% | 18/24 | 100% | 69.4% | 58.0-78.9% |
| 0.75xLoDFlu A | 72 | 15/24 | 62.5% | 23/24 | 95.8% | 17/24 | 70.8% | 76.4% | 65.4-84.7% |
| 2x LoDSARS-CoV-2 | 240 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100% |
| 2x LoDFlu A | 240 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100% |
| 2x LoDFlu B | 240 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100% |
| 2x LoDSARS-CoV-2 &Flu A | 240 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100% |
| 2x LoDSARS-CoV-2 &Flu B | 240 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100% |
| 2x LoDFlu A &Flu B | 240 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100% |
| 2x LoDSARS-CoV-2 &Flu A &Flu B | 240 | 80/80 | 100% | 80/80 | 100% | 80/80 | 100% | 100% | 96.9-100% |
| Table 11. Summary Results for Lot-to-Lot Precision Study (Operators Combined) | ||||
|---|---|---|---|---|
*The total number of replicates included in this table is different sample concentrations due to the study being performed in two parts. Please refer the study description above for additional details.
**SARS-CoV-2 Result
***Influenza B Result
Clinical Evaluation:
{20}------------------------------------------------
Image /page/20/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.
A performance of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test was compared to a SARS-CoV-2 molecular assay and an Influenza A and B molecular study in a prospective clinical study completed at six (6) sites in the United States from October 2023 to June 2024. Samples were collected by lay users from themselves or collected for a household member. A total of 788 evaluable subjects (58.6% female and 41.4% male) were enrolled and each were currently experiencing symptoms associated with COVID-19 or Influenza, within 4 days of symptom onset. The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test detected SARS-CoV-2 with a Positive Percent Agreement (PPA) of 90.6% and a Negative Percent Agreement (NPA) of 99.4% in symptomatic individuals as compared to a highly sensitive molecular FDA 510(k) cleared SARS-CoV-2 assay. The QuickFinder™ COVID-19/Flu Antiaen Self Test / QuickFinder™ COVID-19/Fly Antigen Pro Test detected Influenza A with a Positive Percent Agreement (PPA) of 89.7% and a Negative Percent Agreement (NPA) of 98.8% as compared to a highly sensitive molecular FDA 510(k) cleared Influenza A assay. The QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test detected Influenza B with a Positive Percent Agreement (PPA) 86.0% and a Negative Percent Agreement (NPA) of 99.7% in symptomatic individuals as compared to a highly sensitive molecular FDA 510(k) cleared Influenza B assay. Results are provided in Tables 13 - 16 below. The subject demographics are provided in Table 12 below.
| Subjects (by lay-usercollection and testing)(N=111) | Self-collecting andtesting (N=677) | Overall (N=788) | |
|---|---|---|---|
| Mean (SD) | 11.1 (12.1) | 38.4 (16.3) | 34.4 (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 | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Alaskan | |||
| Native | |||
| Asian | 0 (0.0%) | 11 (1.6%) | 11 (1.4%) |
| Black or African | 4 (3.6%) | 54 (8.0%) | 58 (7.4%) |
| American | |||
| Native | 0 (0.0%) | 5 (0.7%) | 5 (0.6%) |
| Hawaiian/Pacific | |||
| Islander |
Table 12. Subject Demographics
{21}------------------------------------------------
Image /page/21/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.
| Subjects (by lay-usercollection and testing)(N=111) | Self-collecting andtesting (N=677) | Overall (N=788) | |
|---|---|---|---|
| White | 100 (90.1%) | 596 (88.0%) | 696 (88.3%) |
| Unknown/Prefer notto answer | 0 (0.0%) | 2 (0.3%) | 2 (0.3%) |
| Other (Mixedrace/biracial) | 7 (6.3%) | 9 (1.3%) | 16 (2.0%) |
Table 13. QuickFinder™ COVID-19/Flu Antigen Self Test /QuickFinder™ COVID-19/Flu Antigen Pro Test Performance Compared to SARS-CoV-2 Molecular Assay
| QuickFinder™ | Comparator | Total | |
|---|---|---|---|
| COVID-19/FluAntigen Self Test/Pro Test | Positive | Negative | |
| Positive | 116 | 4 | 120 |
| Negative | 12 | 656 | 668 |
| Total | 128 | 660 | 788 |
Positive Percent Agreement = (116/128) x 100% = 90.6% (95% Cl: 84.3%-94.6%) Negative Percent Agreement = (656/660) x 100% = 99.4% (95% Cl: 98.5%-99.8%)
Table 14. QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test Cumulative PPA results by Days Post Symptom Onset (DPSO) for SARS-CoV-2.
| Days PostSymptomOnset | Number ofSubjectsSamplesTested | QuickFinder™COVID-19/FluAntigen SelfTest/ Pro TestPositives* | ComparatorPositives | PPA |
|---|---|---|---|---|
| Day 0 | 19 | 0 | 0 | N/A |
| Day 1 | 180 | 27 | 31 | 87.1% |
| Day 2 | 274 | 39 | 45 | 86.7% |
| Day 3 | 185 | 32 | 33 | 97.0% |
| Day 4 | 130 | 18 | 19 | 94.7% |
| Total | 788 | 116 | 128 | 90.6% |
*NOTE: Four false positives yielded a false positive result on the QuickFinder™ COVID-19/Flu Antigen Self Test/ QuickFinder™ COVID-19/Flu Antigen Pro Test and were excluded from the analysis above.
| Table 15. QuickFinder™ COVID-19/Flu Antigen Self Test /QuickFinder™ COVID-19/Flu | |
|---|---|
| Antigen Pro Test Performance Compared to Influenza A Molecular Assay |
| QuickFinder™COVID-19/FluAntigen SelfTest/Pro Test | Comparator | Total | |
|---|---|---|---|
| Positive | Negative | ||
| Positive | 52 | 9 | 61 |
{22}------------------------------------------------
Image /page/22/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.
| Negative | 6 | 721 | 727 |
|---|---|---|---|
| Total | 58 | 730 | 788 |
Positive Percent Agreement = (52/58) x 100% = 89.7% (95% Cl: 79.2%-95.2%) Negative Percent Agreement = (721/730) x 100% = 98.8% (95% Cl: 97.7%-99.4%)
Table 16. QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test Performance Compared to Influenza B Molecular Assay
| QuickFinder™COVID-19/FluAntigen Self Test/Pro Test | Comparator | Total | |
|---|---|---|---|
| Positive | Negative | ||
| Positive | 37 | 2 | 39 |
| Negative | 6 | 743 | 749 |
| Total | 43 | 745 | 788 |
Positive Percent Agreement = (37/43) x 100% = 86.0% (95% Cl: 72.7%-93.4%) Negative Percent Agreement = (743/745) x 100% = 99.7% (95% Cl: 99.0%-99.9%)
Clinical Sensitivity:
Refer to Clinical Evaluation section (above) for the clinical validation. The PPA for the test for each analyte is as follows:
SARS-CoV-2: 90.6% (95% CI: 84.3%-94.6%) Flu A: 89.7% (95% Cl: 79.2%-95.2%) Flu B: 86.0% (95% Cl: 72.7%-93.4%)
Clinical Specificity:
Refer to the Clinical Evaluation section (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%) |
Usability Assessment:
A usability study was conducted to evaluate the usability of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test and to evaluate the labeling and comprehension of the QRI when performed by lay users in a simulated home environment. The study was conducted as part of the clinical study from October 2023 to November 2023. Fifty subjects (including subjects that self-collected and subjects collecting a sample and performing the testing on another subject (child or adult), participated in the human factors assessment where the study personnel or a healthcare provider evaluated the subject/tester's ability to correctly prepare the test components for testing, collect a sample, perform the test, and interpret the test results. All subjects participating in the human factors assessment also completed a labeling and comprehension questionnaire and were provided with a mock panel with different test results for interpretation. The demographics of the usability study are shown below in Table 17.
{23}------------------------------------------------
Image /page/23/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.
| Lay-user (Tester collectionand testing)(N=25) | Self-collecting andtesting (N=25) | Overall (N=50) | |
|---|---|---|---|
| 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] |
| Age Group | |||
| ≥2-<14 years of age | 20 (80%) | 0 (0%) | 20 (40%) |
| 14-24 years of age | 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%) |
| Sex at Birth | |||
| Female | 11 (44%) | 17 (68%) | 28 (56%) |
| Male | 14 (56%) | 8 (32%) | 22 (44%) |
aphics of Usability Study Population
The human factors assessment portion of the study was competed per the protocol. Fifty (50) subjects (25 self-collecting and 25 lay-users collecting from another) were enrolled in the human factors assessment. Evaluation of the human user experience indicated high usability of the QuickFinder™ COVID-19/Flu Antigen Self Test/ QuickFinder™ COVID-19/Flu Antigen Pro Test. 94% of the subjects who participated found the instructions to be clear and easy to follow with 100% of the subjects finding the sample collections easy to follow. 98% of the subjects found sample collection easy to perform, as well as having no difficulty reading the test results. Overall, 92.5% of all critical tasks associated with sample collection and running the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test were performed correctly. Additionally, 88% of all non-critical tasks were performed correctly. The human factors assessment met the targets for percentage of critical and non-critical tasks performed correctly as shown in the Table 18 below.
| Steps | Tasks performedcorrectly | Total number oftasks | Percentage oftasks |
|---|---|---|---|
| Critical | 370 | 400 | 92.5% |
| Non-Critical | 176 | 200 | 88.0% |
| Total | 546 | 600 | 91.0% |
Table 18. Critical vs Non-Critical Tasks Correctly Performed
Lay User Readability Assessment:
All fifty (50) subjects who participated in the human factors assessment (Usability Assessment) also interpreted a panel of mock devices with various results that reflected the test concentrations at 1.9x and 5x the limits of detection (LoD) in a blinded and random fashion. Each panel of mock tests included 16 tests with various negative and positive results for each analyte. The percentage of human factors subjects with vision impairment is 14% (7/50). The vision impairments encountered in the study subjects are listed in the Table 19 with their
{24}------------------------------------------------
Image /page/24/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.
respective frequency of occurrence.
Table 19. Vision Impairment of Readability Study Subjects
| Type of Vision Impairment | # of Study Subjects | Percentage of total humanfactors subjects with visionimpairment (N=50) |
|---|---|---|
| Near sightedness only (with lensprescription) | 1 | 2% |
| Far sightedness only (with lensprescription) | 3 | 6% |
| Astigmatism | 2 | 4% |
| Glaucoma | 1 | 2% |
| Total Subjects with Vision Impairment | 7 | 14% |
The comparison of the result interpretation data between lay users with and without visual impairment is included in Table 20 below.
| Accuracy of Mock Test Interpretations [%] | ||
|---|---|---|
| Mock Results Type | Subjects without visionimpairment (N=43) | Subjects with visionimpairment (N=7) |
| 1.9x - Flu A+ & Flu B+ | 100.0% | 85.7% |
| 1.9x - COV-19+/Flu A+ | 81.4% | 100.0% |
| 1.9x - COV-19+/Flu A+ & Flu B+ | 100.0% | 100.0% |
| 1.9x - COV-19+/Flu B+ | 81.4% | 100.0% |
| 1.9x - COV+ | 100.0% | 100.0% |
| 1.9x - Flu A+ | 93.0% | 100.0% |
| 1.9x - Flu B+ | 93.0% | 100.0%* |
| 5x - Flu A+ & Flu B+ | 97.7% | 100.0% |
| 5x - COV-19+/Flu A+ | 86.0% | 100.0% |
| 5x - COV-19+/Flu A+ & Flu B+ | 100.0% | 100.0%* |
| 5x - COV-19+/Flu B+ | 88.4% | 85.7% |
| 5x - COV+ | 95.3% | 100.0% |
| 5x - Flu A+ | 93.0% | 100.0% |
| 5x - Flu B+ | 93.0% | 85.7% |
| Invalid | 93.0% | 100.0% |
| Negative | 93.0% | 100.0% |
| Total | 93.0% | 95.5% |
Table 20. Lay User Readability Study Results
*Subject OSC02-007 interpretation for these samples was removed from the analysis (N=6).
The overall accuracy of the results interpreted by the lay users 93.6% (747/798): 95% Cl (91.7-95.1%).
Variant Monitoring Plan:
To determine whether the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™
{25}------------------------------------------------
Image /page/25/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.
COVID-19/Flu Antigen Pro Test can detect newly emerging variants, and/or to assess whether new mutations care impacting analytical sensitivity of the test performance, the Sponsor provided a variant monitoring plan in accordance with the Special Controls established for the device.
Risk Analysis:
A comprehensive risk analysis of the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test included identification of potential hazards, 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 error that could adversely affect system performance were identified and mitigated through 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 device.
Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision. Based on the comparison of technological features and intended use, and as a result of the non-clinical performance testing completed on OSANG's QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test, the proposed device does not raise new questions of safety and effectiveness and supports the conclusion that the proposed device is substantially equivalent to the predicate device. The results of non-clinical and clinical testing demonstrate the device is as safe, as effective and performs as well as or better than the predicate device. OSANG has demonstrated that the proposed device complies with applicable Special Controls for over the counter (OTC) test to detect SARS-CoV-2 and Influenza A and B from clinical specimens therefore the QuickFinder™ COVID-19/Flu Antigen Self Test / QuickFinder™ COVID-19/Flu Antigen Pro Test can be found substantially equivalent to the predicate device.
N/A