Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a visually read lateral flow immunoassay, which relies on chemical reactions and visual interpretation, not AI/ML for result determination. The summary explicitly states "visually read" and describes the physical components and process of a standard lateral flow test. There are no mentions of AI, ML, image processing, or software analysis of the results.

Therapeutic

No
The device is an in vitro diagnostic test for detecting SARS-CoV-2 antigen, not a treatment or therapeutic device. The intended use explicitly states it should not be used as the sole basis for treatment.

Diagnostic

Yes
The device is described as an "immunoassay test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen" and states "The device is for in vitro diagnostic use only," which confirms its purpose as a diagnostic tool.

SaMD (Software as a Medical Device)

No

The device is a lateral flow immunoassay test kit that includes physical components such as a test cassette, tube with extraction buffer, and swab. It is not solely software.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Device Description" section explicitly states: "The device is for in vitro diagnostic use only."
Intended Use: The "Intended Use / Indications for Use" describes the device as a test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens. This is a diagnostic purpose.
Method: The device uses a "lateral flow immunoassay test," which is a common method for in vitro diagnostic tests.
Specimen Type: It analyzes "anterior nasal swab specimens," which are biological samples collected from the body for diagnostic testing.
Purpose: The purpose is to identify the presence of a specific marker (SARS-CoV-2 nucleocapsid protein antigen) to aid in the diagnosis of COVID-19.

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

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a visually read lateral flow immunoassay test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.

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. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

The performance characteristics for SARS-CoV-2 were established from April, 2023 to February, 2024 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

Product codes

QYT

Device Description

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a lateral flow immunoassay intended for non-prescription home use qualitative detection of nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first five (5) days of symptom onset. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with two lines: a test line (T line) and a control line (C line).

The device is for in vitro diagnostic use only.

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) consists of the following components:

Tube Holder (located in kit box)
Test Cassette ●
Tube (pre-filled extraction buffer) ●
Swab ●
Quick Reference Instructions ●

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior nasal swab specimens

Indicated Patient Age Range

individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

Intended User / Care Setting

non-prescription home use by individuals, At home or similar place

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

Not Found

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

A prospective study was performed in which one thousand and fifty-three (1053) direct anterior nasal swab specimens were sequentially enrolled (between April 2023 and February 2024) and tested fresh with the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method). The samples were collected from symptomatic patients suspected of infection with respiratory symptoms, at nine (9) clinical sites. Subjects performed testing on selfcollected swab samples in age groups 14 and older, and adult collected samples for age groups 2-13, in a simulated at-home environment. To be enrolled in the study, patients had to present at the participating study site with signs and symptoms of respiratory infection generally observed from SARS-CoV-2 during the study period. Two anterior nasal swab specimens were collected from each patient: one swab was collected by a healthcare professional and sent for testing using an FDA-cleared highly sensitive molecular comparator method, and the other swab was self-collected and tested immediately with the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) per the test procedure. Out of 1053 enrolled subjects, there were 1032 evaluable subjects within 5 days of symptom onset (DPSO).

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

Non-clinical Performance
5.1 Lot-to-Lot Precision
Precision was assessed by measuring repeatability using three levels of samples including negative samples, weak positive sample and a positive samples were prepared in negative clinical nasal swab matrix (NCM), blinded and randomized. 50uL were pipetted onto each swab and swabs were processed per the IFU. The following results were obtained from three kit lots testing each sample in duplicate per run by three operators and two runs per day over 20 days (3 lots × 3 operators × 2 replicates/sample × 2 runs/day/operator × 20 days). A total of 720 tests were run per panel member.

In addition, a supplemental precision study was conducted testing negative samples and a sample below the LoD (0.9 x LoD) to demonstrate potential lot variability. These samples were tested with three lots by two operators for two replicates per run and two run per day over three days (3 lots × 2 operators × 2 replicates/sample × 2 runs/day/operator × 3 days).

Sample Level: Negative, Total: 720/720 (100%)
Sample Level: Weak positive (1.5 x LoD), Total: 720/720 (100%)
Sample Level: Positive (3 x LoD), Total: 720/720 (100%)
Sample Level: Negative, Total: 72/72 (100%)
Sample Level: 0.9x LoD SARS-CoV-2, Total: 64/72 (88.89%)

5.2 Analytical Sensitivity: Limit of Detection (LoD)
The Limit of Detection (LoD) of the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was determined by evaluating different dilutions of two (2) variants of inactivated SARS-CoV-2 in pooled negative nasal swab matrix. A 10-fold dilution series was made to determine the preliminary LoD, which was measured using three (3) device lots in triplicate measurements (n=3/lot). 50uL were pipetted onto each swab and swabs were processed per the IFU. The LoD was confirmed using 20 replicates for each of the same three (3) lots. The lowest viral concentration that was detected greater than or equal to 95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive) was determined to be the LoD for that strain. The LoD was the same for all three lots tested.

Variant: Original, Virus Strain: USA-WA1/2020, LoD (TCID50/mL): 1.0 x 10^4
Variant: Omicron BA.5, Virus Strain: USA/COR-22-063113/2022, LoD (TCID50/mL): 3.33 x 10^3

WHO Standard Testing

WHO Standard: SARS-CoV-2 antigen, LoD (IU/mL): 2.00x10^2, LoD (IU/swab): 10

5.3 Inclusivity (Analytical Reactivity)
Analytical reactivity for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was demonstrated using six (6) additional strains of SARS CoV-2 virus and one (1) SARS-CoV-2 JN.1 clinical specimen, in an LoD-like study. The analytical reactivity of the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) with the variants is shown in the table below:

Variant: Alpha, Virus Strain: England/204820464/2020, Lowest Reactivity Concentration: 1.0 x 10^3 TCID50/mL
Variant: Beta, Virus Strain: South_Africa/KRISP-K005325/2020, Lowest Reactivity Concentration: 1.0 x 10^3 TCID50/mL
Variant: Gamma, Virus Strain: Japan/TY7-503/2021, Lowest Reactivity Concentration: 1.0 x 10^3 TCID50/mL
Variant: Delta, Virus Strain: USA/PHC658/2021, Lowest Reactivity Concentration: 1.0 x 10^2 TCID50/mL
Variant: Omicron B.1.1.529, Virus Strain: USA/MD-HP20874/2021, Lowest Reactivity Concentration: 1.0 x 10^2 TCID50/mL
Variant: Omicron BA.2.3, Virus Strain: USA/MD-HP24556/2022, Lowest Reactivity Concentration: 3.33 x 10^2 TCID50/mL
Variant: JN.1, Virus Strain: Clinical specimen, Lowest Reactivity Concentration: Ct=27.9 (2.28 x 10^4 GE/mL)

5.4 Analytical Specificity
Microorganism Cross-Reactivity and Microbial Interferences
30 microorganisms were tested in negative clinical nasal swab matrix and pooled nasal wash. Each microorganism was tested in three (3) replicates in the absence and presence of SARS-CoV-2 (USA/COR-22-063113/2022) at 2xLoD. None of the organisms and viruses evaluated demonstrated cross-reactivity or microbial interference in this assay at the concentrations tested. All 0/3 for cross-reactivity and 3/3 for interference were observed across all tested microorganisms.

Interfering Substances
Forty-two (42) potentially interfering substances were tested, diluted in negative nasal swab matrix. Each substance was tested in three (3) replicates in the absence and presence of heat-inactivated SARS-CoV-2 (isolate USA/COR-22-063113/2022) at 2xLoD. The endogenous and exogenous interfering substances do not cross-react or interfere with the performance of the device at the concentrations tested. All 0/3 for cross-reactivity and 3/3 for interference were observed across all tested substances.

5.5 High Dose Hook Effect
No high-dose hook effect was observed when Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was used to test specimens containing SARS-CoV-2 Omicron Lineage BA.5 (hCoV19/USA/COR-22-063113/2022) viral concentration as high as 1.98 x 10^6 TCID50/mL.

5.6 Usability and User Comprehension Studies
Usability Study: A usability study was conducted with 30 participants (aged 14 years and older and caregiver-child/adult pairs) observed during testing. All subjects completed the testing and were assessed for understanding via a questionnaire. The results were deemed acceptable, demonstrating easy-to-follow instructions.

Readability Study: Evaluated lay users' (50 participants) ability to interpret test results with low positive samples in a simulated home environment. Participants interpreted two panels of 5 test devices with varying concentrations (Negative, 1.5xLoD, 5xLoD, Invalid).

Sample Level: Negative, Number of Test Results Across all Participants: 150, Number of Correct Interpretation: 146, Observed Performance (%): 97.33%
Sample Level: 1.5xLoD, Number of Test Results Across all Participants: 150, Number of Correct Interpretation: 140, Observed Performance (%): 93.33%
Sample Level: 5xLoD, Number of Test Results Across all Participants: 100, Number of Correct Interpretation: 100, Observed Performance (%): 100%
Sample Level: Invalid, Number of Test Results Across all Participants: 100, Number of Correct Interpretation: 100, Observed Performance (%): 100%

Clinical studies (6)
A prospective study was performed with 1053 direct anterior nasal swab specimens (1032 evaluable subjects within 5 days of symptom onset), collected from symptomatic patients at nine (9) clinical sites between April 2023 and February 2024.

Positive Percent Agreement (PPA): 84.38% (108/128) (95% CI: 77.10% - 89.65%)
Negative Percent Agreement (NPA): 99.67% (901/904) (95% CI: 99.03% - 99.89%)

Clinical Performance in Subjects on Days Post Symptoms Onset:

Days Since Symptom Onset 0: PPA 100.00% (5/5), NPA 100.00% (19/19)
Days Since Symptom Onset 1: PPA 90.91% (20/22), NPA 100.00% (153/153)
Days Since Symptom Onset 2: PPA 82.35% (28/34), NPA 99.69% (318/319)
Days Since Symptom Onset 3: PPA 83.33% (25/30), NPA 99.13% (228/230)
Days Since Symptom Onset 4: PPA 86.36% (19/22), NPA 100.00% (116/116)
Days Since Symptom Onset 5: PPA 73.33% (11/15), NPA 100.00% (67/67)
Total: PPA 84.38% (108/128), NPA 99.67% (901/904)

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

Positive Percent Agreement (PPA): 84.38% (108/128) (95% CI:77.10% - 89.65%)
Negative Percent Agreement (NPA): 99.67% (901/904) (95% CI:99.03% - 99.89%)

Predicate Device(s)

K230828

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

N/A

Summary

0

September 30, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Guangzhou Wondfo Biotech Co., Ltd. Xiao Kaiyu Regulatory Affairs Manager No.8 Lizhishan Road, Science City, Huangpu District Guangzhou, 510663 China

Re: K241317

Trade/Device Name: Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) Regulation Number: 21 CFR 866.3984 Regulation Name: Over-The-Counter Test To Detect SARS-Cov-2 From Clinical Specimens Regulatory Class: Class II Product Code: QYT Dated: Mav 9, 2024 Received: May 10, 2024

Dear Xiao Kaiyu:

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.

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"

1

(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 OS 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 Rue"). 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-devices/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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

2

Sincerely,

Silke Schlottmann Digitally signed by Silke
Schlottmann Digitally Schlottmann -S -ટ Date: 2024.09.30 13:17:20 -04'00'

Silke Schlottmann, Ph.D. Deputy Assistant Director Bacteriology Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241317

Device Name

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

Indications for Use (Describe)

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a visually read lateral flow immunoassay test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.

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. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

The performance characteristics for SARS-CoV-2 were established from April, 2023 to February, 2024 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

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.

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."

4

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

510(k) Summary

Applicant Information

Submitter Name	Guangzhou Wondfo Biotech Co., Ltd.
Address	No.8 Lizhishan Road, Science City, Huangpu District, 510663
Guangzhou, Guangdong, China
Contact Person	Kaiyu Xiao
Senior Regulatory Affairs Manager
Tel: +86-15005196892
E-mail: kaiyu.xiao@wondfo.com.cn
Date Prepared	September 28, 2024

Device Information

Trade Name	Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
Common Name	2019-nCoV Antigen Test
Classification	Class II
Classification
Name	Over-the-counter covid-19 antigen test
Product Code	QYT
Regulation
Number	21 CFR 866.3984
Review Panel	Microbiology

Legally Marketed Predicate Device

Trade Name	Flowflex COVID-19 Antigen Home Test
510(k) Number	K230828
Product Code	QYT
Review Panel	Microbiology

5

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

1 Device Description

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a lateral flow immunoassay intended for non-prescription home use qualitative detection of nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19 within the first five (5) days of symptom onset. Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with two lines: a test line (T line) and a control line (C line).

The device is for in vitro diagnostic use only.

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) consists of the following components:

. Tube Holder (located in kit box)
Test Cassette ●
Tube (pre-filled extraction buffer) ●
Swab ●
Quick Reference Instructions ●

Indications for Use 2

The Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is a visually read lateral flow immunoassay test intended for the qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID-19.

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. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not rule out SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.

Positive results do not rule out co-infection with other respiratory pathogens.

This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.

6

Guangzhou Wondfo Biotech Co., Ltd. 510(k) Summary Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

The performance characteristics for SARS-CoV-2 were established from April 2023 to February 2024 when SARS-CoV-2 Omicron was dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.

3 Comparison to Predicate Device

The Wondfo 2019-nCoV Antigen Test is substantially equivalent in principle and performance to Flowflex COVID-19 Antigen Home Test (K230828) which had been cleared by FDA. The comparison to predicate device is as follows the table below:

| Item | Predicate Device
Flowflex COVID-19 Antigen
Home Test (K230828) | Candidate Device
Wondfo 2019-nCoV Antigen Test
(Lateral Flow Method) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended
Use/
Indications
for Use | The Flowflex COVID-19
Antigen Home Test is a visually
read lateral flow immunoassay
device intended for the rapid,
qualitative detection of SARS-
CoV-2 virus nucleocapsid
protein antigen directly in
anterior nasal swab specimens
from individuals with signs and
symptoms of COVID-19 within
the first 6 days of symptom
onset. | The Wondfo 2019-nCoV Antigen Test
(Lateral Flow Method) is a visually
read lateral flow immunoassay test
intended for the qualitative detection
of SARS-CoV-2 virus nucleocapsid
protein antigen directly in anterior
nasal swab specimens from
individuals with signs and symptoms
of COVID-19. |
| | 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. | 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. |
| | The Flowflex COVID-19
Antigen Home Test does not
differentiate between SARS-
CoV and SARS-CoV-2. | All negative results are presumptive.
Symptomatic individuals with an
initial negative test result must be re-
tested once between 48 and 72
hours after the first test using either
an antigen test or a molecular test for
SARS-CoV-2. Negative results do
not rule out SARS-CoV-2 infections
or other pathogens and should not be
used as the sole basis for treatment.
Positive results do not rule out co-
infection with other respiratory
pathogens. |
| | All negative results are
presumptive. Symptomatic
individuals with an initial
negative test result must be re-
tested once between 48 and 72 | |
| | hours after the first test using
either an antigen test or a
molecular test for SARS-CoV-2.
Negative results do not
preclude SARS-CoV-2
infections or other pathogens
and should not be used as the
sole basis for treatment.
Positive results do not rule out
co-infection with other
respiratory pathogens.
This test is not a substitute for
visits to a healthcare provider
or appropriate follow-up and
should not be used to
determine any treatments
without provider supervision.
Individuals who test negative
and experience continued or
worsening COVID-19 like
symptoms, such as fever,
cough and/or shortness of
breath, should seek follow up
care from their healthcare
provider.
The performance
characteristics for SARS-CoV-2
were established from
December 2022 to March 2023
when SARS-CoV-2 Omicron
was dominant. Test accuracy
may change as new SARS-
CoV-2 viruses emerge.
Additional testing with a lab-
based molecular test (e.g.,
PCR) should be considered in
situations where a new virus or
variant is suspected. | This test is not a substitute for visits
to a healthcare provider or
appropriate follow-up and should not
be used to determine any treatments
without provider supervision.
Individuals who test negative and
experience continued or worsening
COVID-19 like symptoms, such as
fever, cough and/or shortness of
breath, should seek follow up care
from their healthcare provider.
The performance characteristics for
SARS-CoV-2 were established from
April 2023 to February 2024 when
SARS-CoV-2 Omicron was
dominant. Test accuracy may change
as new SARS-CoV-2 viruses
emerge. Additional testing with a lab-
based molecular test (e.g., PCR)
should be considered in situations
where a new virus or variant is
suspected. |
| Test
Principle | Lateral flow immunoassay | Lateral flow immunoassay |
| Sample type | Anterior nasal swab specimens | Anterior nasal swab specimens |
| Assay
targets | SARS-CoV-2 nucleocapsid
protein antigens | SARS-CoV-2 nucleocapsid protein
antigens |
| Assay Type | Qualitative | Qualitative |
| Read Results | Visual | Visual |
| Intended users and use location | OTC,
Patients or its guardians,
At home or similar place | OTC,
Patients or its guardians,
At home or similar place |
| Storage Temperature | 2°C to 30°C | 2°C to 30°C |
| Assay Control | Internal procedural control | Internal procedural control |
| Differences | | |
| Time to Result | 15 minutes to 30 minutes | 10 minutes to 20 minutes |

Table 1: Comparison to Predicate Device

7

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

8

510(k) Summary

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

Operation Principle ব

The Wondfo 2019-nCoV Antigen Test is a sandwich immunochromatographic assay that uses antibodies to detect SARS-CoV-2 nucleocapsid antigen extracted from nasal swab specimen.

A nasal swab sample is collected by the lay user and then inserted into the extraction buffer during which the extraction buffer disrupts the virus particles in the specimen to expose internal viral nucleocapsid antigens. The extracted specimen is added into the sample well of the test cassette. When an adequate volume of the specimen is added the sample well (S) of the test cassette, the specimen migrated by capillary action from the sample well over the conjugated pad and across the nitrocellulose membrane test strip. During the migration the reagents in the conjugated pad are solubilized. If SARS-CoV-2 nucleocapsid antigens are present in the sample, the antigens bind to the specific annti-SARS-CoV-2 antibody conjugated with dye particles on the conjugated pad and the antigen-antibody complexes captured by the anti-SARS-CoV-2 antibody immobilized at the test line region (T) to form sandwich complexes to generate a visible colored test line. Unbound conjugates continue to migrate across the nitrocellulose membrane and are captured at the control line region (C) to result in a visible colored control line that indicates adequate operations and sample flow during the test. If no SARS-CoV-2 nucleocapsid antigens are present in the sample, the conjugate will only be captured at the control line of the test.

Results are interpreted between 10 and 20 minutes after adding the extracted sample into the sample well. A false negative or false positive result may occur if the test result before 10 minutes or after 20 minutes.

9

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

Non-clinical Performance 5

5.1 Lot-to-Lot Precision

Precision was assessed by measuring repeatability using three levels of samples including negative samples, weak positive sample and a positive samples were prepared in negative clinical nasal swab matrix (NCM), blinded and randomized. 50uL were pipetted onto each swab and swabs were processed per the IFU. The following results were obtained from three kit lots testing each sample in duplicate per run by three operators and two runs per day over 20 days (3 lots × 3 operators × 2 replicates/sample × 2 runs/day/operator × 20 days). A total of 720 tests were run per panel member.

In addition, a supplemental precision study was conducted testing negative samples and a sample below the LoD (0.9 x LoD) to demonstrate potential lot variability. These samples were tested with three lots by two operators for two replicates per run and two run per day over three days (3 lots × 2 operators × 2 replicates/sample × 2 runs/day/operator × 3 days).

Sample Level	% Agreement with Expected Result
	Lot 1	Lot2	Lot 3	Total
Negative	240/240	240/240	240/240	720/720
	(100%)	(100%)	(100%)	(100%)
Weak positive
(1.5 x LoD)	240/240	240/240	240/240	720/720
	(100%)	(100%)	(100%)	(100%)
Positive
(3 x LoD)	240/240	240/240	240/240	720/720
	(100%)	(100%)	(100%)	(100%)
Negative	24/24	24/24	24/24	72/72
	(100%)	(100%)	(100%)	(100%)
0.9x LoD SARS-
CoV-2	20/24	20/24	24/24	64/72
	(83.33%)	(83.33%)	(100%)	(88.89%)

5.2 Analytical Sensitivity: Limit of Detection

The Limit of Detection (LoD) of the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was determined by evaluating different dilutions of two (2) variants of inactivated SARS-CoV-2 in pooled negative nasal swab matrix. A 10-fold dilution series was made to determine the preliminary LoD, which was measured using three (3) device lots in triplicate measurements (n=3/lot). 50uL were pipetted onto each swab and swabs were processed per the IFU. The LoD was confirmed using 20 replicates for each of the same three (3) lots. The lowest viral concentration that was detected greater than or equal to 95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive) was determined to be the LoD for that strain. The LoD was the same for all three lots tested.

Variant	Virus Strain	LoD

Original	USA-WA1/2020	$1.0\times10^4$	500

10

Guangzhou Wondfo Biotech Co., Ltd.			510(k) Summary
Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)
Omicron BA.5	USA/COR-22-063113/2022	$3.33\times10^3$	166.7

WHO Standard Testing

The Limit of Detection (LoD) of the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was determined by using different dilutions of 1st WHO International Standard for SARS-CoV-2 antigen (NIBS code: 21/368) in pooled negative nasal swab matrix. 50uL were pipetted onto each swab and swabs were processed per the IFU. The LoD was determined for three different reagent lots as the lowest virus concentration that was detected ≥ 95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive). The LoD was the same for all three lots tested.

WHO Standard		LoD
		IU/mL	IU/swab
SARS-CoV-2 antigen	NIBSC code: 21/368	$2.00x10^2$	10

5.3 Inclusivity (Analytical Reactivity)

Analytical reactivity for Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was demonstrated using six (6) additional strains of SARS CoV-2 virus and one (1) SARS-CoV-2 JN.1 clinical specimen, in an LoD-like study. For six (6) additional strains of SARS CoV-2 virus, a 10-fold dilution series was made to determine the preliminary analytical reactivity concentration, which was measured using three (3) device lots and in triplicate measurements (n=3). The preliminary analytical reactivity concentration was confirmed using 20 replicates in triplicate using the same three (3) lots. 50uL were pipetted onto each swab and swabs were processed per the IFU. The lowest viral concentration that was detected greater than or equal to 95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive) was determined to be the analytical reactivity concentration for that strain. For JN.1 variant testing, one (1) clinical specimen was serially diluted and tested with 5 replicates per dilution/concentration. The lowest concentration that detected 5 positive out of 5 samples represents analytical reactivity concentration for JN.1. The analytical reactivity of the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) with the variants is shown in table below:

| Variant | Virus Strain | Lowest Reactivity
Concentration |
|-------------------|-------------------------------------|------------------------------------|
| Alpha | England/204820464/2020 | $1.0×10^3$ TCID50/mL |
| Beta | South_Africa/KRISP-
K005325/2020 | $1.0×10^3$ TCID50/mL |
| Gamma | Japan/TY7-503/2021 | $1.0×10^3$ TCID50/mL |
| Delta | USA/PHC658/2021 | $1.0×10^2$ TCID50/mL |
| Omicron B.1.1.529 | USA/MD-HP20874/2021 | $1.0×10^2$ TCID50/mL |
| Omicron BA.2.3 | USA/MD-HP24556/2022 | $3.33×10^2$ TCID50/mL |
| JN.1 | Clinical specimen | Ct=27.9 ( $2.28×10^4$ GE/mL) |

11

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

5.4 Analytical Specificity

Microorqanism Cross-Reactivity and Microbial Interferences

To demonstrate that the device does not react with related viruses, other infectious pathogens, and normal flora that are reasonably likely to be encountered in nasal swab specimens cross-Reactivity and Microbial Interference of the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was evaluated by testing 30 microorganisms diluted into negative clinical nasal swab matrix and a sample of pooled nasal wash. Each microorganism was tested in three (3) replicates in the absence and presence of SARS-CoV-2 (USA/COR-22-063113/2022) at 2xLoD. None of the organisms and viruses evaluated demonstrated cross-reactivity or microbial interference in this assay at the concentrations tested.

| Microorganism (no analyte)
(# pos reps/total
reps) | Interference
(2xLoD SARS-CoV-2)
(# pos reps/total reps) |
|-------------------------- | Human coronavirus 229E | Human coronavirus OC43 | Human coronavirus NL63 | MERS-coronavirus | Coronavirus HKU 1 (n=2)* | SARS-CoV Nucleocapsid Protein
(His Tag)# | 0.25 ng/mL | Human Adenovirus 1 | Human Metapneumovirus (hMPV-
5) Type B1 | 2 x 105 TCID50/mL | Parainfluenza virus Type 1 | Parainfluenza virus Type 2 | Parainfluenza virus Type 3 | Parainfluenza virus Type 4A | Enterovirus | Respiratory syncytial virus | Rhinovirus | Influenza A/Victoria/4897/22 | Influenza A/Darwin/6/21 | Influenza B/Washington/02/19 | Influenza B/Florida/04/06 | Haemophilus influenzae type b | Bordetella pertussis | Candida albicans | Chlamydia pneumoniae | Legionella pneumophila | Mycoplasma tuberculosis | Mycoplasma pneumoniae | Staphylococcus aureus MRSA | Staphylococcus epidermidis | Final Concentration | Cross-Reactivity
-------------------|---------------------|----------------------------------------------------------------|---------------------------------------------------------------|
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| Ct = 20.5 - 22 | 0/6 | 6/6 |
| 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 5.62 x 104TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 2 x 105 TCID50/mL | 0/3 | 3/3 |
| 1.17 x 105TCID50/mL | 0/3 | 3/3 |
| 2 x 106 CFU/mL | 0/3 | 3/3 |
| 2 x 106 CFU/mL | 0/3 | 3/3 |
| 2 x 106 CFU/mL | 0/3 | 3/3 |
| 2 x 106 IFU/mL | 0/3 | 3/3 |
| 2 x 106 CFU/mL | 0/3 | 3/3 |
| 2 x 106 CFU/mL | 0/3 | 3/3 |
| 2 x 106 CCU/mL | 0/3 | 3/3 |
| 2 x 106 CCU/mL | 0/3 | 3/3 |
| 2 x 106 CFU/mL | 0/3 | 3/3 |

12

510(k) Summary

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

Streptococcus pneumoniae	2 x 106 CFU/mL	0/3	3/3
Streptococcus pyogenes	2 x 106 CFU/mL	0/3	3/3
Pneumocystis jirovecii (PJP) - S.
cerevisiae#	2x106 CFU/mL	0/3	3/3
Pooled human nasal wash	NA	0/3	3/3

| #Recombinant protein/strains were tested as the live or inactivated strains were hard to obtain

Interfering Substances

Forty-two (42) potentially interfering substances, diluted in negative nasal swab matrix, were tested with the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method). Each substance was tested in three (3) replicates in the absence and presence of heatinactivated SARS-CoV-2 (isolate USA/COR-22-063113/2022) at 2xLoD. The endogenous and exogenous interfering substances do not cross-react or interfere with the performance of the device at the concentrations tested.

| Interfering Substances | Concentration | Cross-Reactivity
(no analyte)
(# pos reps/total reps) | Interference
(2xLoD SARS-CoV-2)
(# pos reps/total reps) |
|---------------------------------------------------|---------------|-------------------------------------------------------------|---------------------------------------------------------------|
| Whole Blood | 2.5% | 0/3 | 3/3 |
| Mucin | 2.5mg/mL | 0/3 | 3/3 |
| Chloraseptic sore throat lozenges
(Benzocaine) | 3mg/mL | 0/3 | 3/3 |
| Chloraseptic sore throat lozenges
(Menthol) | 3mg/mL | 0/3 | 3/3 |
| NeilMed (Sodium chloride with
preservatives) | 15% v/v | 0/3 | 3/3 |
| CVS Nasal Drops (Phenylephrine) | 15% v/v | 0/3 | 3/3 |
| Afrin (Oxymetazoline) | 15% v/v | 0/3 | 3/3 |
| CVS Nasal Spray (Cromolyn) | 15% v/v | 0/3 | 3/3 |
| Zicam | 15% v/v | 0/3 | 3/3 |
| Homeopathic (Alkalol) | 15% v/v | 0/3 | 3/3 |
| Sore Throat Phenol Spray | 5% w/v | 0/3 | 3/3 |
| Tobramycin | 4 µg/mL | 0/3 | 3/3 |
| Mupirocin | 10 mg/mL | 0/3 | 3/3 |
| Fluticasone Propionate | 15% v/v | 0/3 | 3/3 |
| Tamiflu (Oseltamivir Phosphate) | 5mg/mL | 0/3 | 3/3 |
| Biotin | 3.5 µg/mL | 0/3 | 3/3 |
| Menthol | 0.015% w/v | 0/3 | 3/3 |
| Bleach | 0.01% v/v | 0/3 | 3/3 |
| Dish Soap | 1% v/v | 0/3 | 3/3 |
| Laundry Detergent | 1% v/v | 0/3 | 3/3 |
| Multisurface Cleaner | 1% v/v | 0/3 | 3/3 |
| Hand Soap | 1% v/v | 0/3 | 3/3 |

13

510(k) Summary

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

| Interfering Substances | Concentration | Cross-Reactivity
(no analyte)
(# pos reps/total reps) | Interference
(2xLoD SARS-CoV-2)
(# pos reps/total reps) |
|---------------------------|----------------------|-------------------------------------------------------------|---------------------------------------------------------------|
| Laundry Detergent | 1% w/v | 0/3 | 3/3 |
| Bar Soap | 1% w/v | 0/3 | 3/3 |
| Multipurpose Cleaner | 1% v/v | 0/3 | 3/3 |
| Hand Sanitizer | 1% v/v | 0/3 | 3/3 |
| Aspirin | 15 mg/mL | 0/3 | 3/3 |
| Motrin (Ibuprofen) | 50 mg/mL | 0/3 | 3/3 |
| Naproxen | 20 mg/mL | 0/3 | 3/3 |
| Budesonide | 15% v/v | 0/3 | 3/3 |
| Flunisolide | 15% v/v | 0/3 | 3/3 |
| Triamcinolone | 15% v/v | 0/3 | 3/3 |
| Dexamethasone | 5 mg/mL | 0/3 | 3/3 |
| Beclomethasone | 15% v/v | 0/3 | 3/3 |
| Remdesivir | 5 mg/mL | 0/3 | 3/3 |
| Molnupiravir | 5 mg/mL | 0/3 | 3/3 |
| Leukocytes | ≥1 x10^6
cells/mL | 0/3 | 3/3 |
| Zinc | 15% v/v | 0/3 | 3/3 |
| Luffa opperculata | 1.25% | 0/3 | 3/3 |
| Galphimia glauca | 15% v/v | 0/3 | 3/3 |
| Histaminum hydrochloricum | 15% v/v | 0/3 | 3/3 |
| Zanamivir | 10mg/mL | 0/3 | 3/3 |

5.5 High Dose Hook Effect

No high-dose hook effect was observed when Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) was used to test specimens containing SARS-CoV-2 Omicron Lineage BA.5 (hCoV19/USA/COR-22-063113/2022) viral concentration as high as 1.98 x 10º TCID50/mL.

5.6 Usability and User Comprehension Studies

Usability Study

A usability study was conducted to assess the lay user's ability to understand the instructions for use and to adequately execute the device accordingly. A total of 30 participants, aged 14 years and older and caregiver-child (ages 2-13 years) pairs and caregiver-adult pairs, were enrolled in the study and were observed during testing. A total of 30 participants completed testing monitored by investigators. Following the usability study, all subjects were assessed for their understanding and were issued a questionnaire to assess users' comprehension of the test. The questionnaire was completed by 30 subjects. The questionnaire assessed users' understanding of concepts such as the test

14

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

purpose and interpretation of results. The results of each study were deemed acceptable and demonstrated that the instructions for use were easy to follow.

Readability Study

The purpose of this study was to evaluate whether lay users (patients or their caregivers) can interpret test results correctly with low positive samples from the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method). The Readability Study was conducted in a simulated home environment. A total of 50 lay users with diverse gender, ages and educational background who met the study inclusion criteria, were enrolled for the Readability Study. Each lay user was asked to interpret two panels of 5 test devices with three different concentrations that were arranged in blinded test panels with the following sample results; the order of the results within the panel was randomized:

Panel 1: Negative, 1.5xLoD, 1.5xLoD, 5xLoD, Invalid
Panel 2: Negative, Negative, 1.5xLoD, 5xLoD, Invalid

42% (21/50) of the study participants were male and 58% (29/50) of the study participants were female. 64% (32/50) of individuals were vision impaired, and 18% (9/50) of individuals were either still at high school or had a high school degree as their highest level of education. Readability outcomes are shown in the table below.

| Sample Level | Number of Test
Results Across all
Participants | Number of Correct
Interpretation | Observed
Performance (%) |
|--------------|------------------------------------------------------|-------------------------------------|-----------------------------|
| Negative | 150 | 146 | 97.33% |
| 1.5xLoD | 150 | 140 | 93.33% |
| 5xLoD | 100 | 100 | 100% |
| Invalid | 100 | 100 | 100% |

Clinical studies 6

A prospective study was performed in which one thousand and fifty-three (1053) direct anterior nasal swab specimens were sequentially enrolled (between April 2023 and February 2024) and tested fresh with the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method). The samples were collected from symptomatic patients suspected of infection with respiratory symptoms, at nine (9) clinical sites. Subjects performed testing on selfcollected swab samples in age groups 14 and older, and adult collected samples for age groups 2-13, in a simulated at-home environment. To be enrolled in the study, patients had to present at the participating study site with signs and symptoms of respiratory infection generally observed from SARS-CoV-2 during the study period. Two anterior nasal swab specimens were collected from each patient: one swab was collected by a healthcare professional and sent for testing using an FDA-cleared highly sensitive molecular comparator method, and the other swab was self-collected and tested immediately with the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) per the test procedure. Out of 1053 enrolled subjects, there were 1032 evaluable subjects within 5 days of symptom onset (DPSO).

15

Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)

Subjects Demographics

Characteristic	# Evaluable Subjects	% of Total
2-13 years of age	117	11.34%
14-21 years of age	86	8.33%
22-64 years of age	698	67.64%
> 65 years of age	131	12.69%
Total	1032	100%
Male	414	40.12%
Female	618	59.88%
Total	1032	100%
Self-collected sample	900	87.21%
Sample collected by other	132	12.79%
Total	1032	100%

Performance of the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) in Symptomatic subjects

		FDA-Cleared Comparator Method
		Positive	Negative	Total
The
proposed
device	Positive	108	3	111
	Negative	20	901	921
	Total	128	904	1032
Positive Percent Agreement (PPA)		84.38% (108/128) (95% CI:77.10% - 89.65%)
Negative Percent Agreement (NPA)		99.67% (901/904) (95% CI:99.03% - 99.89%)

Clinical Performance in Subjects on Days Post Symptoms Onset

Days Since Symptom Onset	PPA	NPA
0	100.00% (5/5)	100.00% (19/19)
1	90.91% (20/22)	100.00% (153/153)
2	82.35% (28/34)	99.69% (318/319)
3	83.33% (25/30)	99.13% (228/230)
4	86.36% (19/22)	100.00% (116/116)
5	73.33% (11/15)	100.00% (67/67)
Total	84.38% (108/128)	99.67% (901/904)

7 Conclusion

The information provided in this Premarket Notification [510(k)] demonstrates that the performance of the Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) is substantially equivalent in intended use, technological characteristics, and performance to the predicate device.