The iHealth Flu A&B/COVID-19 Rapid Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar.

This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

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

iHealth Flu A&B/COVID-19 Rapid Test Pro:

The iHealth Flu A&B/COVID-19 Rapid Test Pro is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid protein directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar.

This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

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.

Test results should not be used as the sole basis for treatment or other patient management decisions.

Device Description

The iHealth Flu A&B/COVID-19 Rapid Test and iHealth Flu A&B/COVID-19 Rapid Test Pro is a lateral flow immunoassay device intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.

This over the counter (OTC) test has two versions, one labeled for self-testing use, the (iHealth Flu A&B/COVID-19 Rapid Test), and one labeled for professional use (iHealth Flu A&B/COVID-19 Rapid Test Pro) (generically referred to as iHealth Flu A&B/COVID-19 Rapid Test for the remainder of this document). Both versions of the iHealth Flu A&B/COVID-19 Rapid Test have an identical general design and are intended to separately detect antigen from influenza A, influenza B, and SARS-CoV-2 in anterior nares swabs from individuals with signs and symptoms of respiratory infection within the first five (5) days of symptom onset. The iHealth Flu A&B/COVID-19 Rapid Test is validated for testing direct anterior nares samples (ANS) without transport media. The iHealth Flu A&B/COVID-19 Rapid Test does not use biotin-streptavidin/avidin chemistry.

The test card in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with four lines: three test lines (Flu A line, Flu B line and SARS CoV-2 line) and a control line (Ctrl line).

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - iHealth Flu A&B/COVID-19 Rapid Test

Page 1

December 12, 2025

iHealth Labs, Inc
Yange Wang
Associate Manager, QMS & RA
880 W Maude Ave
Sunnyvale, California 94085

Re: K251092
Trade/Device Name: iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
Regulation Number: 21 CFR 866.3987
Regulation Name: Multi-Analyte Respiratory Virus Antigen Detection Test
Regulatory Class: Class II
Product Code: SCA
Dated: April 9, 2025
Received: April 10, 2025

Dear Yange Wang:

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"

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(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 (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-safety-reporting-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-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).

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Sincerely,

JOSEPH BRIGGS -S

Joseph W. Briggs, Ph.D.
Deputy Director
Division of Microbiology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23) Page 1 of 2

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.

510(k) Number (if known): K251092

Device Name: iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro

Indications for Use (Describe)

iHealth Flu A&B/COVID-19 Rapid Test:

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.

Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

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

iHealth Flu A&B/COVID-19 Rapid Test Pro:

This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

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.

Test results should not be used as the sole basis for treatment or other patient management decisions.

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

☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/23) Page 2 of 2

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."

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iHealth Flu A&B/COVID-19 FDA 510(k) Files

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1.0 Submitter's information

Name: iHealth Labs, Inc.
Address: 880W Maude Ave Sunnyvale, CA 94085 USA
Phone number: 1-408-663-8349
Contact: Yange Wang
Contact email: policy@ihealthlabs.com
Date: December 11, 2025

2.0 Device information and Classification

Device name: iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro
Classification name: Multi analyte respiratory virus antigen detection test
Regulation number: 21 CFR 866.3987
Product code: SCA
Classification: Class II
Review Panel: Microbiology

3.0 Predicate device information

510(k) number	K243256
Manufacturer	Wondfo USA Co., Ltd.
Trade/Proprietary Name	WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B Antigen Test
Classification Regulation	21 CFR 866.3987 - Multi analyte respiratory virus antigen detection test
Classification	Class II
Product Code	SCA

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4.0 Device description

5.0 Indications for use

iHealth Flu A&B/COVID-19 Rapid Test

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.

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.

Page 8

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

iHealth Flu A&B/COVID-19 Rapid Test Pro

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.

Test results should not be used as the sole basis for treatment or other patient management decisions.

6.0 Intended use

Same as Indications for Use above.

7.0 Technological Comparison

Characteristics	Subject device (K251092)	Predicate device (K243256)	Comparison
Device Trade Name	iHealth Flu A&B/COVID-19 Rapid Test and iHealth Flu A&B/COVID-19 Rapid Test Pro	WELLlife COVID-19 / Influenza A&B Home Test and WELLlife COVID-19 / Influenza A&B AntigenTest	--
Assay Target	SARS-CoV-2 nucleocapsid protein antigensInfluenza A nucleoprotein antigensInfluenza B nucleoprotein antigens	SARS-CoV-2 nucleocapsid protein antigensInfluenza A nucleoprotein antigensInfluenza B nucleoprotein antigens	Same
Indications For	iHealth Flu A&B/COVID-19 Rapid Test	WELLlife COVID-19 / Influenza A&B Home Test	Similar

Page 9

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

Page 10

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iHealth Flu A&B/COVID-19 Rapid Test Pro

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.

Test results should not be used as the sole basis for treatment or other patient management decisions.

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

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 providers.

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

Test results should not be used as the sole basis for treatment or other patient management decisions.

Test Principle	Lateral flow immunoassay	Lateral flow immunoassay	Same
Specimen Type	Anterior nasal	Anterior nasal	Same
Assay Result	Qualitative	Qualitative	Same
Detection Format	Visually read	Visually read	Same
Assay Control	Internal procedural control	Internal procedural control	Same
Intended Use Population	Individuals with signs and symptoms of respiratory tract infection	Individuals with signs and symptoms of respiratory tract infection	Same
Presentation or OTC	OTC	OTC	Same
Usage	Single use test	Single use test	Same
Time to Result	15-30 min	15-20 min	Different*
Storage Condition	2-30 °C	2-30 °C	Same

8.0 Operation Principle

The iHealth Flu A&B/COVID-19 Rapid Test employs lateral flow immunoassay technology. Using this test allows for the rapid detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.

To begin the test, a self-collected anterior nasal swab sample (in individuals aged 14 years and older or individuals between the ages of 2 to 13 with a swab collected by an adult) is inserted into the reagent buffer tube. The liquid in the reagent buffer tube interacts with the specimen and facilitates exposure of the appropriate viral antigens to the antibodies used in the test. The liquid in the reagent buffer tube now containing the specimen is added to the sample well of the Test Card. The solution of extracted specimen flows onto the test strip and migrates through the pads and membrane of the test strip. The pads contain detection antibodies and control antigen conjugated to latex microspheres and the membrane contains immobilized capture antibodies and control antibody.

If Influenza A, Influenza B, SARS-CoV-2 antigens are present in the specimen, they will react with either anti-influenza antibodies labeled with latex microspheres or anti-SARS-CoV-2 antibodies, migrate through the membrane as antigen-antibody-latex microspheres

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complexes, bind to the immobilized capture antibody line(s) on the membrane, and generate a colored line in the specific test line position.

The rest of the sample and unbound/bound latex microspheres complexes continue to migrate to the Control line position (Ctrl), where immobilized control antibodies capture the control antigen-latex microspheres complexes and form the Control line. Formation of the Control line serves as an internal control to demonstrate that test reagents are functional, the antibody-latex microspheres conjugates in the latex microspheres pad have been hydrated and released and that sufficient sample has been applied to allow for migration through the Test and Control lines. If the Control line does not appear within the designated incubation time, the result is invalid and the test should be repeated using a new test device and specimen.

9.0 Non-clinical Performance summary

9.1 Precision Study

A lot-to-lot precision study was conducted at a single site to evaluate variability between-lots, between-operator, between-run and between-days.

The following panel was tested: a negative sample (PNF only), a low positive sample (0.8x LoD of SARS-CoV-2, Flu A, Flu B, 0.8x co-spiked Flu A &Flu B, SARS-CoV-2 &Flu B, Flu A &Flu B & SARS-CoV-2), moderate positive samples (3x LoD of positive samples same as above). The strains used for testing were chemically inactivated SARS-CoV-2 Lineage JN.1, live influenza A/H1N1, and live influenza B Victoria.

Two replicates per sample panel was tested per run, per operator, and per lot across 10 days with two test runs per day for a total of 240 results per sample panel (3 lots x 2 operators x 2 replicate x 10 days x 2 runs per day).

Precision was determined by comparing test results to expected results across all lots operators, and days. Results are shown in the table below. All replicates prepared at 3xLoD demonstrated 100% agreement across the operators, lots, days and runs tested. The expected lot to lot imprecision was observed with the 0.8X LoD samples. There were no invalid test results in the above study.

Table 1. Precision study Results

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Analyte	Test line	No. of Positives / No. of Samples tested (%)	Total no. of positives / Total no. of samples (%)
		Lot 1	Lot 2
Negative	SARS-CoV2	0/80 (0%)	0/80 (0%)
	Flu A	0/80 (0%)	0/80 (0%)
	Flu B	0/80 (0%)	0/80 (0%)
0.8X LoD SARS-CoV-2	SARS-CoV2	25/80 (31.3%)	18/80 (22.5%)
	Flu A	0/80 (0%)	0/80 (0%)
	Flu B	0/80 (0%)	0/80 (0%)
0.8X LoD Flu A	SARS-CoV2	0/80 (0%)	0/80 (0%)
	Flu A	49/80 (61.3%)	49/80 (61.3%)
	Flu B	0/80 (0%)	0/80 (0%)
0.8X LoD Flu B	SARS-CoV2	0/80 (0%)	0/80 (0%)
	Flu A	0/80 (0%)	0/80 (0%)
	Flu B	28/80 (35.0%)	39/80 (48.8%)
0.8X LoD Flu A/Flu B	SARS-CoV2	0/80 (0%)	0/80 (0%)
	Flu A	28/80(35.0%)	39/80(48.8%)
	Flu B	40/80 (50.0%)	42/80 (52.5%)
0.8X LoD SARS-CoV2/Flu A/Flu B	SARS-CoV2	39/80 (48.8%)	29/80 (36.3%)
	Flu A	47/80 (58.8%)	47/80 (58.8%)
	Flu B	43/80 (53.8%)	45/80 (56.3%)
3X LoD SARS-CoV-2**	SARS-CoV2	80/80 (100%)	80/80 (100%)
	Flu A	0/80 (0%)	0/80 (0%)
	Flu B	0/80 (0%)	0/80 (0%)

*The 3X LoD samples were evaluated using the same combination of sample types and test conditions as those used for the 0.8X LoD testing, and all results were concordant, demonstrating 100% agreement

9.2 Analytical Specificity/Interference:

a) Cross Reactivity (Analytical Specificity) and Microbial Interference

A Cross-reactivity study was conducted by testing a panel of microorganisms commonly found as either pathogens or normal flora in respiratory samples individually spiked into Pooled Negative Nasal Fluid (PNF). Each organism was tested in replicates of three (3) without SARS-CoV-2, Influenza A, or Influenza B present in the sample.

The microbial interference study was conducted in the same manner, but samples were prepared in the presence of chemical inactivated SARS-CoV-2, live influenza A and B co-

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spiked into the samples at 3x LoD. The testing was performed in triplicate for each microorganism.

Results are summarized in Table 2. Neither cross-reactivity nor microbial interference was observed for any of the tested microorganisms at the concentration used in the study.

Table 2. Cross reactivity and microbial interference results

Microorganism	Working Concentration	Cross-reactivity Results (# pos / total)	Interference Results (# pos / total)
SARS-CoV-1*	1.25×10⁵ PFU/ml	0/3	3/3
MERS-coronavirus	1.58×10⁸ GE/mL	0/3	3/3
Human coronavirus HKU1 (HKU1/UNC/2/2022)	4.34×10⁶ GE/mL	0/3	3/3
Human coronavirus OC43	7.00×10⁵ TCID₅₀/mL	0/3	3/3
Human coronavirus 229E	1.40×10⁵ TCID₅₀/mL	0/3	3/3
Human coronavirus NL63	8.00×10⁴ TCID₅₀/mL	0/3	3/3
Adenovirus,Type 1	2.23×10⁵ TCID₅₀/mL	0/3	3/3
Adenovirus Type 7A	1.58×10⁵ TCID₅₀/mL	0/3	3/3
Cytomegalovirus	1.00×10⁵ PFU/mL	0/3	3/3
Epstein Barr Virus, Strain	1.83×10⁶ CP/mL	0/3	3/3
Human Metapneumovirus (hMPV)	3.50×10⁵ TCID₅₀/mL	0/3	3/3
Parainfluenza virus 1	2.00×10⁵ TCID₅₀/mL	0/3	3/3
Parainfluenza virus 2	1.75×10⁵ TCID₅₀/mL	0/3	3/3
Parainfluenza virus 3	7.00×10⁵ TCID₅₀/mL	0/3	3/3
Parainfluenza virus 4	2.39×10⁵ TCID₅₀/mL	0/3	3/3
Enterovirus Type 68	2.23×10⁵ TCID₅₀/mL	0/3	3/3
Respiratory syncytial virus A	1.49×10⁵ TCID₅₀/mL	0/3	3/3
Respiratory syncytial virus B	1.58×10⁵ TCID₅₀/mL	0/3	3/3
Rhinovirus	2.23×10⁶ TCID₅₀/mL	0/3	3/3
Bordetella pertussis	2.50×10⁸ CFU/mL	0/3	3/3
Candida albicans	6.03×10⁶ CFU/mL	0/3	3/3
Chlamydia pneumoniae	4.33×10⁶ IFU/mL	0/3	3/3

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Microorganism	Working Concentration	Cross-reactivity Results (# pos / total)	Interference Results (# pos / total)
Corynebacterium xerosis	2.30×10⁷ CFU/mL	0/3	3/3
Escherichia coli	1.18×10⁸ CFU/mL	0/3	3/3
Hemophilus influenzae	3.00×10¹⁰ CFU/mL	0/3	3/3
Lactobacillus sp	8.50×10⁶ CFU/mL	0/3	3/3
Legionella pneumophila	6.50×10⁶ CFU/mL	0/3	3/3
Moraxella catarrhalis	2.50×10⁸ CFU/mL	0/3	3/3
Mycoplasma pneumoniae	2.50×10⁷ CFU/mL	0/3	3/3
Mycobacterium tuberculosis	4.15×10⁶ CFU/mL	0/3	3/3
Neisseria meningitidis	3.43×10⁶ CFU/mL	0/3	3/3
Neisseria Elongata	2.68×10⁸ CFU/mL	0/3	3/3
Pneumocystis jirovecii	1.30×10⁷ CFU/mL	0/3	3/3
Pseudomonas aeruginosa	1.23×10⁸ CFU/mL	0/3	3/3
Staphylococcus aureus	2.60×10⁸ CFU/mL	0/3	3/3
Staphylococcus epidermidis	9.00×10⁷ CFU/mL	0/3	3/3
Streptococcus salivarius	1.01×10⁶ CFU/mL	0/3	3/3
Streptococcus pneumoniae	3.88×10⁷ CFU/mL	0/3	3/3
Streptococcus pyogenes	7.50×10⁷ CFU/mL	0/3	3/3
Measles	2.23×10⁵ TCID₅₀/mL	0/3	3/3
Mumps	8.48×10⁵ TCID₅₀/mL	0/3	3/3
PNF(Pooled Negative Nasal Fluid)	NA	0/3	3/3

strains were gamma-irradiated prior to wet-testing.

b) Exogenous and Endogenous Interference Study

The iHealth Flu A&B/COVID-19 Rapid Test was evaluated for performance in the presence of potentially interfering substances that might be present in respiratory specimens.

Negative PNF samples were evaluated in the presence of the interfering substances in triplicate to confirm these substances do not interfere with the detection of the target analytes.

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Contrived positive samples containing 3x co-spiked analytes for SARS-CoV-2, Influenza A H1N1, and Influenza B Victoria in PNF (same as the strains tested in the co-spiked LoD study) were evaluated in the presence of the interfering substances in triplicate to confirm these substances do not interfere with the detection of the target analytes.

Testing was performed with a panel of endogenous and exogenous substances diluted in PNF to the recommended concentration. Results are summarized in Table 3.

Table 3. Endogenous/exogenous interfering substances study results

Substance	Concentration	Cross-reactivity (no analyte) (# pos reps / total reps)	Interference (3x LoD co-spiked analytes) (# pos reps / total reps)
		SARS-CoV-2	Flu A
Human Whole Blood (EDTA tube)	4% v/v	0/3	0/3
Leukocytes	1.67×10⁶ cells/mL	0/3	0/3
Mucin	5mg/mL	0/3	0/3
Chloraseptic (Menthol/Benzocaine)	1.5 mg/mL	0/3	0/3
	3 mg/mL	0/3	0/3
Zinc (TheraZinc Throat Spray)	15% v/v	0/3	0/3
Naso GEL (NeilMed)	15% v/v	0/3	0/3
Nasal gel (Galphimia glauca, Histanium hydrocloricum, Luffa operculata, Sulfur)	1.25% v/v	0/3	0/3
Nasal Drops (Phenylephrine)	15% v/v	0/3	0/3
Nasal Spray (Oxymetazoline)	15% v/v	0/3	0/3
Nasal Spray (Cromolyn)	15% v/v	0/3	0/3
Nasal spray (Saline)	15% v/v	0/3	0/3
Homeopathic Nasal Spray (Alkalol)	15% v/v	0/3	0/3
Zicam	5% v/v	0/3	0/3
	15% v/v	0/3	0/3
Homeopathic allergy relief (Histaminum hydrochloricum)	15% v/v	0/3	0/3

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Substance	Concentration	Cross-reactivity (no analyte) (# pos reps / total reps)	Interference (3x LoD co-spiked analytes) (# pos reps / total reps)
		SARS-CoV-2	Flu A
Sore Throat Phenol Spray	15% v/v	0/3	0/3
Fluticasone Propionate	5% v/v	0/3	0/3
	15% v/v	0/3	0/3
Nasal corticosteroid (Dexamethasone)	1 mg/mL	0/3	0/3
Nasal corticosteroid (Triamcinolone)	15% v/v	0/3	0/3
Tamiflu (Oseltamivir Phosphate)	5 mg/mL	0/3	0/3
Tobramycin	4 μg/mL	0/3	0/3
Mupirocin	10 mg/mL	0/3	0/3
2024-25 FluMist® Influenza Vaccine Live intranasal*	15% v/v	0/3	3/3
	1.5% v/v	0/3	3/3
	0.75% v/v	0/3	3/3
	0.375% v/v	0/3	3/3
	0.1875% v/v	0/3	0/3
	0.15% v/v	0/3	0/3
Zanamivir	282 ng/mL	0/3	0/3
Anti-viral drug (Remdesivir)	10 mg/mL	0/3	0/3
Biotin	3,500 ng/mL	0/3	0/3
Body & Hand Lotion	0.5% w/v	0/3	0/3
Body Lotion, with 1.2% dimethicone	0.5% w/v	0/3	0/3
Hand Lotion	5% w/v	0/3	0/3
Hand Sanitizer with Aloe, 62% ethyl alcohol	5% v/v	0/3	0/3
Hand Sanitizer cream lotion	15% v/v	0/3	0/3
	7.5% v/v	NT	NT
	1.5% v/v	NT	NT
Hand Sanitizer, 80% ethanol, fast drying	15% v/v	0/3	0/3
	7.5% v/v	NT	NT
	3.75% v/v	NT	NT
	1.875% v/v	NT	NT
	1.5% v/v	NT	NT

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Substance	Concentration	Cross-reactivity (no analyte) (# pos reps / total reps)	Interference (3x LoD co-spiked analytes) (# pos reps / total reps)
		SARS-CoV-2	Flu A
Hand soap liquid gel	10% w/v	0/3	0/3
None (only PNF)	N/A	0/3	0/3
None (3x LoD Co-spike)	N/A	NT	NT

*NT: Not test.

c) Competitive Interference

Competitive interference of the test's analytes was tested with different combinations of low (3x LoD) and high concentrations of Flu A, Flu B and SARS-CoV-2 prepared in PNF. Inactivated SARS-CoV-2, live influenza A and 2 live influenza B virus strains were used in this study.

The table below summarizes the results of the competitive interference study. For each condition tested, all three replicates at the low target analyte condition tested positive in the presence of a second target analyte at high concentrations. No false positive results were observed.

Table 4. Competitive interference results

Sample	Competing virus	Target virus	Target analyte Percent Positivity
	Virus type	Concentration (TCID₅₀/mL)	Virus type
1	Influenza A/H1N1	6.73×10⁴	Influenza B/Victoria
2	Influenza A/H1N1	6.73×10⁴	SARS-CoV-2
3	Influenza A/H1N1	6.73×10⁴	Influenza B/Victoria
			SARS-CoV-2
4	Influenza B/Victoria	9.40×10⁵	Influenza A/H1N1
5	Influenza B/Victoria	9.40×10⁵	SARS-CoV-2
6	Influenza B/Victoria	9.40×10⁵	Influenza A/H1N1
			SARS-CoV-2

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| 7 | SARS-CoV-2 | 4.67×10⁴ | Influenza A/H1N1 | 1.20×10² | 100% |
| 8 | SARS-CoV-2 | 4.67×10⁴ | Influenza B/Victoria | 2.12×10³ | 100% |
| 9 | SARS-CoV-2 | 4.67×10⁴ | Influenza A/H1N1 | 1.20×10² | 100% |
| | | | Influenza B/Victoria | 2.12×10³ | |

10.3 Detection Limit

a) Limit of Detection (LOD)

LoD studies determined the lowest detectable concentration of SARS-CoV-2, influenza A and influenza B at which 95% of all (true positive) replicates tested positive. A preliminary LoD was determined independently for two strains of Flu A, two strains of Flu B, and one strain of SARS-CoV-2 by first testing a series of ten-fold dilutions of each virus spiked into Pooled Negative Nasal Fluid (PNF). Once the ten-fold breakpoint was established, an additional series of three (3) two-fold dilutions of the lowest positive ten-fold dilution concentration for each virus were independently tested at triplicates to determine a preliminary LoD.

Confirmatory LoD testing was performed by testing twenty (20) replicates at the preliminary (1X) LoD concentration determined above. The acceptance criteria for confirmation of the LoD was that 95% of the replicates (19/20) test positive.

LOD testing was conducted on three separate device lots, with each lot generating its own LoD. The final device LOD was determined by selecting the highest LoD from the three lots as the overall LOD for the device.

Table 5. Confirmatory LoD Determination

Virus Strains	LoD in PNF	LoD per Swab	#Positive/#total Tested	Percent Detected (%)

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b) Co-Spike LoD Equivalence

After the single analyte LoDs were established for the candidate device, co-spike equivalency testing was conducted to characterize performance on samples that contained all analytes at low concentrations.

Based on individual analyte LoD, a 1X Co-spike concentration was prepared by mixing viruses (one each of SARS-CoV-2, Flu A, Flu B with most challenging (i.e., lowest) LoD determined to have the lowest (best) LoD.

The 1X prepared sample concentration was tested on the candidate device using twenty (20) replicates. The results show ≥19/20 (≥100%) replicates are positive, which complies with the acceptance criteria. Additionally, all (3/3) negative replicates tested negative. Therefore, the LoD in co-spiked samples was deemed equivalent to the LoD in samples prepared with single analytes.

Table 6. Confirmatory co-spike analyte LoD results

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Virus Strain Co-Spiked in Sample	Final Concentration	Positive Replicates
SARS-CoV-2+Flu A-H1N1+Flu B-Victoria	6.30 ×10⁰ TCID₅₀/mL	3.15×10⁻¹ TCID₅₀/swab
	3.99 ×10¹ TCID₅₀/mL	2.00 ×10⁰ TCID₅₀/swab
	7.05 ×10² TCID₅₀/mL	3.53 ×10¹ TCID₅₀/swab
Negative	NA

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

The LoD of the candidate device was determined with the First WHO International Standard for SARS-CoV-2 antigen (NIBSC code: 21/368). The preliminary LoD concentration was determined by testing a series of 2-fold dilutions in PNF with one device lot, starting with a 5-fold dilution from the stock concentration (20,000 IU/mL) of the WHO International Standard for SARS-CoV-2 Antigen. Each dilution tested triplicate (n=3) replicates. Once the lowest positive 2-fold dilution concentration was established. And the preliminary LoD concentration was determined.

LoD confirmation testing was performed by testing twenty (20) replicates at the preliminary (1X) LoD concentration determined above. The results of the confirmation LoD testing are summarized in Table 7 with the confirmation LoD in bold.

Table 7. Confirmation LoD determination for WHO International Standard

Concentration (IU/mL) in PNF	Result (number of positive/total number)
	SARS-CoV-2
2.50 × 10²	20/20
2.25 × 10²	20/20
1.94 × 10²	19/20
1.88 × 10²	15/20
5.82 × 10²	20/20
6.47 × 10¹	0/20

1.94 × 10² IU/mL (9.7 IU/swab) was determined as the confirmatory LoD of the iHealth Flu A&B/COVID-19 Rapid Test using First WHO International Standard for SARS-CoV-2 antigen (NIBSC code: 21/368).

9.4 High-Dose Hook Effect Study:

The candidate device was tested to determine if it was affected by a high dose hook effect at high concentrations of the three analytes. A high dose of chemically inactivated SARS-

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CoV-2, and live influenza A and B were tested in this study. No high dose hook effect was observed for any panel analytes at the concentrations tested.

Table 8. High-dose hook effect study results

Strain	Hook Effect Concentration.	Positive Results / Total Replicates
		SARS-CoV-2
SARS-CoV-2	1.40 ×10⁵ TCID₅₀/mL	3/3
Flu A- H1N1	2.02 ×10⁵ TCID₅₀/mL	0/3
Flu A - H3N2	4.17 ×10⁵ TCID₅₀/mL	0/3
Flu B - Victoria	2.82 ×10⁶ TCID₅₀/mL	0/3
Flu B-Yamagata	1.10 ×10⁹ CEID₅₀/mL	0/3

9.5 Inclusivity Study:

Analytical reactivity was performed for the iHealth Flu A&B/COVID-19 Rapid Test on a selection of temporally, geographically, and genetically diverse influenza strains were tested for inclusivity. A series of ten-fold dilutions of each virus was spiked into PNF and tested. Once the ten-fold LoD range was established for each strain, an additional three two-fold dilution series of the lowest positive ten-fold dilution for each virus was tested in triplicate to demonstrate inclusivity. Based on this dilution series, the minimum detectable concentration was defined as the lowest concentration for which all three replicates were detected. Results are summarized in Table 9. Data demonstrate that the iHealth Flu A&B/COVID-19 Rapid Test is inclusive for the SARS-CoV-2 and influenza A and B analytes across a range of strains.

Table 9. Analytical reactivity with relevant variants

Virus	Strain	Concentration
Influenza A (H1N1)	A/Victoria/4897/22	5.05×10¹ TCID₅₀/mL
	A/Brisbane/02/2018	3.78×10¹ TCID₅₀/mL
	A/Macha/O1453/2021	2.80×10⁵ TCID₅₀/mL
	A/NY/03/2009	2.29×10⁴ TCID₅₀/mL
	A/Sydney/5/2021	1.20×10³ TCID₅₀/mL
	A/Baltimore/JH-22377/2022	8.00×10⁵ TCID₅₀/mL
	A/Wisconsin/67/2022	1.05×10² TCID₅₀/mL
	A/Hawaii/66/2019	1.85×10⁷ CEID₅₀/mL
	A/Wisconsin/588/2019	3.50×10³ FFU/mL
	A/Indiana/02/2020	2.43×10⁶ CEID₅₀/mL
	A/California/04/2009	7.00×10² TCID₅₀/mL
	A/Ohio/09/2015	3.50×10⁵ CEID₅₀/mL

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strains were gamma-irradiated prior to wet-testing

10.0 Clinical Testing Summary

a) Clinical Study Design

A prospective study was performed in which five hundred ninety-two (592) study subjects were sequentially enrolled (between November 2024 and March 2025). Anterior nasal swab (ANS) samples were collected from symptomatic patients suspected of infection with respiratory symptoms, at fifteen (15) clinical sites. To be enrolled in the study, patients had to present at the participating study site within five (5) days of symptom onset with signs and symptoms of respiratory infection generally observed from SARS-CoV-2, influenza A and/or influenza B, 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 a highly sensitive RT-PCR comparator assay. and the other swab was self-

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collected and tested immediately with the iHealth Flu A&B/COVID-19 Rapid Test per the test procedure. The collection order for the investigational and the comparator tests' swab was randomized. Subjects performed testing on self-collected swab samples in age groups 14 and older, and adult collected samples for age groups 2-13, in a simulated at-home environment. Out of 592 enrolled subjects, there were 588 evaluable subjects and 4 enrolled subjects were excluded.

b) Subject Demographics

Table 10. Subject Demographics

	Subjects (by lay-user collection and testing (N=343)	Self-collecting and testing (N=245)	Overall (N=588)
Age
Mean (SD)	9.9(12.4)	39.6(19.8)	22.3(21.6)
Median [Min, Max]	8[2,91]	38[14,87]	12[2,91]
Age Group
2-13 years of age	323(54.9%)	0(0%)	323(54.9%)
14-21 years of age	8(1.4%)	63(10.7%)	71(12.1%)
22-64 years of age	2(0.3%)	148(25.2%)	150(25.5%)
>64 years of age	10(1.7%)	34(5.8%)	44(7.5%)
Sex at Birth
Female	158(26.9%)	122(20.7%)	280(47.6%)
Male	185(31.5%)	123(20.9%)	308(52.4%)

The performance of the candidate test when compared to FDA-cleared highly sensitive RT-PCR molecular assays are presented in the tables below.

c) Clinical Performance

SARS-COV-2 PERFORMANCE

Table 11. Clinical Performance Compared to Reference PCR: SARS-CoV-2

SARS-CoV-2	Comparator Positives	Comparator Negatives	Sum
Candidate Positives	49	2	51
Candidate Negatives	4	533	537
Sum	53	535	588

Positive Percent Agreement (PPA) =92.5% (49/53), 95% CI (82.1%, 97.0%)
Negative Percent Agreement (NPA) = 99.6% (533/535), 95% CI (98.6%, 99.9%)

Table 12. SARS-CoV-2 Clinical Performance Stratified by Days Post Symptoms Onset

DPSO	Number of Subject samples tested	Candidate Positives	Comparator Positives	% Positive Rate (by Comparator)	PPA (95% CI)
Day 0	33	3	3	0.5%	100.0% (43.8%, 100%)

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| Day 1 | 156 | 19 | 19 | 3.2% | 100.0% (83.2%, 100%) |
| Day 2 | 202 | 9 | 12 | 2.0% | 75.0% (46.8%,91.1%) |
| Day 3 | 131 | 12 | 13 | 2.2% | 92.3% (66.7%, 98.6%) |
| Day 4 | 47 | 5 | 5 | 0.9% | 100.0% (56.6%,100%) |
| Day 5 | 19 | 1 | 1 | 0.2% | 100.0% (20.7%,100%) |
| Total | 588 | 49 | 53 | 9.0% | 92.5% (82.1%-97.0%) |

INFLUENZA A PERFORMANCE

Table 13. Clinical Performance Compared to Reference PCR: Influenza A

FLU A	Comparators Positives	Comparators Negatives	Sum
Candidate Positives	197	6	203
Candidate Negatives	29	356	385
Sum	226	362	588

Positive Percent Agreement (PPA) =87.2% (197/226), 95% CI (82.2%, 90.9%)
Negative Percent Agreement (NPA) = 98.3% (356/362), 95% CI (96.4%, 99.2%)

INFLUENZA B PERFORMANCE

Table 14. Clinical Performance Compared to Reference PCR: Influenza B

FLU B	Comparators Positives	Comparators Negatives	Sum
Candidate Positives	43	4	47
Candidate Negatives	7	534	541
Sum	50	538	588

Positive Percent Agreement (PPA) =86.0% (43/50), 95% CI (73.8%, 93.0%)
Negative Percent Agreement (NPA) = 99.3% (534/538), 95% CI (98.1%, 99.7%)

11.0 Other Supportive Information:

Flex Studies

To assess the robustness and risk for false results of the test when deviating from the test steps, flex studies were conducted that assessed all major aspects of the test procedure (sample volume, reading time, other deviations from the procedure [delay in mixing, uneven mixing, delay in addition of sample to the well, incubation time], variability of environmental test conditions that the test may be subjected to when in use [lighting, disturbance during use, temperature and humidity stress conditions, inadequate temperature equilibration, delayed use after opening the foil pouch], and interpretation by a colorblind user. Testing

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was performed with contrived positive nasal swabs generated by diluting SARS-CoV-2 virus into negative PNF at 2x LoD. False results are observed with too little sample volume and insufficient incubation time, specifically with less than two drops of sample and with less than ten minutes incubation. Additionally, if the swab was not thoroughly mixed in the reagent buffer tube, it could also lead to false results. The studies support that the test is robust in the intended use condition with an insignificant risk of erroneous result.

12.0 Conclusion

The information provided in this Premarket Notification demonstrates that the performance of the iHealth Flu A&B/COVID-19 Rapid Test and iHealth Flu A&B/COVID-19 Rapid Test Pro are substantially equivalent in intended use, technological characteristics and performance to the predicate device.

Regulation Number and Section

N/A