(93 days)
The WELLlife™ COVID-19 / Influenza A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of 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 nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out influenza, SARS-CoV-2, or other pathogens.
Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not subsitiute for a visit to a healthcare provider or appropriate follow-up.
The WELLlife™ COVID-19 / Influenza A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of 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.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out influenza, SARS-CoV-2, or other pathogens.
Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and or shortness of breath, should seek follow-up care from their healthcare 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 management decisions.
The WELLlife™ COVID-19 / Influenza A&B Home Test and the WELLlife™ COVID-19 / Influenza A&B Antigen Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. The test has two versions, one for over the counter (OTC) use, the (WELLlife™ COVID-19 / Influenza A&B Home Test), and one for professional use (WELLlife™ COVID-19 / Influenza Antigen A&B). Both versions of the WELLIife™ COVID-19 / Influenza A&B Tests that have an identical general design and are intended for the qualitative detection of nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with respiratory signs and symptoms within the first four (4) days of symptom onset. Results are for the identification and differentiation of nucleocapsid protein antigen from SARS-CoV-2, nucleoprotein antigen from influenza A virus, and nucleoprotein antigen from influenza B virus. The test cassette 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 CoV line) and a control line (C line). The device is for in vitro diagnostic use only. The device is for over-the-counter use.
The provided document describes the WELLlife COVID-19 / Influenza A&B Home Test and WELLlife COVID-19 / Influenza A&B Antigen Test. The following information is extracted regarding its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for molecular diagnostic devices like the WELLlife COVID-19 / Influenza A&B Home Test are typically established by the FDA and are generally expressed as minimum acceptable Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to a reference molecular assay (e.g., PCR). While specific numerical acceptance criteria are not explicitly stated in this document (e.g., "PPA must be >X%"), the clinical performance results are presented, and the conclusion states that the device's performance demonstrates substantial equivalence to the predicate device. Therefore, the reported performance is presented against an implicit expectation of high agreement.
| Performance Metric | Acceptance Criteria (Implicit for SARS-CoV-2, Flu A, Flu B) | Reported Device Performance (WELLlife COVID-19 / Influenza A&B Home Test) |
|---|---|---|
| SARS-CoV-2 PPA | High (e.g., typically >80%) | 87.8% (95% CI: 80.6% - 92.6%) |
| SARS-CoV-2 NPA | High (e.g., typically >98%) | 99.8% (95% CI: 99.1% - 100%) |
| Influenza A PPA | High (e.g., typically >80%) | 87.2% (95% CI: 78.5% - 92.7%) |
| Influenza A NPA | High (e.g., typically >98%) | 99.7% (95% CI: 98.8% - 99.9%) |
| Influenza B PPA | High (e.g., typically >80%) | 87.9% (95% CI: 72.7% - 95.2%) |
| Influenza B NPA | High (e.g., typically >98%) | 99.7% (95% CI: 98.9% - 99.9%) |
Note: The actual FDA acceptance criteria for PPA and NPA can vary based on test type, intended use, and public health context. The values listed under "Acceptance Criteria (Implicit)" represent typical expected ranges for such devices.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Clinical Performance Study: 787 enrolled subjects, with 705 evaluable subjects.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from "Wondfo USA Co., Ltd." in San Diego, California, implying the study was likely conducted in the USA.
- Retrospective or Prospective: Prospective study. Subjects were sequentially enrolled between December 2023 and March 2024, and samples were tested fresh.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The ground truth was established by an "FDA-cleared molecular comparator method," but details on the number or qualifications of experts involved in the molecular comparator testing, or explicit adjudication if necessary, are not mentioned.
4. Adjudication Method for the Test Set
This information is not explicitly provided. The document states that a healthcare professional collected a swab for testing using an "FDA-cleared molecular comparator method." The process for resolving discrepancies between the candidate device and the comparator method, or any other adjudication steps, is not detailed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This document describes a diagnostic test for detecting viral antigens, not an AI-powered diagnostic imaging device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with or without AI assistance is not applicable and was not performed. The device is a lateral flow immunoassay interpreted visually.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
The device is a lateral flow immunoassay that produces visible colored lines for interpretation. It is designed for "nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older." While it's a "standalone" device in the sense that it doesn't require a separate instrument or a healthcare professional for interpretation at home, it does rely on human visual interpretation (human-in-the-loop). Therefore, a "standalone algorithm only" performance is not applicable as there is no underlying algorithm in this context.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the clinical performance study was established using an "FDA-cleared molecular comparator method" (e.g., PCR).
8. The Sample Size for the Training Set
This document does not specify a separate "training set" in the context of machine learning. The non-clinical performance studies (Lot-to-Lot Precision, Limit of Detection, Inclusivity, Analytical Specificity) used various contrived and spiked samples. The clinical study used 705 evaluable subjects. For a lateral flow immunoassay, "training" typically refers to the development and optimization process involving chemical formulations, antibody selection, and manufacturing parameters, rather than a distinct data training set for a machine learning algorithm.
9. How the Ground Truth for the Training Set was Established
As noted above, a distinct "training set" in the machine learning sense is not described. For the analytical studies, ground truth (e.g., viral concentration, presence/absence of interferents) was established by spiking samples with known concentrations of viruses or other substances. For the clinical study, the reference standard was the result from an FDA-cleared molecular comparator method.
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January 16, 2025
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
Wondfo USA Co., Ltd. Kaiyu Xiao Senior Regulatory Affairs Manager 6720 Cobra Way San Diego, California 92121
Re: K243256
| Trade/Device Name: | WELLlife COVID-19 / Influenza A&B Home TestWELLlife COVID-19 / Influenza A&B AntigenTest |
|---|---|
| Regulation Number: | 21 CFR 866.3987 |
| Regulation Name: | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Regulatory Class: | Class II |
| Product Code: | SCA |
| Dated: | October 14, 2024 |
| Received: | October 15, 2024 |
Dear Kaiyu Xiao:
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 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).
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Sincerely,
Digitally signed by Silke Silke Schlottmann -S Schlottmann -S Date: 2025.01.16 18:19:24 -05'00' 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
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Indications for Use
510(k) Number (if known) K243256
Device Name
WeLLlife COVID-19 / Influenza A&B Home Test; WeLLlife CVOID-19 / Influenza A&B Antigen Test
Indications for Use (Describe)
WELLlife COVID-19 / Influenza A&B Home Test :
The WELLlife™ COVID-19 / Influenza A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of 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 nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out influenza, SARS-CoV-2, or other pathogens.
Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.
Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not subsitiute for a visit to a healthcare provider or appropriate follow-up.
WELLlife COVID-19 / Influenza A&B Antigen Test:
The WELLlife™ COVID-19 / Influenza A&B Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of 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.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out influenza, SARS-CoV-2, or other pathogens.
Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and or shortness of breath, should seek follow-up care from their healthcare 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 management decisions.
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.
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510(k) Summary
In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the following 510(k) Summary for WELLlife COVID-19 / Influenza A&B Home Test / WELLlife COVID-19 / Influenza A&B Antigen Test is provided:
Applicant Information
| Submitter Name | Wondfo USA Co., Ltd. |
|---|---|
| Address | 6720 Cobra WaySan Diego, CA, 92121 |
| Contact Person | Kaiyu XiaoSenior Regulatory Affairs ManagerTel: +86-15005196892E-mail: kaiyu@wondfousa.com |
| Date Prepared | January 9, 2025 |
Device Information
| Trade Name | WELLlife COVID-19 / Influenza A&B Home Test |
|---|---|
| WELLlife COVID-19 / Influenza A&B Antigen Test | |
| Common Name | Multi-analyte respiratory virus antigen detection test |
| Classification | Class II |
| Classification Name | Multi-analyte respiratory virus antigen detection test |
| Product Code | SCA |
| Regulation Number | 21 CFR 866.3987 |
| Review Panel | Microbiology |
Legally Marketed Predicate Device
| Trade Name | Healgen Rapid Check COVID-19/flu A&B Antigen Test |
|---|---|
| 510(k) Number | DEN240029 |
| Product Code | SCA |
| Review Panel | Microbiology |
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WELLlife™ COVID-19 / Influenza A&B Test
1 Device Description
The WELLlife™ COVID-19 / Influenza A&B Home Test and the WELLlife™ COVID-19 / Influenza A&B Antigen Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens. The test has two versions, one for over the counter (OTC) use, the (WELLlife™ COVID-19 / Influenza A&B Home Test), and one for professional use (WELLlife™ COVID-19 / Influenza Antigen A&B). Both versions of the WELLIife™ COVID-19 / Influenza A&B Tests that have an identical general design and are intended for the qualitative detection of nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with respiratory signs and symptoms within the first four (4) days of symptom onset. Results are for the identification and differentiation of nucleocapsid protein antigen from SARS-CoV-2, nucleoprotein antigen from influenza A virus, and nucleoprotein antigen from influenza B virus. The test cassette 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 CoV line) and a control line (C line). The device is for in vitro diagnostic use only. The device is for over-the-counter use.
Indications for Use 2
The WELLlife™ COVID-19 / Influenza A&B Home Test:
The WELLlife™ COVID-19 / Influenza A&B Home 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.
The WELLlife™ COVID-19 / Influenza A&B Antigen Test:
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
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WELLlife™ COVID-19 / Influenza A&B Test
aged 14 years or older testing themselves, or adults testing 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 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.
3 Comparison to Predicate Device
The WELLlife™ COVID-19 / Influenza A&B Home Test / WELLlife™ COVID-19 / Influenza A&B Antigen Test is substantially equivalent in principle and performance to Healgen Rapid Check COVID-19/Flu A&B Antigen Test (DEN240029) which had been granted by FDA. The comparison to predicate device is as follows the table below:
| Predicate Device | Candidate Device | |
|---|---|---|
| Item | Healgen Rapid Check | WELLlife COVID-19 / Influenza A&B Home Test |
| COVID-19/Flu A&B | WELLlife COVID-19 / Influenza A&B Antigen | |
| Antigen Test (DEN240029) | Test. | |
| IntendedUse/Indicationsfor Use | The Healgen Rapid CheckCOVID-19/Flu A&BAntigen Test is a lateral flowimmunochromatographicassay intended for thequalitative detection anddifferentiation of influenza A,and influenza Bnucleoprotein antigens andSARS-CoV-2 nucleocapsidantigen directly in anteriornasal swab samples fromindividuals with signs andsymptoms of respiratory tractinfection. Symptoms ofrespiratory infections due toSARS-CoV-2 and influenzacan be similar. This test is fornon-prescription home use byindividuals aged 14 years orolder testing themselves, or | The WELLlife™ COVID-19 / Influenza A&BHome Test is a lateral flowimmunochromatographic assay intended for thequalitative detection and differentiation of influenzaA, and influenza B nucleoprotein antigens andSARS-CoV-2 nucleocapsid antigen directly inanterior nasal swab samples from individuals withsigns and symptoms of respiratory tract infection.Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is fornon-prescription home use by individuals aged 14years or older testing themselves, or adults testingindividuals aged 2 years or older.All negative results are presumptive and should beconfirmed with an FDA-cleared molecular assaywhen determined to be appropriate by a healthcareprovider. Negative results do not rule out infectionwith influenza, SARS-CoV-2 or other pathogens.Individuals who test negative and experiencecontinued or worsening respiratory symptoms, suchas fever, cough and/or shortness of breath, shouldseek follow-up care from their healthcare provider. |
| adults testing individualsaged 2 years or older.All negative results arepresumptive and should beconfirmed with an FDA-cleared molecular assay whendetermined to be appropriateby a healthcare provider.Negative results do not ruleSARS-CoV-2 or otherpathogens.Individuals who test negativeand experience continued orworsening respiratorysymptoms, such as fever,cough and/or shortness ofbreath, should seek follow-upcare from their healthcareprovider.Positive results do not ruleout co-infection with otherrespiratory pathogens, and therefore do not substitute fora visit to a healthcareprovider or appropriatefollow-up. | Positive results do not rule out co-infection withother respiratory pathogens, and therefore do notsubstitute for a visit to a healthcare provider orappropriate follow-up.The WELLlifeTM COVID-19 / Influenza A&BAntigen Test is a lateral flowimmunochromatographic assay intended for thequalitative detection and differentiation of influenzaA, and influenza B nucleoprotein antigens andSARS-CoV-2 nucleocapsid antigen directly inanterior nasal swab samples from individuals withsigns and symptoms of respiratory tract infection.Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is foruse by individuals aged 14 years or older testingthemselves, or adults testing aged 2 years or older.All negative results are presumptive and should beconfirmed with an FDA-cleared molecular assaywhen determined to be appropriate by a healthcareprovider. Negative results do not rule out infectionwith influenza, SARS-CoV-2, or other pathogens.Individuals who test negative and experiencecontinued or worsening respiratory symptoms, suchas fever, cough and/or shortness of breath, shouldseek follow-up care from their healthcare providers.Positive results do not rule out co-infection withother respiratory pathogens.Test results should not be used as the sole basis fortreatment or other patient management decisions. | |
| RegulationNumber | 21 CFR 866.3987 | Same |
| DiseasePopulation | Respiratory tract infection | Same |
| Intendedusers / UserEnvironment | OTC Lay User | Same |
| TestPrinciple | Lateral flow immunoassay | Same |
| Sample type | Anterior nasal swabspecimens | Same |
| Assaytargets | SARS-CoV-2 nucleocapsidprotein antigensNucleoprotein antigen frominfluenza A virusNucleoprotein antigen frominfluenza B virus | Same |
| Assay Type | Qualitative | Same |
Table 1: Comparison with Predicate Device
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| Wondfo USA Co., Ltd. | 510(k) Summary |
|---|---|
| WELLife TM COVID-19 / Influenza A&B Test |
| Mode ofResults | Visual | Same |
|---|---|---|
| AssayControl | Internal procedural control | Same |
| StorageTemperature | 2°C to 30°C | Same |
| Differences | ||
| Time toResult | 15 minutes - 20 minutes | 10 minutes - 20 minutes |
Operation Principle 4
The WELLlife™ COVID-19 / Influenza A&B Home Test / WELLlife™ COVID-19 / Influenza A&B Antigen Test (generically referred to as WELLlife™ COVID-19 / Influenza A&B Tests for the remainder of this document) consist of a test cassette that separately detects influenza A, influenza B, and SARS-CoV-2 antigens. The test procedure requires the anterior nasal swab specimen to be inserted into the prefilled extraction buffer tube to be solubilized, and then the specimen is eluted. The virus particles in the specimen are disrupted by the chemicals in the extraction buffer, exposing internal viral nucleoproteins. After the release of specimen, the swab is discarded. The extracted specimen is then dropped into the sample well of the test cassette.
If SARS-CoV-2, influenza A and/or influenza B antigens are present in the specimen, they will react with SARS-CoV-2 antibody coupled to dye particles and/or influenza antibody coupled to dye particles, migrate through the membrane as antigen-antibodydye complexes, bind to the immobilized capture antibody line(s) on the membrane, and generate a colored pink to red line in the specific test line position. The rest of the sample and rabbit IgG dye particle complexes continue to migrate to the Control line position (C), where immobilized goat anti-rabbit IgG will capture the rabbit IgG dye particle complexes and form the Control line. Formation of the pink to red Control line serves as an internal control to demonstrate that test reagents are functional, antibodydye conjugates in the dye 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.
If the antigen level is equal to or above the detection limit, a visible colored band appears at the test region. Absence of this pink to red colored band in the test region of test strip and only a visible control line will appear, suggests a negative result.
WELLlife™ COVID-19 / Influenza A&B Home Test has three Test lines, one for COVID-19, one for influenza A and one for influenza B. The three Test lines allow for the separate and differential identification of COVID-19, influenza A and/or B from a single specimen. If any Test line appears in the test result window, together with the Control line, the test result is positive for COVID-19 and/or influenza.
Results can be interpreted between 10 and 20 minutes after adding the extracted sample into the sample well.
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5 Non-clinical Performance
The WELLlife™ COVID-19 / Influenza A&B Home Test and the WELLlife™ COVID-19 / Influenza A&B Antigen Test are generally identical in design but have slightly different instructions to accommodate lay users and professional users. The following performance data were generated using the WELLlife™ COVID-19 / Influenza A&B Home Test and its QRI, but are applicable to both versions/configurations of the test.
5.1 Lot-to-Lot Precision
A single-site lot-to-lot precision study was conducted to measure repeatability using three levels of contrived samples. A panel of three samples was tested: a negative sample (PNSM only), low positive sample (2x co-spike LoD of all analytes), moderate positive sample (5x co-spike LoD of all analytes). The strains used for testing were UVinactivated SARS-CoV-2 USA-WA1/2020, live influenza A H1N1, and live influenza B Yamagata. One replicate per sample type was tested per run, per operator, and per lot across 10 days with two test runs per day for a total of 120 results per sample type (3 lots x 2 operators x 1 replicate x 10 days x 2 runs per day).
In addition, a supplemental precision study was conducted testing negative samples, a sample with spiked 0.9 x LoD SARS-CoV-2 and 0.8 x LoD Flu B and a sample spiked with 0.9 x LoD Flu A 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).
Repeatability was determined by comparing test results to expected results across all lots, operators, and days. Results are shown in the table below.
| % Agreement with Expected Result | |||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sample | Analyte | Lot 1 | Lot 2 | Lot 3 | Total | ||||||||||||||||||||||||||
| Negative | SARS-CoV-2 | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | ||||||||||||||||||||||||||
| Flu A | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | |||||||||||||||||||||||||||
| Flu B | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | |||||||||||||||||||||||||||
| 2x LoD | SARS-CoV-2 | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | ||||||||||||||||||||||||||
| Flu A | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | |||||||||||||||||||||||||||
| Flu B | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | |||||||||||||||||||||||||||
| 5x LoD | SARS-CoV-2 | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | ||||||||||||||||||||||||||
| Flu A | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | |||||||||||||||||||||||||||
| Flu B | 40/40 (100%) | 40/40 (100%) | 40/40 (100%) | 120/120 (100%) | |||||||||||||||||||||||||||
| Negative | SARS-CoV-2 | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | Flu A | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | Flu B | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | <1X LoDSARS-CoV-2and Flu B Co-Spiked | SARS-CoV-2 | 16/24 (67%) | 22/24 (92%) | 20/24 (83%) | 58/72 (81%) | Flu A | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | Flu B | 22/24 (92%) | 23/24 (96%) | 18/24 (75%) | 63/72 (88%) |
| Negative | SARS-CoV-2 | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | ||||||||||||||||||||||||||
| Flu A | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | |||||||||||||||||||||||||||
| Flu B | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | |||||||||||||||||||||||||||
| <1X LoDSARS-CoV-2and Flu B Co-Spiked | SARS-CoV-2 | 16/24 (67%) | 22/24 (92%) | 20/24 (83%) | 58/72 (81%) | Flu A | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | Flu B | 22/24 (92%) | 23/24 (96%) | 18/24 (75%) | 63/72 (88%) | ||||||||||||||||
| <1X LoDSARS-CoV-2and Flu B Co-Spiked | SARS-CoV-2 | 16/24 (67%) | 22/24 (92%) | 20/24 (83%) | 58/72 (81%) | ||||||||||||||||||||||||||
| Flu A | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) | |||||||||||||||||||||||||||
| Flu B | 22/24 (92%) | 23/24 (96%) | 18/24 (75%) | 63/72 (88%) |
| Table 2: Summary of Lot-Lot Precision Results | |||
|---|---|---|---|
| ----------------------------------------------- | -- | -- | -- |
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510(k) Summary
| Sample | Analyte | % Agreement with Expected Result | |||
|---|---|---|---|---|---|
| Lot 1 | Lot 2 | Lot 3 | Total | ||
| <1X LoD FluA | SARS-CoV-2 | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) |
| <1X LoD FluA | Flu A | 20/24 (83%) | 24/24 (100%) | 19/24 (79%) | 63/72 (88%) |
| <1X LoD FluA | Flu B | 24/24 (100%) | 24/24 (100%) | 24/24 (100%) | 72/72 (100%) |
5.2 Analytical Sensitivity: Limit of Detection
a) Limitation of Detection
The limit of detection (LoD) for SARS-CoV-2 and influenza A and B in WELLlife™ COVID-19 / Influenza A&B Home Test was determined by evaluating different concentrations of UV-inactivated SARS-CoV-2 and live influenza A and B viruses. The viruses were diluted in pooled negative swab matrix (PNSM) to generate virus dilutions for testing. Anterior nasal swab samples were prepared by adding 50μL of each virus dilution onto the sterile swab. The swab samples were tested according to the test procedure in package insert. Range-finding testing was conducted with three replicates at various dilutions and confirmatory testing was conducted with 20 replicates. The lowest concentration that generated ≥95% positive detection rate was set as the LoD concentration.
| Virus Strains | StockConcentration(TCID50/mL) | LoD(TCID50/mL) | LoD(TCID50/Swab) | #Positive/#Total | PercentDetected(%) |
|---|---|---|---|---|---|
| SARS-CoV-2 USA-WA1/2020(UV inactivated) | 3.16×106 | 7.90×102 | 39.5 | 60/60 | 100% |
| Influenza AA/Victoria/4897/2022(H1N1)(live) | 2.02×105 | 1.01×102 | 5.05 | 60/60 | 100% |
| Influenza AA/Darwin/6/2021(H3N2)(live) | 4.17×105 | 2.09×102 | 10.45 | 60/60 | 100% |
| Influenza BB/Washington/02/2019(Victoria)(live) | 3.16×106 | 3.16×103 | 158 | 60/60 | 100% |
| Influenza B B/Florida/4/2006(Yamagata)(live) | 1.17×105 | 5.85×101 | 2.93 | 60/60 | 100% |
Table 3: Summary of Limit of Detection (LoD) Results
b) 1st WHO International Standard for SARS-CoV-2 antigen (NIBSC code: 21/368)
A preliminary LoD concentration of the WELLlife™ COVID-19 / Influenza A&B tests for the 1st WHO International Standard for SARS-CoV-2 antigen is determined by testing a series of 2-fold dilutions, starting with a 5-fold dilution from the stock
{12}------------------------------------------------
concentration (20,000 IU/mL) of the International Standard, spiked into PNSM. The lowest 2-fold dilution concentration at which all three replicates test positive is identified as the preliminary 1X LoD. The preliminary 1X LoD, and two concentrations (preliminary 0.33X LoD and preliminary 3X LoD) were confirmed by testing an additional twenty (20) spiked PNSM samples.
Table 4: Summary of LoD Results with the 1st WHO International Standard for SARS-CoV-2 Antigen (NIBSC code:21/368)
| Concentration of WHO International Standard forSARS-CoV-2 antigen | Positive results / Total | |
|---|---|---|
| IU/mL | IU/Swab | |
| $5x10^2$ IU/mL | 25 | 20/20 |
c) Inclusivity
The analytical reactivity of the antibodies targeting Influenza A, influenza B, and SARS-CoV-2 in WELLIife™ COVID-19 / Influenza A&B Home Test was evaluated with the currently available strains.
| Influenza Virus(Type/Subtype) | Virus Strain Name | MinimumDetectableConcentration | Positive/Replicates |
|---|---|---|---|
| SARS-CoV-2(XBB.1.5) | hCoV-19/USA/MD-HP40900/2022 | $7.8 x10^1$ TCID50/mL | 10/10 |
| SARS-CoV-2(JN.1) | JN.1 variant derived from clinical sample | $9.18 x 10^4$ GE/mL | 5/5 |
| A(H1N1)pdm09 | A/California/04/2009 | $2.80 x10^3$ TCID50/mL | 3/3 |
| A/Brisbane/02/18 | $1.51 x10^2$ TCID50/mL | 3/3 | |
| A/Michigan/45/15 | $1.86 x10^1$ TCID50/mL | 3/3 | |
| A/Guangdong-Maonan/SWL1536/19 | $2.09 x10^2$ TCID50/mL | 3/3 | |
| A/NY/03/09 | $2.29 x10^4$ TCID50/mL | 3/3 | |
| A/Indiana/02/2020 | $9.70 x10^6$ CEID50/mL | 3/3 | |
| A/Wisconsin/588/2019 | $7.00 x10^3$ FFU/mL | 3/3 | |
| A/Sydney/5/2021 | $4.80 x10^3$ TCID50/mL | 3/3 | |
| A/Hawaii/66/2019 | $1.85 x10^7$ CEID50/mL | 3/3 | |
| A(H3N2) | A/Wisconsin/67/22 | $4.21 x10^2$ TCID50/mL | 3/3 |
| A/Tasmania/503/2020 | $1.30 x10^5$ FFU/mL | 3/3 | |
| A/New York/21/2020 | $2.60 x10^5$ FFU/mL | 3/3 | |
| A/Alaska/01/2021 | $3.75 x10^4$ FFU/mL | 3/3 | |
| A/Hong Kong/45/2019 | $1.50 x10^4$ FFU/mL | 3/3 | |
| A/Hong Kong/2671/19 | $1.05 x10^3$ TCID50/mL | 3/3 |
Table 5: Summary of Inclusivity Results
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WELLlife™ COVID-19 / Influenza A&B Test
| Influenza Virus(Type/Subtype) | Virus Strain Name | MinimumDetectableConcentration | Positive/Replicates |
|---|---|---|---|
| A/Indiana/08/2011 | $8.10 x10^2$ TCID50/mL | 3/3 | |
| A(H1N1) | A/Ohio/09/2015 | $7.00 x10^5$ CEID50/mL | 3/3 |
| A(H1N2) | A/Minnesota/19/2011 | $4.00 x10^6$ CEID50/mL | 3/3 |
| A(H5N1) | A/mallard/Wisconsin/2576/2009 | $4.00 x10^5$ CEID50/mL | 3/3 |
| A/duck/Guangxi/S11002/2024 | $3.38 x10^5$ EID50/mL | 3/3 | |
| A(H5N6) | A/duck/Guangxi/S10888/2024 | $6.76 x10^5$ EID50/mL | 3/3 |
| A(H5N8) | A/goose/Liaoning/S1266/2021 | $6.76 x10^5$ EID50/mL | 3/3 |
| A(H7N3) | A/northernpintail/Illinois/10OS3959/2010 | $7.00 x10^5$ CEID50/mL | 3/3 |
| B(Non Victoriaand NonYamagata) | B/Maryland/1/59 | $3.38 x10^3$ CEID50/mL | 3/3 |
| B/Brisbane/60/2008 | 1.29 TCID50/mL | 3/3 | |
| B(Victorialineage) | B/Colorado/06/17 | $5.85 x10^1$ TCID50/mL | 3/3 |
| B/Texas/02/2013 | $2.45 x10^1$ TCID50/mL | 3/3 | |
| B/Michigan/01/2021 | $1.43 x10^4$ TCID50/mL | 3/3 | |
| B(Yamagatalineage) | Yamagata - B/Texas/06/2011 | $7.55 x10^2$ TCID50/mL | 3/3 |
| Yamagata - B/Utah/09/2014 | $1.26 x10^3$ TCID50/mL | 3/3 | |
| B/Wisconsin/01/2010 | $1.78 x10^2$ TCID50/mL | 3/3 |
5.3 Analytical Specificity
a) Microorganism Cross-Reactivity and Microbial Interference
Cross-reactivity of the WELLlife™ COVID-19 / Influenza A&B Home Test was evaluated by testing a panel of related pathogens, high prevalence disease agents, and normal or pathogenic flora that are reasonably likely to be encountered in clinical specimens and could potentially cross-react with the WELLlife™ COVID-19 / Influenza A&B Home Test including twenty (20) bacteria, twenty (20) viruses and one (1) negative matrix. Each organism and virus were tested in triplicate the absence (cross-reactivity) or presence (interference) of co-spiked UV-inactivated SARS-CoV-2, influenza A, and B at 3 x LoD. No cross-reactivity was observed with the listed microorganisms when tested at the concentration presented in the table below. No interference was observed with the listed microorganisms when tested at the concentration presented in the table below in the presence of the target analytes.
| Potential Cross-Reactant | Concentration Tested |
|---|---|
| SARS-CoV-1 | 1.25 x105 PFU/ml |
| MERS-coronavirus | 1.47 x105 TCID50/mL |
| Human coronavirus HKU1 | 1.74 x107 GE/mL (Ct 20.7) |
| Potential Cross-Reactant | Concentration Tested |
| Human coronavirus OC43 | 7.00 x105 TCID50/mL |
| Human coronavirus 229E | 1.58 x105 TCID50/mL |
| Human coronavirus NL63 | 7.05 x104 TCID50/mL |
| Adenovirus Type 1 | 2.23 x105 TCID50/mL |
| Adenovirus Type 7 | 1.58 x105 TCID50/mL |
| Cytomegalovirus | 7.05 x104 TCID50/mL |
| Epstein Barr Virus | 1.83 x106 CP/mL |
| Human Metapneumovirus | 3.50 x105 TCID50/mL |
| Parainfluenza virus 1 | 2.00 x105 TCID50/mL |
| Parainfluenza virus 2 | 1.75 x105 TCID50/mL |
| Parainfluenza virus 3 | 7.00 x105 TCID50/mL |
| Parainfluenza virus 4 | 2.39 x105 TCID50/mL |
| Enterovirus Type 68 | 2.23 x105 TCID50/mL |
| Respiratory syncytial virus A | 3.50 x105 TCID50/mL |
| Respiratory syncytial virus B | 2.29 x105 TCID50/mL |
| Rhinovirus 1A | 7.05 x104 TCID50/mL |
| Bordetella pertussis | 2.90 x108 CFU/mL |
| Candida albicans | 1.21 x107 CFU/mL |
| Chlamydia pneumoniae | 4.33 x106 IFU/mL |
| Corynebacterium xerosis | 2.30 x107 CFU/mL |
| Escherichia coli | 1.79 x108 CFU/mL |
| Hemophilus influenzae | 9.68 x106 CFU/mL |
| Lactobacillus Acidophilus | 1.21 x107 CFU/mL |
| Legionella spp pneumophila | 6.50 x106 CFU/mL |
| Moraxella catarrhalis | 2.50 x108 CFU/mL |
| Mycoplasma pneumoniae | 2.50 x107 CFU/mL |
| Mycobacterium tuberculosis avirulent | 3.03 x106 CFU/mL |
| Neisseria meningitidis | 3.43 x106 CFU/mL |
| Neisseria sp. Elongata | 2.68 x108 CFU/mL |
| Pneumocystis jirovecii | 1.30 x107 CFU/mL |
| Pseudomonas aeruginosa | 3.45 x108 CFU/mL |
| Staphylococcus aureus subsp. aureus | 2.60 x108 CFU/mL |
| Staphylococcus epidermidis | 9.00 x107 CFU/mL |
| Streptococcus salivarius | 1.01 x106 CFU/mL |
| Streptococcus pneumoniae | 1.81 x107 CFU/mL |
| Streptococcus pyogenes | 7.50 x107 CFU/mL |
| Measles | 8.48 x105 TCID50/mL |
| Mumps | 8.48 x105 TCID50/mL |
| Pooled Negative Nasal Wash | NA |
{14}------------------------------------------------
WELLlife™ COVID-19 / Influenza A&B Test
{15}------------------------------------------------
b) Competitive Interference
For co-infection, SARS-CoV-2 at levels near LoD was tested in the presence of high levels of influenza A or influenza B and influenza A and influenza B at levels near LoD were tested in the presence of high levels of SARS-CoV-2. No competitive interference was seen between high levels of SARS-CoV-2 and low levels of Influenza A and B and between high levels of Influenza A and low levels of SARS-CoV-2 and influenza B in this testing at the concentration listed in the tables below. Competitive inhibition were observed between high levels of influenza B(Yamagata Lineage) and low levels of Influenza A in this testing at the concentration listed in the tables below.
| SARS-CoV-2(USA-WA1/2020) | PercentAgreement | Influenza A Virus(H1N1pdm09)A/Victoria/4897/2022 | PercentAgreement | Influenza B Virus(Yamagata Lineage)B/Florida/4/2006 | PercentAgreement |
|---|---|---|---|---|---|
| Concentration(TCID50/mL) | Concentration(TCID50/mL) | Concentration(TCID50/mL) | |||
| Negative | 100% | 6.73x104 | 100% | 1.76 x102 | 100% |
| 2.37x103 | 100% | 6.73x104 | 100% | Negative | 100% |
| 2.37x103 | 100% | 6.73x104 | 100% | 1.76 x102 | 100% |
| Negative | 100% | 3.03x102 | 0 | 3.90 x104 | 100% |
| Negative | 100% | 3.03x102 | 0 | 1.95 x104 | 100% |
| Negative | 100% | 3.03x102 | 100% | 7.80 x103 | 100% |
| Negative | 100% | 3.03x102 | 100% | 3.90 x103 | 100% |
| 2.37x103 | 100% | Negative | 100% | 3.90 x104 | 100% |
| 2.37x103 | 100% | 3.03x102 | 0 | 3.90 x104 | 100% |
| 2.37x103 | 100% | 3.03x102 | 0 | 1.95 x104 | 100% |
| 2.37x103 | 100% | 3.03x102 | 100% | 7.80 x103 | 100% |
| 2.37x103 | 100% | 3.03x102 | 100% | 3.90 x103 | 100% |
| 1.05x106 | 100% | 3.03x102 | 100% | Negative | 100% |
| 1.05x106 | 100% | Negative | 100% | 1.76 x102 | 100% |
| 1.05x106 | 100% | 3.03x102 | 100% | 1.76 x102 | 100% |
Table 7: Summary of Competitive Interference Study Results of SARS-CoV-2&Influenza A &Influenza B Virus (Yamagata Lineage)
Table 8: Summary of Competitive Interference Study Results SARS-CoV-2&Influenza A &Influenza B Virus (Victoria Lineage)
| SARS-CoV-2(USA-WA1/2020) | Influenza A Virus(H1N1pdm09)A/Victoria/4897/2022 | Influenza B Virus(Victoria Lineage)B/Washington/02/19 | |||
|---|---|---|---|---|---|
| Concentration(TCID50/mL) | PercentAgreement | Concentration(TCID50/mL) | PercentAgreement | Concentration(TCID50/mL) | PercentAgreement |
| Negative | 100% | $6.73 \times 10^4$ | 100% | $3.51 \times 10^2$ | 100% |
| $2.37 \times 10^3$ | 100% | $6.73 \times 10^4$ | 100% | Negative | 100% |
| $2.37 \times 10^3$ | 100% | $6.73 \times 10^4$ | 100% | $3.51 \times 10^2$ | 100% |
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WELLlife™ COVID-19 / Influenza A&B Test
| SARS-CoV-2(USA-WA1/2020) | Influenza A Virus(H1N1pdm09)A/Victoria/4897/2022 | Influenza B Virus(Victoria Lineage)B/Washington/02/19 | |||
|---|---|---|---|---|---|
| Concentration(TCID50/mL) | PercentAgreement | Concentration(TCID50/mL) | PercentAgreement | Concentration(TCID50/mL) | PercentAgreement |
| Negative | 100% | $3.03 x10^2$ | 100% | $1.05 x10^6$ | 100% |
| $2.37 x10^3$ | 100% | Negative | 100% | $1.05 x10^6$ | 100% |
| $2.37 x10^3$ | 100% | $3.03 x10^2$ | 100% | $1.05 x10^6$ | 100% |
| $1.05 x10^6$ | 100% | $3.03 x10^2$ | 100% | Negative | 100% |
| $1.05 x10^6$ | 100% | Negative | 100% | $3.51 x10^2$ | 100% |
| $1.05 x10^6$ | 100% | $3.03 x10^2$ | 100% | $3.51 x10^2$ | 100% |
c) Interfering Substances
The potential interference of endogenous substances with the antibodies used for the detection of SARS-CoV-2, influenza A and B was examined by testing nineteen (19) substances in a negative clinical matrix in triplicate, in the absence or presence of each virus at 3 x LoD concentrations for SARS-CoV-2, influenza A(H1N1), and influenza B(Yamagata). The interference study was conducted using medically relevant concentrations of the potentially interfering substances listed below to assess the potential interference of the substances on the performance of the WELLlife™ COVID-19 / Influenza A&B Home Test.
At 15% (v/v) and when diluted down to 0.75% (v/v), FluMist Quadrivalent Live Intranasal Influenza Virus Vaccine vielded false positive results for Influenza A and Influenza B. At a dilution of 0.375% (v/v), the results were negative. Hand sanitizer containing 80% ethanol yielded false positive results for SARS-CoV-2 and Influenza B at a dilution of 15% (v/v) and when diluted down to 3.75% (v/v). At a dilution of 1.875% (v/v), the results were negative. At 15% (v/v) and when diluted down to 5% (v/v), the Zinc (TheraZinc Throat Spray) yielded false positive results for influenza A. At a dilution of 2.5% v/v, the results were negative. At 15% (v/v), the nasal corticosteroid (Fluticasone) yielded false negative results for SARS-CoV-2, Influenza A and Influenza B. At a dilution of 5%v/v, the results were positive. Two interferents produced falsenegative results for Influenza B: hand sanitizer cream lotion (15% v/v) and hand soap liquid gel (10% w/v). All Influenza B results were positive when tested with 7.5% (v/v) hand sanitizer cream lotion and 0.05% (w/v) hand soap liquid gel.
No interference was observed with the other listed substances when tested at the concentration presented in the table below in the presence or absence of the target analytes.
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WELLlife™ COVID-19 / Influenza A&B Test
| Potential Interferent | Concen-tration | Cross-reactivity(no analyte)(# pos reps / total reps) | Interference(3x LoD co-spikedanalytes)(# pos reps / total reps) | ||||
|---|---|---|---|---|---|---|---|
| SCV-2* | Flu A | Flu B | SCV-2 | Flu A | Flu B | ||
| Human Whole Blood (EDTAtube) | 4% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Mucin | 0.50% | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Chloraseptic(Menthol/Benzocaine) | 1.5mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Naso GEL (NeilMed) | 5% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Nasal Drops (Phenylephrine) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Nasal Spray (Oxymetazoline) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Nasal Spray (Cromolyn) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Zicam | 5% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Homeopathic (Alkalol) | 10% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Sore Throat Phenol Spray | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Tobramycin | 4 $ μ $ g/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Mupirocin | 10 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Fluticasone Propionate | 5% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Tamiflu (OseltamivirPhosphate) | 5 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| FluMist/ FluMist QuadrivalentLive intranasal influenza virusvaccine | 15% v/v0.375%v/v | 0/3 | 3/3 | 3/3 | 3/3 | 3/3 | 3/3 |
| Zanamivir | 282 ng/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Biotin | 3,500ng/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Body & Hand Lotion | 0.5% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Body Lotion, with 1.2%dimethicone | 0.5% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Hand Lotion | 5% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Hand Sanitizer with Aloe, 62%ethyl alcohol | 5% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Hand Sanitizer cream lotion | 15% v/v7.5% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Hand Sanitizer, 80% ethanol,fast drying | 15% v/v1.875%v/v | 3/3 | 0/3 | 2/3 | 3/3 | 3/3 | 3/3 |
| Hand soap liquid gel | 10% w/v0.05% w/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 0/3 |
| Throat lozenges(Menthol/Benzocaine) | 3 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Mucin from bovinesubmaxillary glands Type I-S | 2.5mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Leukocytes | 1x10 $^{6}$ | 0/2 | 0/3 | 0/3 | 2/2 | 2/2 | 2/2 |
| Potential Interferent | Concen-tration | Cross-reactivity(no analyte)(# pos reps / total reps) | Interference(3x LoD co-spikedanalytes)(# pos reps / total reps) | ||||
| SCV-2* | Flu A | Flu B | SCV-2 | Flu A | Flu B | ||
| cells/mL | |||||||
| $5\times10^5$cells/mL | - | - | - | 3/3 | 3/3 | 3/3 | |
| 15% v/v | 0/3 | 3/3 | 0/3 | 3/3 | 3/3 | 3/3 | |
| 5% v/v | 0/3 | 3/3 | 0/3 | - | - | - | |
| Zinc (TheraZinc Throat Spray) | 2.5% v/v | 0/3 | 0/3 | 0/3 | - | - | - |
| 1.5% v/v | 0/3 | 0/3 | 0/3 | - | - | - | |
| Nasal spray (Saline) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Dexamethasone (Nasalcorticosteroid) | 1 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Nasal corticosteroid(Triamcinolone) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Nasal corticosteroid | 15% v/v | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 | 0/3 |
| (Fluticasone) | 5% v/v | - | - | - | 3/3 | 3/3 | 3/3 |
| Nasal gel (Galphimia glauca,Histanium hydrocloricum,Luffa operculata, Sulfur) | 0.01 | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Zicam nasal spray (Galphimiaglauca, Luffa operculata) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Nasal spray (Alkalol) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Homeopathic allergy relief(Histaminum hydrochloricum) | 15% v/v | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
| Anti viral drug (Remdesivir) | 10 mg/mL | 0/3 | 0/3 | 0/3 | 3/3 | 3/3 | 3/3 |
Table 9: Summary of Interfering Substances Study Results
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WELLlife™ COVID-19 / Influenza A&B Test
*SCV-2: SARS-CoV-2
Clinical Performance 6
a) Clinical Study Design
A prospective study was performed in which seven hundred eighty-seven (787) study subjects were sequentially enrolled (between December 2023 and March 2024) and tested fresh. Anterior nasal swab (ANS) samples were collected from symptomatic patients suspected of infection with respiratory symptoms, at nine (9) clinical sites. To be enrolled in the study, patients had to present at the participating study site within four (4) 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 an FDA-cleared molecular comparator method, and the other swab was self-collected and tested immediately with the WELLlife™ COVID-19 / Influenza A&B Home Test per its summary instruction (QRI) test procedure. The collection order for the investigational and the comparator tests' ANS swab was randomized. Subjects performed testing on
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WELLlife™ COVID-19 / Influenza A&B Test
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 787 enrolled subjects, there were 705 evaluable subjects and 82 enrolled subjects were excluded.
b) Subject Demographics
| Table 10: Subject Demographics | |
|---|---|
| -------------------------------- | -- |
| Characteristic | Lay-user/ TesterCollectionN=160 | Self-CollectingN=545 | OverallN=705 |
|---|---|---|---|
| Age | |||
| Mean (SD) | 8.7 (4.5) | 45.8 (18.6) | 37.4 (22.6) |
| Median[Min, Max] | 8[2, 32] | 43[14, 94] | 35[2, 94] |
| Age Group | |||
| <14 | 139 (86.9%) | 0 | 139(19.7%) |
| 14-24 | 20 (12.5%) | 79 (14.5%) | 99 (14.0%) |
| 25-64 | 1 (0.6%) | 351 (64.4%) | 352(49.9%) |
| >64 | 0 | 115 (21.1%) | 115(16.3%) |
| Six at Birth | |||
| Female | 90 (56.3%) | 343 (62.9%) | 433(61.4%) |
| Male | 70 (43.8%) | 202 (37.1%) | 272(38.6%) |
| Ethnicity | |||
| Hispanic/Latino | 87 (54.4%) | 226 (41.5%) | 313(44.4%) |
| Not Hispanic/Latino | 73 (45.6%) | 304 (55.8%) | 377(53.5%) |
| Unknown/Prefernottoanswer | 0 | 15 (2.8%) | 15 (2.1%) |
| Race | |||
| American Indian or AlaskanNative | 0 | 2(0.4%) | 2(0.3%) |
| Asian | 19 (11.9%) | 150 (27.5%) | 169(24.0%) |
| Black or African American | 36 (22.5%) | 85 (15.6%) | 121(17.2%) |
| White | 101 (63.1%) | 267 (49.0%) | 368(52.2%) |
| Native Hawaiian or OtherPacific Islander | 0 | 0 | 0 |
| More than one race | 1 (0.6%) | 5 (0.9%) | 6 (0.9%) |
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WELLlife™ COVID-19 / Influenza A&B Test
| Characteristic | Lay-user/ TesterCollectionN=160 | Self-CollectingN=545 | OverallN=705 |
|---|---|---|---|
| Unknown/Prefer not toanswer | 2 (1.3%) | 30 (5.5%) | 32 (4.5%) |
| Other | 1 (0.6%) | 6 (1.1%) | 7 (1.0%) |
c) Clinical Performance
SARS-COV-2 PERFORMANCE
Table 11: WELLlife™ COVID-19 / Influenza A&B Home Test performance compared to reference PCR: SARS-CoV-2
| SARS-CoV-2 | ComparatorPositives | ComparatorNegatives | Total |
|---|---|---|---|
| Candidate Positives | 101 | 1 | 102 |
| Candidate Negatives | 14 | 589 | 603 |
| Total | 115 | 590 | 705 |
| Positive Percent Agreement (PPA) = 87.8% (101/115) 95% CI: 80.6% - 92.6% | |||
| Negative Percent Agreement (NPA) = 99.8% (589/590) 95% CI: 99.1% - 100% |
Table 12: SARS-CoV-2 Performance stratified by Days Post Symptoms Onset
| Days PostCOVID-19Symptoms | NumberofSubjectsamplestested | WELLlife™COVID-19 /InfluenzaA&B TestPositives | ComparatorPositives | % PositiveRate (byComparator) | PPA (95%CI) |
|---|---|---|---|---|---|
| Day 0 | 39 | 3 | 5 | 12.80% | 60.0%(23.1%, 88.2%) |
| Day 1 | 168 | 26 | 28 | 16.70% | 92.9%(77.4%, 98.0%) |
| Day 2 | 236 | 30 | 36 | 15.25% | 83.3%(68.1%, 92.1%) |
| Day 3 | 156 | 27 | 27 | 17.30% | 96.3%(81.7%, 99.3%) |
| Day 4 | 106 | 16 | 19 | 17.90% | 84.2%(62.4%, 94.5%) |
| Total | 705 | 101 | 115 | 16.31% | 87.8%(80.6%, 92.6%) |
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INFLUENZA A PERFORMANCE
Table 13: WELLlife™ COVID-19 / Influenza A&B Home Test performance compared to reference PCR: Influenza A
| Influenza A | ComparatorPositives | ComparatorNegatives | Total |
|---|---|---|---|
| Candidate Positives | 75 | 2 | 77 |
| Candidate Negatives | 11 | 617 | 628 |
| Total | 86 | 619 | 705 |
| Positive Percent Agreement (PPA) = 87.2% (75/86) 95% CI: 78.5% - 92.7% | |||
| Negative Percent Agreement (NPA) = 99.7% (617/619) 95% CI: 98.8% - 99.9% |
INFLUENZA B PERFORMANCE
Table 14: WELLlife™ COVID-19 / Influenza A&B Home Test performance compared to reference PCR: Influenza B
| Influenza B | ComparatorPositives | ComparatorNegatives | Total |
|---|---|---|---|
| Candidate Positives | 29 | 2 | 31 |
| Candidate Negatives | 4 | 670 | 674 |
| Total | 33 | 672 | 705 |
| Positive Percent Agreement (PPA) = 87.9% (29/33) 95% CI: 72.7% - 95.2% | |||
| Negative Percent Agreement (NPA) = 99.7% (670/672) 95% CI: 98.9% - 99.9% |
7 Conclusion
The information provided in this Premarket Notification [510(k)] demonstrates that the performance of the WELLlife™ COVID-19 / Influenza A&B Home Test and WELLlife™ COVID-19 / Influenza A&B Antigen Test are substantially equivalent in intended use, technological characteristics and performance to the predicate device.
N/A