(93 days)
Not Found
No
The device description clearly states it is a lateral flow immunoassay, which is a traditional diagnostic technology that does not utilize AI or ML. The summary does not mention any software, algorithms, or computational analysis that would indicate the presence of AI/ML.
No.
This device is an in vitro diagnostic (IVD) test intended for the qualitative detection and differentiation of specific antigens (SARS-CoV-2, influenza A, and influenza B) to identify the presence of these viruses. It does not treat, prevent, or cure any disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the qualitative detection and differentiation of influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen," directly indicating its purpose in identifying disease markers. Furthermore, the "Device Description" section confirms its function as a "lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens," and explicitly labels it as being "for in vitro diagnostic use only."
No
The device is a lateral flow immunoassay, which is a physical test kit containing a test strip and plastic housing. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The text explicitly states: "The device is for in vitro diagnostic use only."
Furthermore, the entire description aligns with the definition of an IVD: it's a test performed on a biological sample (anterior nasal swab) outside of the body (in vitro) to detect specific substances (antigens from SARS-CoV-2, influenza A, and influenza B) to aid in the diagnosis of a condition (respiratory tract infection).
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
SCA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior nasal swab samples
Indicated Patient Age Range
individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.
Intended User / Care Setting
Home Use (nonprescription) / Over-The-Counter Use; Professional Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A prospective study was performed in which 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 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance:
A prospective clinical study was performed with 705 evaluable subjects.
- SARS-CoV-2 Performance:
- Positive Percent Agreement (PPA) = 87.8% (101/115) with 95% CI: 80.6% - 92.6%
- Negative Percent Agreement (NPA) = 99.8% (589/590) with 95% CI: 99.1% - 100%
- Performance stratified by Days Post Symptoms Onset for SARS-CoV-2:
- Day 0: PPA = 60.0% (23.1%, 88.2%)
- Day 1: PPA = 92.9% (77.4%, 98.0%)
- Day 2: PPA = 83.3% (68.1%, 92.1%)
- Day 3: PPA = 96.3% (81.7%, 99.3%)
- Day 4: PPA = 84.2% (62.4%, 94.5%)
- Influenza A Performance:
- Positive Percent Agreement (PPA) = 87.2% (75/86) with 95% CI: 78.5% - 92.7%
- Negative Percent Agreement (NPA) = 99.7% (617/619) with 95% CI: 98.8% - 99.9%
- Influenza B Performance:
- Positive Percent Agreement (PPA) = 87.9% (29/33) with 95% CI: 72.7% - 95.2%
- Negative Percent Agreement (NPA) = 99.7% (670/672) with 95% CI: 98.9% - 99.9%
Non-clinical Performance:
- Lot-to-Lot Precision: A single-site study was conducted using three levels of contrived samples (negative, 2x LoD co-spike, 5x LoD co-spike) across 3 lots, 2 operators, and 10 days (120 results per sample type). All agreements with expected results were 100% for negative, 2x LoD, and 5x LoD samples. A supplemental precision study (with samples spiked with
N/A
0
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 Test
WELLlife 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"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
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
3
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.
4
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5
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 Way |
| San Diego, CA, 92121 | |
| Contact Person | Kaiyu Xiao |
| Senior Regulatory Affairs Manager | |
| Tel: +86-15005196892 | |
| E-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 |
6
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
7
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. | |
| Intended | ||
| Use/ | ||
| Indications | ||
| for Use | The Healgen Rapid Check | |
| COVID-19/Flu 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 | ||
| non-prescription home use by | ||
| individuals aged 14 years or | ||
| older testing themselves, or | 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. | ||
| 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 ruleSARS-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. | 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 WELLlifeTM 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.
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. |
| Regulation
Number | 21 CFR 866.3987 | Same |
| Disease
Population | Respiratory tract infection | Same |
| Intended
users / User
Environment | OTC Lay User | Same |
| Test
Principle | Lateral flow immunoassay | Same |
| Sample type | Anterior nasal swab
specimens | Same |
| Assay
targets | SARS-CoV-2 nucleocapsid
protein antigens
Nucleoprotein antigen from
influenza A virus
Nucleoprotein antigen from
influenza B virus | Same |
| Assay Type | Qualitative | Same |
Table 1: Comparison with Predicate Device
8
9
| Wondfo USA Co., Ltd. | 510(k) Summary |
|---|---|
| WELLife TM COVID-19 / Influenza A&B Test |
| Mode of
| Results | Visual | Same |
|---|---|---|
| Assay | ||
| Control | Internal procedural control | Same |
| Storage | ||
| Temperature | 2°C to 30°C | Same |
| Differences | ||
| Time to | ||
| Result | 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.
10
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%) | 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/Prefer | |||||||||||||||||||||||||||||||
| not | |||||||||||||||||||||||||||||||
| to | |||||||||||||||||||||||||||||||
| answer | 0 | 15 (2.8%) | 15 (2.1%) | ||||||||||||||||||||||||||||
| Race | |||||||||||||||||||||||||||||||
| American Indian or Alaskan | |||||||||||||||||||||||||||||||
| Native | 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 Other | |||||||||||||||||||||||||||||||
| Pacific Islander | 0 | 0 | 0 | ||||||||||||||||||||||||||||
| More than one race | 1 (0.6%) | 5 (0.9%) | 6 (0.9%) |
20
WELLlife™ COVID-19 / Influenza A&B Test
| Characteristic | Lay-user/ Tester
Collection
N=160 | Self-Collecting
N=545 | Overall
N=705 |
|---------------------------------|-----------------------------------------|--------------------------|------------------|
| Unknown/Prefer not to
answer | 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 | Comparator
Positives | Comparator
Negatives | 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 Post
COVID-
19
Symptoms | Number
of
Subject
samples
tested | WELLlife™
COVID-19 /
Influenza
A&B Test
Positives | Comparator
Positives | % Positive
Rate (by
Comparator) | 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%) |
21
INFLUENZA A PERFORMANCE
Table 13: WELLlife™ COVID-19 / Influenza A&B Home Test performance compared to reference PCR: Influenza A
| Influenza A | Comparator
Positives | Comparator
Negatives | 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 | Comparator
Positives | Comparator
Negatives | 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.