(90 days)
K231795, QuickVue COVID-19 Test
Not Found
No
The device description and intended use clearly describe a visually read lateral flow immunoassay. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The results are interpreted visually by the user.
No
This device is for rapid, qualitative detection of SARS-CoV-2 antigens for diagnostic purposes, and the text explicitly states it should not be used to determine any treatments or as a substitute for visits to a healthcare provider.
Yes
The device is a diagnostic device because its "Intended Use / Indications for Use" states that it is for the "rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens," which directly tests for the presence of a disease.
No
The device description clearly outlines a physical immunochromatographic membrane assay with a test strip and a cardboard test card. The results are interpreted visually based on the presence of colored lines, indicating a hardware-based test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens". This involves testing a biological sample (nasal swab) in vitro (outside the body) to diagnose a condition (COVID-19).
- Device Description: The description details an "immunochromatographic membrane assay" that uses antibodies to detect antigens in a nasal swab specimen. This is a common method used in IVD tests.
- Performance Studies: The document describes analytical and clinical studies conducted to evaluate the performance of the device using biological samples and comparing results to a reference method (RT-PCR). This is standard practice for demonstrating the effectiveness of an IVD.
- Key Metrics: The document provides key performance metrics like Positive Agreement (Sensitivity) and Negative Agreement (Specificity), which are crucial for evaluating the accuracy of an IVD.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device fits that definition perfectly.
N/A
Intended Use / Indications for Use
The BinaxNOW COVID-19 Antigen Self Test is a visually read lateral flow immunoassay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from November, 2020 to July, 2022, when SARS-CoV-2 Delta and Omicron were dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
Product codes
QYT
Device Description
The BinaxNOW COVID-19 Antigen Self Test is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab specimens. SARS-COV-2 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card.
To perform the test, a nasal swab specimen is collected from the patient, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into ugh the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior nasal (nares)
Indicated Patient Age Range
15 years or older testing themselves, or adults testing individuals aged 2 years or older.
Intended User / Care Setting
non-prescription home 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
- Usability Study: Conducted to assess the lay user's ability to understand the BinaxNOW COVID-19 Antigen Self Test instructions for use and to perform testing using the components provided within the test kit.
- Lay User Readability Study: 30 users across various age ranges and with and without vision impairments participated. Trained personnel tested devices by running samples at specified concentrations, as well as negative, invalid, and strong positive controls. Participants interpreted results visually.
- Clinical Studies: Two prospective studies were conducted in the United States.
- First study: 5 investigational sites (November 2020 - March 2021). Subjects either self-collected one nasal swab or had one collected by another individual and performed the BinaxNOW COVID-19 Antigen Self Test. A matched anterior nasal swab sample was taken by a healthcare professional for testing on an FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assay as the comparator; collected after the BinaxNOW swab.
- Second study (Omicron Study): High-volume COVID community testing site (March 2022 - July 2022), led by Johns Hopkins Medicine in collaboration with the University of Maryland Medical Center and Maryland Department of Health. Participants independently performed the BinaxNOW COVID-19 Antigen Self Test. A matched anterior nasal swab sample was taken by a healthcare professional for testing on an FDA Emergency Use Authorized real-time Polymerase Chain Reaction (RT-PCR) assay as the comparator; collected prior to the BinaxNOW swab.
- Overall/Combined Clinical Studies: A total of 604 nasal swabs from symptomatic patients (within 5 days of symptom onset) suspected of COVID-19.
- Serial Testing Study: Prospective clinical study (January 2021 - May 2022) as part of the RADx initiative.
- Sample size: 7,361 individuals enrolled, 5,600 eligible for analysis. 154 tested positive for SARS-CoV-2 infection based on RT-PCR.
- Data Source: Decentralized clinical study with broad geographical representation of the United States.
- Annotation Protocol: Participants were asymptomatic upon enrollment and for at least 14 days prior, with no SARS-CoV-2 infection in the three months prior. Participants conducted serial testing (every 48 hours) for 15 days using one of three EUA authorized SARS-CoV-2 OTC rapid antigen tests. If an antigen test was positive, the result was considered positive. At each antigen testing time point, subjects also collected a nasal swab for comparator testing using a home collection kit (15-minute normalization window between swabs). SARS-CoV-2 infection status was determined by a composite comparator method (at least two highly sensitive EUA RT-PCRs; if discordant, a third was performed, and the final result was based on majority rule). Symptom status was reported via MyDataHelps app.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
-
Precision Study:
- Study Type: Evaluated total variability across testing days, operators, and test device lots.
- Sample Size: 135 observations per panel member (3 operators x 3 lots x 3 replicates/panel member).
- Key Results:
- Percent Agreement with Expected Results (95% Confidence Interval) for Lot 1: 5X LoD 100% (44/44), 1X LoD 100% (42/42), High Negative 100% (47/47), Negative 100% (46/46).
- Lot 2: 5X LoD 100% (43/43), 1X LoD 97.8% (44/45), High Negative 100% (44/44), Negative 100% (47/47).
- Lot 3: 5X LoD 100% (47/47), 1X LoD 95.8% (46/48), High Negative 100% (43/43), Negative 100% (41/41).
-
Analytical Sensitivity (Limit of Detection) Study:
- Study Type: Determined the lowest detectable concentration of SARS-CoV-2 virus strains.
- Key Results: LoD confirmed as 3.5 x 10^3 TCID50/mL for USA-WA1/2020 and 1.6 x 10^3 TCID50/mL for B.1.1.529 (Omicron) in natural nasal swab matrix. This equates to 70 TCID50/swab for USA-WA1/2020 and 32.06 TCID50/swab for B.1.1.529 (Omicron).
- International Standard for SARS-CoV-2 Ag (NIBSC 21/368) LoD: Preliminary LoD was 500 IU/mL (3/3 detected). Confirmatory LoD was 375 IU/mL (20/20 detected).
-
Analytical Reactivity (Inclusivity) Study:
- Study Type: Determined the ability to detect various SARS-CoV-2 strains.
- Sample Size: n=5 replicates per virus strain.
- Key Results: Detected all tested strains at specified concentrations, including Alpha, Beta, Delta, Gamma, Iota, Italy-INMI1, Kappa, Zeta, and various Omicron sublineages (BA.2.3, BA.2.12.1, BA.2.75.5, BA.4.6, BA.5, BA.5.5, BF.5, BF.7, BQ.1, BQ.1.1, XBB, JN.1).
-
Analytical Specificity (Cross Reactivity) and Microbial Interference Study:
- Study Type: Evaluated cross-reactivity and interference from commensal and pathogenic microorganisms.
- Sample Size: 29 panel members (9 bacteria, 17 viruses, 1 yeast, pooled human nasal wash). Each tested n=5 in the absence or presence of inactivated SARS-CoV-2 virus at 3xLoD.
- Key Results: No cross-reactivity or interference observed for tested microorganisms at 1 x 10^6 CFU/mL for bacteria and yeast and at 1 x 10^5 TCID50/mL for viruses.
-
High Dose Hook Effect Study:
- Study Type: Tested for high dose hook effect.
- Key Results: No high dose hook effect observed up to 1.4 x 10^6 TCID50/mL of inactivated SARS-CoV-2 virus.
-
Interfering Substances Study:
- Study Type: Evaluated effect of various substances found in respiratory specimens or artificially introduced.
- Key Results: No adverse effect on test performance found for 24 listed substances (e.g., throat lozenges, nasal sprays, blood, mucin, common drugs) at specified concentrations.
-
Usability Study:
- Study Type: Assessed lay user's ability to understand instructions and perform testing.
- Key Results: 98% correct execution of procedural steps. 100% of participants produced a valid result and interpreted their test result correctly.
-
Lay User Readability Study:
- Study Type: Determined whether lay users can adequately interpret devices with varying signal strengths.
- Sample Size: 30 users.
- Key Results: Overall 100% correct interpretation for strong positive control, 83% for Positive 2xLoD, 67% for Positive 1.5xLoD, 60% for Positive
N/A
0
February 11, 2025
Image /page/0/Picture/1 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Abbott Diagnostics Scarborough, Inc. Kristen Cyr Regulatory Affairs Specialist 10 Southgate Road Scarborough, Maine 04074
Re: K243518
Trade/Device Name: BinaxNOW COVID-19 Antigen Self Test; BinaxNOW COVID-19 Ag Card Regulation Number: 21 CFR 866.3984 Regulation Name: Over-The-Counter Test To Detect SARS-Cov-2 From Clinical Specimens Regulatory Class: Class II Product Code: QYT Dated: November 12, 2024 Received: November 13, 2024
Dear Kristen Cyr:
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).
2
Sincerely,
Digitally signed by Silke Silke Schlottmann -S Schlottmann -S Date: 2025.02.11 16:01:26
-05'00'
Silke Schlottman, 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) K243518
Device Name BinaxNOW COVID-19 Antigen Self Test
Indications for Use (Describe)
The BinaxNOW COVID-19 Antigen Self Test is a visually read lateral flow immunoassay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from November, 2020 to July, 2022, when SARS-CoV-2 Delta and Omicron were dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Preparation Date: February 10, 2025
CONTACT DETAILS
Applicant Name: Abbott Diagnostics Scarborough, Inc. Applicant Address: 10 Southgate Road, Scarborough, Maine 04074 USA Applicant Contact: Ms. Kristen Cyr Applicant Contact Email : kristen.cyr@abbott.com Applicant Contact Phone : (207) 210-4311
DEVICE NAME
Device Trade Name: BinaxNOW COVID-19 Antigen Self Test Common Name: BinaxNOW COVID-19 Self Test; BinaxNOW COVID-19 Classification Name: Over-The-Counter Covid-19 Antigen Test Regulation Number: 866.3984 Product Code: QYT
PREDICATE DEVICE
K231795, QuickVue COVID-19 Test
DEVICE DESCRIPTION SUMMARY
The BinaxNOW COVID-19 Antigen Self Test is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect SARS-CoV-2 nucleocapsid protein from nasal swab specimens. SARS-COV-2 specific antibodies and a control antibody are immobilized onto a membrane support as two distinct lines and combined with other reagents/pads to construct a test strip. This test strip and a well to hold the swab specimen are mounted on opposite sides of a cardboard, book-shaped hinged test card.
To perform the test, a nasal swab specimen is collected from the patient, 6 drops of extraction reagent from a dropper bottle are added to the top hole of the swab well. The patient sample is inserted into ugh the bottom hole of the swab well, and firmly pushed upwards until the swab tip is visible through the top hole. The swab is rotated 3 times clockwise and is closed, bringing the extracted sample into contact with the test strip. Test results are interpreted visually at 15 minutes based on the presence of visually detectable pink/purple colored lines. Results should not be read after 30 minutes.
INTENDED USE/INDICATIONS FOR USE
The BinaxNOW COVID-19 Antigen Self Test is a visually read lateral flow immunoassay intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal (nares) swab specimens from individuals with signs and symptoms of COVID-19. This test is for non-prescription home use by individuals aged 15 years or older testing themselves, or adults testing individuals aged 2 years or older.
All negative results are presumptive. Symptomatic individuals with an initial negative test result must be retested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment.
Positive results do not rule out co-infection with other respiratory pathogens.
5
510(K) SUMMARY
This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider.
The performance characteristics for SARS-CoV-2 were established from November, 2020 to July, 2022, when SARS-CoV-2 Delta and Omicron were dominant. Test accuracy may change as new SARS-CoV-2 viruses emerge. Additional testing with a lab-based molecular test (e.g., PCR) should be considered in situations where a new virus or variant is suspected.
INDICATIONS FOR USE COMPARISON
The BinaxNOW COVID-19 Antigen Self Test and the predicate device, QuickVue COVID-19 Test (K231795), have the same intended use. The test systems are intended for the rapid, qualitative detection of SARS-CoV-2 directly in anterior nasal swab specimens as an aid in the diagnosis of SARS-CoV-2 infection.
TECHNOLOGICAL COMPARISON
The BinaxNOW Antigen Self Test (BinaxNOW COVID-19 Ag Card) and the predicate device, QuickVue COVID-19 Test, have the same technological characteristics. Both test systems are visually read lateral flow immunoassays for detection of the nucleocapsid protein antigen from SARS-CoV-2 in clinical specimens.
NON-CLINICAL AND/OR CLINICAL TESTS SUMMARY AND CONCLUSIONS ANALYTICAL STUDIES
Precision
A precision study was performed to assess the total variability of the BinaxNOW COVID-19 Antigen Self Test across testing days, operators and BinaxNOW COVID-19 Antigen Self Test device lots. The testing panel was prepared using inactivated SARS-CoV-2 (isolate USA-WA1/2020) diluted into clinical nasal matrix and then spiked onto nasal swabs. The testing panel consisted of four members: (1) Negative (no analyte); (2) 0.05X LoD; (3) 1X LoD; and (4) 5X LoD. Each test panel was tested by three Operators across five non-consecutive days, each running three replicates per day (3 operators x 3 lots x 3 replicates/panel member) for a total of 135 observations per panel member. The results are presented in the table below.
Precision Study Results
| Device
Lot | Sample | Percent Agreement with Expected
Results (95% Confidence Interval |
|---------------|----------------|---------------------------------------------------------------------|
| Lot
1 | 5X LoD | 100% (44/44) (92.0-100.0%) |
| | 1X LoD | 100% (42/42) (91.6-100.0%) |
| | High Negative* | 100% (47/47) (92.4-100.0%) |
| | Negative | 100% (46/46) (92.3-100.0%) |
| Lot
2 | 5X LoD | 100% (43/43) (91.8-100.0%) |
| | 1X LoD | 97.8% (44/45) (88.4-99.6%) |
| | High Negative* | 100% (44/44) (92.0-100.0%) |
| | Negative | 100% (47/47) (92.4-100.0%) |
| Lot
3 | 5X LoD | 100% (47/47) (92.4-100.0%) |
| | 1X LoD | 95.8% (46/48) (86.0-98.8%) |
| | High Negative* | 100% (43/43) (91.8-100.0%) |
6
| Negative | 100% (41/41) (91.4-100.0%) | |
|---|---|---|
| *Sample prepared to a concentration 0.05X LOD |
*Sample prepared to a concentration 0.05X LOD
Analytical Sensitivity (Limit of Detection)
BinaxNOW COVID-19 Antigen Self Test limit of detection (LoD) was determined by evaluating different concentrations of two inactivated strains of SARS-CoV-2 virus. Presumed negative natural nasal swab specimens were eluted in PBS. Swab eluates were combined and mixed thoroughly to create a clinical matrix pool to be used as the diluent. Inactivated SARS-COV-2 virus was diluted in this natural nasal swab matrix pool to generate virus dilutions for testing.
Contrived nasal swab samples were prepared by absorbing 20 microliters of each virus dilution onto the swab. The contrived swab samples were tested according to the test procedure.
For each strain, the LoD was determined as the lowest virus concentration that was detected ≥ 95% of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive).
The BinaxNOW COVID-19 Antigen Self Test LoD in natural nasal swab matrix was confirmed as 3.5 x 103TCID50/mL for USA-WA1/2020 and 1.6 x 103 TCID50/mL for B.1.1.529 (Omicron). Based upon the testing procedure for this study this LoD equates to 70 TCID50/swab for USA-WA1/2020 and 32.06 TCID50/8wab for B.1.1.529 (Omicron).
Limit of Detection Study Results
| Strain | Concentration
TCID50/mL |
|---------------------|----------------------------|
| USA-WA1/2020 | $3.5 \times 10^3$ |
| B.1.1.529 (Omicron) | $1.6 \times 10^3$ |
Testing with International Standard for SARS-CoV-2 Ag (NIBSC 21/368)
A study was performed to also determine the LoD for the BinaxNOW COVID-19 Antigen Self Test in nasal samples using the International Standard for SARS-CoV-2 antigen as a standardized material.
As per the International Standard instructions, the international standard material was reconstituted in 0.25 mL of ultra-pure water. Following reconstitution, the ampule was left at ambient temperature for 20 minutes and then mixed thoroughly, avoiding generation of excess foam. The reconstitution of the material yielded a final stock concentration equal to 2.0 x 104 IU/mL.
For each replicate, 20 uL of virus dilution was applied to a swab and the swab was tested according to the IFU. A preliminary LoD concentration was determined by testing a series of 2-fold dilutions of the antigen spiked into natural nasal swab matrix in replicates of three (3). The lowest concentration with 3 out of 3 positive replicates was considered to be the preliminary LoD. The results of the preliminary LoD study are shown in the Table below:
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| Concentration
(IU/ml) | BinaxNOW COVID-19 Ag
Card Results | |
|--------------------------|--------------------------------------|------------|
| | # Detected | % Detected |
| 2000 | 3/3 | 100 |
| 1000 | 3/3 | 100 |
| 500 | 3/3 | 100 |
| 250 | 0/3 | 0 |
| 125 | 0/3 | 0 |
International Standard for SARS-CoV-2 Ag LoD Range Finding Results
The preliminary LoD was confirmed by testing an additional seventeen (17) replicates per dilution for a total of (20) until less than 100% positive results were obtained. The results of this testing, as shown in the table below confirmed the LoD for the International Standard Antigen to be 375 IU/mL (7.5 IU/swab).
International Standard for SARS-CoV-2 Ag Confirmatory LoD Results
| Concentration
(IU/mL) | BinaxNOW COVID-19 Ag
Card Results | |
|--------------------------|--------------------------------------|------------|
| | # Detected | % Detected |
| 500 | 20/20 | 100 |
| 375 | 20/20 | 100 |
| 250 | 4/20 | 20 |
Analytical Reactivity (Inclusivity)
An Analytical Reactivity (Inclusivity) study was performed to determine whether the BinaxNOW COVID-19 Antigen Self Test is able to detect a variety of SARS-CoV-2 strains.
Vendor provided stocks of SARS-CoV-2 strains were diluted in natural nasal swab matrix to generate virus dilutions for testing. Contrived swab samples were prepared by coating 20 microliters of virus dilution onto each swab.
Each dilution of virus strain was tested n = 5 replicates. A concentration level was considered "reactive" in this study if all five replicates generated a positive result.
The BinaxNOW COVID-19 Antigen Self Test detected all strains tested at the concentrations indicated in the table below:
Analytical Reactivity Study Results
| Variant | Concentration
(TCID50/ml) |
|-------------------|------------------------------|
| Alpha (B.1.1.7) | $2.80 x 10^5$ |
| Beta (B.1.351) | $5.60 x 10^4$ |
| Delta (B.1.617.2) | $1.40 x 10^4$ |
| Gamma (P.1) | $1.40 x 10^4$ |
| Iota (B.1.526) | $5.60 x 10^4$ |
| Italy-INMI1 | $2.80 x 10^5$ |
| Kappa (B.1.617.1) | $8.40 x 10^4$ |
| Zeta (P.2) | $2.80 x 10^4$ |
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| Variant | Concentration
(TCID50/ml) |
|---------------------|------------------------------|
| Omicron (BA.2.3) | $2.10 x 10^4$ |
| Omicron (BA.2.12.1) | $1.05 x 10^4$ |
| Omicron (BA.2.75.5) | $7.00 x 10^3$ |
| Omicron (BA.4.6) | $2.80 x 10^4$ |
| Omicron (BA.5) | $4.48 x 10^5$ |
| Omicron (BA.5.5) | $8.80 x 10^2$ |
| Omicron (BF.5) | $2.80 x 10^4$ |
| Omicron (BF.7) | $1.12 x 10^5$ |
| Omicron (BQ.1) | $5.60 x 10^4$ |
| Omicron (BQ.1.1) | $7.00 x 10^3$ |
| Omicron (XBB) | $2.24 x 10^5$ |
| Omicron (JN.1) | $2.90 x 10^3$
(IFU/mL) |
Analytical Specificity (Cross Reactivity) and Microbial Interference
Cross reactivity and potential interference of BinaxNOW COVID-19 Antigen Self Test was evaluated by testing 29 commensal and pathogenic microorganisms (9 bacteria, 17 viruses, 1 yeast and pooled human nasal wash) that may be present in the nasal cavity. Each organism, virus, and yeast was tested n=5 in the absence or presence of inactivated SARS-CoV-2 virus at 3xLoD (210 TCID50/swab). No cross-reactivity or interference was seen with the microorganisms in the table below when tested at 1 x 106 CFU/mL for bacteria and yeast and at 1 x 105 TCID50/mL for viruses.
| Type | Panel Member |
|---|---|
| Viruses | Human Adenovirus 1 |
| Human Coronavirus 229E | |
| Human Coronavirus NL63 | |
| Human Coronavirus OC43 | |
| Human Coronavirus HKU1* | |
| Enterovirus 70 | |
| Human Metapneumovirus (hMPV) | |
| Human Parainfluenza virus 1 | |
| Human Parainfluenza virus 2 | |
| Human Parainfluenza virus 3 | |
| Human Parainfluenza virus 4 | |
| RSV A | |
| Rhinovirus 1A | |
| MERS-coronavirus | |
| Human Influenza A/California/07/09 | |
| Human Influenza A/New | |
| Caledonia/20/99 | |
| Human Influenza A/Brisbane/02/18 | |
| Human Influenza B/Wisconsin/1/10 | |
| Bacteria | Bordetella pertussis |
| Chlamydia pneumoniae | |
| Haemophilus influenzae | |
| Legionella pneumophila | |
| Mycoplasma pneumoniae |
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| Type | Panel Member |
|---|---|
| Staphylococcus aureus | |
| Staphylococcus epidermidis | |
| Streptococcus pneumoniae | |
| Streptococcus pyogenes | |
| Yeast | Candida albicans |
| Other | Pooled Human Nasal Wash |
*Four (4) unique clinical specimens were evaluated with Ct counts ranging from 22.3 – 32.0
High Dose Hook Effect
No high dose hook effect was observed when tested with up to a concentration of 1.4 x 106 TCID50/mL of inactivated SARS-CoV-2 virus with the BinaxNOW COVID-19 Antigen Self Test.
Interfering Substances
The following substances, naturally present in respiratory specimens or that may be artificially introduced into the upper respiratory tract, were evaluated with the BinaxNOW COVID-19 Antigen Self Test at the concentrations listed below and were found not to affect test performance.
| Substance | Active Ingredient | Concentration |
|---|---|---|
| Throat Lozenge | Menthol, Benzocaine | 3 mg/mL |
| Sore Throat Spray | Phenol | 5% w/v |
| OTC Nasal Spray 1 | Mometasone Furoate | 15% v/v |
| OTC Nasal Spray 2 | Triamcinolone | 15% v/v |
| OTC Nasal Spray 3 | Budesonide | 15% v/v |
| OTC Nasal Spray 4 | Fluticasone | 15% v/v |
| OTC nasal gel | Sodium Chloride with | |
| Preservatives | 15% v/v | |
| OTC Nasal Spray 5 | Phenylephrine | 15% v/v |
| OTC Nasal Spray 6 | Oxymetazoline | 15% v/v |
| OTC Nasal Spray 7 | Cromolyn | 15% v/v |
| OTC Homeopathic Nasal | ||
| Spray | Zicam (Galphimia glauca, | |
| Histaminum hydrochloricum, | ||
| Luffa operculate, sulfur) | 15% v/v | |
| OTC Homeopathic Nasal | ||
| Wash | Alkalol | 15% v/v |
| Hand Sanitizer | Ethyl Alcohol 62% | 1% w/v |
| Hand Soap | Ethyl Alcohol 62% | 1% w/v |
| Endogenous | Whole Blood | 2.5% v/v |
| Endogenous | Mucin | 2.5 mg/mL |
| Endogenous | Leukocytes | $5 x 10^6$ cells/mL |
| Antibiotic, Nasal | ||
| Ointment | Mupirocin | 10 mg/mL |
| Nasal Corticosteroid 1 | Beclomethasone | 15% v/v |
10
| Substance | Active Ingredient | Concentration |
|---|---|---|
| Nasal Corticosteroid 2 | Dexamethasone | 15% v/v |
| Nasal Corticosteroid 3 | Flunisolide | 15% v/v |
| Anti-Viral Drug 1 | Tamiflu (Oseltamivir | |
| Phosphate) | 5 mg/mL | |
| Anti-Viral Drug 2 | Remdesivir | 5 mg/mL |
| Anti-Viral Drug 3 | Molnupiravir | 5 mg/mL |
| Antibiotic | Tobramycin | 1.44 mg/mL |
| Anti-Viral Drug | Zanamivir | 281.5 ng/mL |
Usability Study
A usability study was conducted to assess the lay user's ability to understand the BinaxNOW COVID-19 Antigen Self Test instructions for use and to perform testing using the components provided within the test kit.
The results of the usability testing demonstrated that the users sufficiently comprehend the test procedure as described in the IFU and indicated that the occurrence of user-related errors is low (98% correct execution of procedural steps). Additionally, the usability study showed that the effect of errors was low (100% of participants produced a valid result and interpreted their test result correctly).
Lay User Readability Study
The purpose of this study was to determine whether lay users can adequately interpret BinaxNOW COVID-19 Antigen Self Test devices with varying signal strengths. Trained personnel test devices by running samples at the following concentrations of SARS-COV-2 recombinant antigen: 2X LoD and ≤1X LoD. Additionally, negative devices (no SARS-CoV-antigen), devices with various types of invalid results, and devices run with a strong positive control were prepared. A total of 30 users across various age ranges and with and without vision impairments participated in the study.
A summary of the results of the study is shown in the Table below by age and visual condition. Overall, the study demonstrated that lay user participants can correctly perceive and interpret the test card results when sample lines are clear. When sample lines are faint, the accuracy decreases as detectability diminishes. In this study, this effect appeared to be influenced by age and visual capabilities of the person reading the results. It is therefore recommended that users with conditions affecting their vision are encouraged to seek assistance to interpret results accurately. A related warning statement is included in the IFU.
| Summary of Results by Visual Condition (Correct Interpretations) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Visual Condition | Positive Control | Positive 2xLoD | Positive 1.5xLoD | Positive ≤1xLoD | Negative Control | Invalid 1 | Invalid 2 | Invalid 3 | Invalid 4 |
| Good (n=10) | 10/10 (100%) | 10/10 (100%) | 8/10 (80%) | 9/10 (90%) | 10/10 (100%) | 9/10 (90%) | 9/10 (90%) | 10/10 (100%) | 10/10 (100%) |
| Other* (n=20) | 20/20 (100%) | 15/20 (75%) | 12/20 (60%) | 9/20 (45%) | (19/20) (95%) | 20/20 (100%) | 20/20 (100%) | 20/20 (100%) | 19/20 (95%) |
| Overall (n=30) | 30/30 (100%) | 25/30 (83%) | 20/30 (67%) | 18/30 (60%) | 29/30 (97%) | 29/30 (97%) | 29/30 (97%) | 30/30 (100%) | 29/30 (97%) |
Summary of Results by Visual Condition (Correct Interpretations)
*Far/near-sighted or wear bifocals
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| Summary of Results by Age (Correct Interpretations) | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Visual | |||||||||
| Condition | Positive | ||||||||
| Control | Positive | ||||||||
| 2xLoD | Positive | ||||||||
| 1.5xLoD | Positive | ||||||||
| Total | 214 | 390 | 604 | ||||||
| Positive Agreement: 186/214 86.9% (95% CI: 81.7, 90.8) | |||||||||
| Negative Agreement: 384/390 98.5% (95% CI: 96.7, 99.3) |
Note: Five (5)samples generated an invalid BinaxNOW COVID-19 Ag Card result and are not included in the analysis. The invalid rate is 5/730, or 0.68% (95% CI from 0.29% to 1.50%). The denominator for the invalid rate is based on total study enrollment.
BinaxNOW COVID-19 Antigen Self Test Performance within 5 days of symptom onset against the Comparator Method - Original Study (November 2020 - March 2021)
| BinaxNOW COVID-19
| Antigen Self Test | Comparator Method | ||
|---|---|---|---|
| Positive | Negative | Total | |
| Positive | 71 | 3 | 74 |
| Negative | 16 | 205 | 221 |
| Total | 87 | 208 | 295 |
| Positive Agreement: 71/87 | 81.6% (95% CI: 72.2, 88.4) | ||
| Negative Agreement: 205/208 | 98.6% (95% CI: 95.8, 99.5) | ||
| Overall Agreement: 93.6% (95% CI: 90.2, 95.8) |
Note: Three (3) samples generated an invalid BinaxNOW COVID-19 Antigen Self Test result and are not included in the analysis. The invalid rate is 3/397, or 0.76% (95% CI from 0.26% to 2.20%). The denominator for the invalid rate is based on total study enrollment.
BinaxNOW COVID-19 Antigen Self Test Performance within 5 days of symptom onset against the Comparator Method - Omicron Study (February 2022 - July 2022)
| BinaxNOW COVID-19
| Antigen Self Test | Comparator Method | ||
|---|---|---|---|
| Positive | Negative | Total | |
| Positive | 115 | 3 | 118 |
| Negative | 12 | 179 | 191 |
| Total | 127 | 182 | 309 |
| Positive Agreement: 115/127 | 90.6% (95% CI: 84.2, 94.5) | ||
| Negative Agreement: 179/182 | 98.4% (95% CI: 95.3, 99.4) |
Note: Two (2) samples generated an invalid BinaxNOW COVID-19 Antigen Self Test result and are not included in the analysis. The invalid rate is 2/327, or 0.61% (95% CI from 0.17% to 2.20%). The denominator for the invalid rate is based on total study enrollment.
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| DPSO | PPA - Original Study
(November 2020-March 2021) | PPA - Omicron Study
(February 2022-July 2022) |
|-------|----------------------------------------------------|--------------------------------------------------|
| Day 0 | N/A (0/0) | 69.23% (9/13) |
| Day 1 | 94.12% (16/17) | 88.24% (45/51) |
| Day 2 | 73.33% (22/30) | 97.22% (35/36) |
| Day 3 | 76.00% (19/25) | 100.00% (20/20) |
| Day 4 | 88.89% (8/9) | 66.67% (2/3) |
| Day 5 | 100.00% (6/6) | 100.00% (4/4) |
BinaxNOW COVID-19 Antigen Self Test Positive Agreement (PPA) against the Comparator Method - Stratified by Days Post Symptom Onset (DPSO)
Serial Testing
A prospective clinical study was conducted between January 2021 and May 2022 as a component of the Rapid Acceleration of Diagnostics (RADx) initiative from the National Institutes of Health (NIH). A total of 7,361 individuals were enrolled via a decentralized clinical study design, with a broad geographical representation of the United States. Per inclusion criteria, all individuals were asymptomatic upon enrollment in the study and at least 14 days prior to it and did not have a SARS-CoV-2 infection in the three months prior to enrollment. Participants were assigned to one of three EUA authorized SARS-CoV-2 OTC rapid antigen tests to conduct serial testing (every 48 hours) for 15 days. If an antigen test was positive, the serial-antigen testing result is considered positive.
At each rapid antigen testing time point, study subjects also collected a nasal swab for comparator testing using a home collection kit (using a 15-minute normalization window between swabs). SARS-CoV-2 infection status was determined by a composite comparator method on the day of the first antigen test, using at least two highly sensitive EUA RT-PCRs. If results of the first two molecular tests were discordant a third highly sensitive EUA RT-PCR test was performed, and the final test result was based upon the majority rule.
Study participants reported symptom status throughout the study using the MyDataHelps app. Two-day serial antigen testing is defined as performing two antigen tests 36 - 48 hours apart. Three-day serial antigen testing is defined as performing three antigen tests over five days with at least 48 hours between each test.
Out of the 7,361 participants enrolled in the study, 5,600 were eligible for analysis. Among eligible participants, 154 tested positive for SARS-CoV-2 infection based on RT-PCR, of which 97 (62%) were asymptomatic on the first day of their infection, whereas 57 (39%) reported symptoms on the first day of infection.
Performance of the antigen test with serial testing in individuals is described in the table below.
14
Data establishing PPA of COVID-19 antigen serial testing compared to the molecular comparator single day testing throughout the course of infection with serial testing. Data is from all antigen tests in study combined.
| Days After
First PCR
Positive Test
Result | Symptomatic
On First Day Of Testing
Ag Positive / PCR Positive
(Antigen Test Performance % PPA) | | |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------|------------------|
| | 1 Test | 2 Tests | 3 Tests |
| | 0 | 34/57
(59.6%) | 47/51
(92.2%) |
| | 2 | 58/62
(93.5%) | 59/60
(98.3%) |
| | 4 | 55/58
(94.8%) | 53/54
(98.1%) |
| | 6 | 27/34
(79.4%) | 26/33
(78.8%) |
| | 8 | 12/17
(70.6%) | 12/17
(70.6%) |
| | 10 | 4/9
(44.4%) | 3/7
(42.9%) |
3 Tests = three (3) tests performed an average of 48 hours apart. The first test performed on the indicated day, the second test performed 48 hours later, and a final test performed 48 hours after the second test.
The data presented in this 510(k) premarket notification demonstrate that the subject device (BinaxNOW COVID-19 Antigen Self Test) is substantially equivalent to the predicate device (QuickVue COVID-19 Test, K231795). The differences in the BinaxNOW COVID-19 Antigen Self Test (proposed device) and the Quidel QuickVue COVID-19 Test (predicate device, K231795) are limited to the Intended Use population (individuals aged 15 years or older vs. individuals aged 14 years or older). This difference does not affect the overall substantial equivalence of the proposed device to the predicate device in terms of the technological similarity, intended use, safety, and effectiveness. Furthermore, the information contained within this notification demonstrates BinaxNOW COVID-19 Antigen Self Test compliance with the special controls applicable to an over-the-counter test to detect SARS-CoV-2 from clinical specimens.
There is no known potential adverse effect to the operator when using this in vitro device according to the BinaxNOW COVID-19 Antigen Self Test package insert.