BinaxNOW™ COVID-19 Antigen Self Test

K243518 · Abbott Diagnostics Scarborough, Inc. · QYT · Feb 11, 2025 · Microbiology

Device Facts

• Record ID: K243518
• Device Name: BinaxNOW™ COVID-19 Antigen Self Test
• Applicant: Abbott Diagnostics Scarborough, Inc.
• Product Code: QYT · Microbiology
• Decision Date: Feb 11, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3984
• Device Class: Class 2
• Attributes: Pediatric

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 the sole basis for treatment. Positive results do not rule out co-infection with other respiratory pathogens. This test is not a substitute for visits to a healthcare provider or appropriate follow-up and should not be used to determine any treatments without provider supervision. Individuals who test negative and experience continued or worsening COVID-19 like symptoms, such as fever, cough and/or shortness of breath, should seek follow up care from their healthcare provider. The performance characteristics for SARS-CoV-2 were established from 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.

Device Story

Lateral flow immunoassay for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen. Input: anterior nasal swab specimen. Operation: swab inserted into hinged cardboard test card containing nitrocellulose membrane with immobilized anti-SARS-CoV-2 and control antibodies; extraction reagent added to elute/lyse sample; sample flows across strip via capillary action. Output: visual pink/purple lines at 15 minutes (Control line + Sample line). Used in home setting by lay users. Results read visually; no instrument required. Positive result indicates presence of SARS-CoV-2 antigen; negative result is presumptive and requires serial testing if symptomatic. Assists in identifying infection status to guide follow-up care.

Clinical Evidence

Two prospective clinical studies (n=604 symptomatic patients) compared device to FDA-authorized RT-PCR. Combined PPA 86.9% (95% CI: 81.7-90.8%); NPA 98.5% (95% CI: 96.7-99.3%). Serial testing study (n=5,600) evaluated performance over 15 days; 3-test serial regimen showed high sensitivity (up to 98.3% PPA). Analytical studies confirmed LoD, inclusivity across variants (Alpha through JN.1), and lack of cross-reactivity/interference with 29 common respiratory pathogens and substances.

Technological Characteristics

Visually read lateral flow immunoassay. Components: cardboard hinged test card, test strip with immobilized SARS-CoV-2 specific antibodies and control antibody, extraction reagent. Principle: immunochromatographic membrane assay. No electronic components or software algorithms.

Indications for Use

Indicated for rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swab specimens from symptomatic individuals. For non-prescription home use by individuals aged 15+ testing themselves, or adults testing individuals aged 2+. Negative results are presumptive; serial testing required for symptomatic individuals.

Regulatory Classification

Identification

For the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen in individuals 2 years and older.

Predicate Devices

• QuickVue COVID-19 Test (K231795)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

ASSAY ONLY

## I Background Information:

A 510(k) Number
K243518

B Applicant
Abbott Diagnostics Scarborough, Inc.

C Proprietary and Established Names
BinaxNOW COVID-19 Antigen Self Test

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QYT | Class II | 21 CFR 866.3984 - Over-The-Counter Test To Detect SARS-Cov-2 From Clinical Specimens | MI - Microbiology |

## II Submission/Device Overview:

A Purpose for Submission:
The purpose of this over-the-counter 510(k) submission is to obtain 510(k) market clearance for the BinaxNOW COVID-19 Antigen Self Test.

B Measurand:
SARS-CoV-2 nucleocapsid protein antigen

C Type of Test:
Lateral flow immunoassay

## III Intended Use/Indications for Use:

A Intended Use(s):
See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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B Indication(s) 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 the sole basis for treatment.

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

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

The performance characteristics for SARS-CoV-2 were established from 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.

C Special Conditions for Use Statement(s):

OTC – Over The Counter

D Special Instrument Requirements:

None

IV Device/System Characteristics:

A Device Description

The BinaxNOW COVID-19 Antigen Self Test is a visually read lateral flow in vitro diagnostic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The test 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 as two distinct lines and, combined with other reagents/pads, comprise the 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. The sample flow across the test strip only starts when the test card is closed and the test strip is brought in direct physical contact with the sample well.

The BinaxNOW COVID-19 Antigen Self Test is comprised of:

- Test Cards: A cardboard, book-shaped hinged test card containing the test strip

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- Extraction Reagent: Bottle containing $<1 \mathrm{~mL}$ of extraction reagent
- Nasal Swabs
- Patient Instructions for Use


## B Principle of Operation

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. The device consists of a nitrocellulose membrane with adsorbed anti-SARS-CoV-2 antibodies for the sample line and adsorbed Chicken antibodies for the control line. Anti-Chicken and anti-SARS-CoV-2 specific antibodies are conjugated to visualizing particles that are dried onto an inert fibrous support referred to as conjugate pad. The conjugate pad and striped membrane are combined to construct the test strip. The test strip and a well to hold the swab specimen are mounted on opposite sides of a hinged, book shaped test device.

To perform the test, a nasal swab specimen is collected from the patient. Extraction reagent (6 drops) is added from a dropper bottle to the swab well and then the swab is inserted into the test card. The swab is rotated 3 times to elute, lyse and homogenize the sample material from the swab. The card is then closed, bringing the extracted sample into contact with the test strip. As the sample flows along the strip, SARS-CoV-2 antigen first binds to a colloidal gold-conjugated anti-SARS-Cov-2 specific antibody and then is captured by immobilized anti-SARS-CoV-2 antibody, resulting in the presence of a visible line. The control line is formed when colloidal gold-conjugated anti-Chicken antibodies are carried along the test strip by the sample and captured by immobilized Chicken antibodies. Test results are read visually at 15 minutes without the use of an instrument.

## C Description of Test Steps

1. Remove test card from pouch. Make sure the blue control line is present in the result window. Open the card and lay it flat on the table with the pink side down.



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2. Remove dropper bottle cap. Put 6 drops into the top hole.


3. Collect nasal swab, swabbing each nostril for about 15 seconds.
4. Insert swab tip into the lower hole of the test card. Push the swab tip from the lower hole until it is visible in the top hole. Turn swab to the right 3 times to mix the swab with the drops.




5. Peel the adhesive liner off and close left side of the card over swab. Press firmly to seal.



6. Read the result at 15 minutes.
7. Interpretation of Results:

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Negative
A negative specimen will give a single pink/purple colored Control Line in the top half of the window, indicating a negative result. This Control Line means that the detection part of the test was done correctly, but no COVID-19 antigen was detected.

Positive
A positive specimen will give two pink/purple colored lines. This means that COVID-19 antigen was detected. Specimens with low levels of antigen may give a faint Sample Line. Any visible pink/purple colored line is positive.

Invalid
If no lines are seen, if just the Sample Line is seen, or the Blue Control Line remains blue, the assay is invalid. Invalid tests should be repeated.

Final Result
No Control Line
Sample Line Only
Blue Control Line Only
Blue Control Line
Sample Line

V Substantial Equivalence Information:

A Predicate Device Name(s):
QuickVue COVID-19 Test

B Predicate 510(k) Number(s):
K231795

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K243518 | K231795 |
| --- | --- | --- |
| Device Trade Name | BinaxNOW COVID-19 Antigen Self Test | QuickVue COVID-19 Test |
| General Device Characteristic Similarities | | |
| Product Code | QYT | Same |
| Assay Target | SARS-CoV-2 Nucleocapsid Protein | Same |

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| Device & Predicate Device(s): | K243518 | K231795 |
| --- | --- | --- |
| 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. | The QuickVue COVID-19 Test is a visually read lateral flow immunoassay device 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 within the first 5 days from symptom onset. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. |
| | All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. | The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2. |
| | Positive results do not rule out co-infection with other respiratory pathogens. | All negative results are presumptive. Symptomatic individuals with an initial negative test result must be re-tested once between 48 and 72 hours after the first test using either an antigen test or a molecular test for SARS-CoV-2. Negative results do not preclude SARS-CoV-2 infections or other pathogens and should not be used as the sole basis for treatment. |
| | 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. | Positive results do not rule out co-infection with other respiratory pathogens. |
| | The performance characteristics for SARS-CoV-2 were established | 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 |

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VI Standards/Guidance Documents Referenced:

| Document Title | Issued by | Applicable study | Purpose |
| --- | --- | --- | --- |
| Special Controls | | | |
| Special Controls for single-analyte SARS-CoV-2 antigen detection test, an in vitro diagnostic device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen (Special Controls under 21 CFR 866.3984). | FDA/CDRH | All Studies | General Use |
| Consensus Standard | | | |
| ISO 11135:2014, Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices | ISO | Sterility | Declaration of Conformity |
| ISO 11135:2014/Amd 2018, Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices | ISO | Sterility | Declaration of Conformity |
| ISO 10993-7, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals | ISO | Sterility | Declaration of Conformity |
| ISO 11137-1:2015, Sterilization of health care products — Radiation | ISO | Sterility | Declaration of Conformity |

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| Document Title | Issued by | Applicable study | Purpose |
| --- | --- | --- | --- |
| ISO 10993-1:2009, Biological evaluation of Medical Devices Evaluation testing within a risk management process | ISO | Biocompatibility | Declaration of Conformity |
| ISO 10993-1:2018, Biological evaluation of Medical Devices Evaluation testing within a risk management process | ISO | Biocompatibility | Declaration of Conformity |
| ISO 10993-2:2006, Biological Evaluation of Medical Devices Animal welfare requirements | ISO | Biocompatibility | Declaration of Conformity |
| ISO 10993-5:2009, Biological Evaluation of Medical Devices Tests for In vitro cytotoxicity | ISO | Biocompatibility | Declaration of Conformity |
| ISO 10993-10:2013, Biological Evaluation of Medical Devices Tests for irritation and skin sensitization | ISO | Biocompatibility | Declaration of Conformity |
| ISO 14971:2019, Application of risk management to medical devices | ISO | Biocompatibility | Declaration of Conformity |
| USP 41 (2018), (87), Biological reactivity tests, in vitro | USP | Biocompatibility | General Use |
| ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization | ISO | Biocompatibility | General Use |
| ISO 10993-12:2012, Biological evaluation of medical devices - Part 12: Sample preparation and reference materials | ISO | Biocompatibility | General Use |
| ISO 10993-17:2009, Biological evaluation of medical devices - Establishment of allowable limits for leachable substances | ISO | Biocompatibility | General Use |
| ISO 10993-18:2020, Biological Evaluation of Medical Devices Chemical characterization of material | ISO | Biocompatibility | General Use |

## VII Performance Characteristics (if/when applicable):

### A Analytical Performance:

1. Precision/Reproducibility:

A precision study was performed to assess the total variability of the BinaxNOW COVID-19 Antigen Self Test across testing days, operators, and device lots. The testing panel was prepared using inactivated SARS-CoV-2 (isolate USA-WA1/2020) diluted into Negative Clinical Matrix (NCM), comprised of the following sample concentrations: 1X LoD, 5X LoD, 0.05X LOD, and negative. Each test panel consisted of 18 samples and compositions of each panel were randomized for the test operators. 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 5 days x 3 replicates/panel member) for a total of 135 observations per panel member. Testing was completed over a five (5) day period (non-consecutively). All testing was performed according to the assay procedure in the test's IFU.

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Table 1. Overall Precision Study Testing Results

| Sample | Expected Result | N | Percent Agreement with Expected Results (95% Confidence Interval) |
| --- | --- | --- | --- |
| 5X LOD | Positive | 135 | 100.0% (135/135) (97.2-100.0%) |
| 1X LOD | Positive | 135 | 97.8% (132/135) (93.7-99.2%) |
| High Negative* | Negative | 135 | 100.0% (135/135) (97.2-100.0%) |
| Negative | Negative | 135 | 100.0% (135/135) (97.2-100.0%) |

* High Negative = 0.05X LOD

Table 2. Precision Study Agreement with Expected Results - By Lot

| 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%) |
| | Negative | 100% (41/41) (91.4-100.0%) |

# 2. Linearity:

Not applicable; this test device only produces binary qualitative results.

# 3. Analytical Specificity/Interference:

# a) Cross-Reactivity and Microbial Interference Study

Cross reactivity and potential microbial interference with the BinaxNOW COVID-19 Antigen Self Test was evaluated by testing 28 commensal and pathogenic microorganisms that are reasonably likely to be encountered in nasal swab specimens. A total of 9 bacteria, 17 viruses, 1 yeast and 1 negative clinical matrix sample (pooled human nasal wash) were tested. Each organism/virus was tested in five replicates in NCM in the absence (cross-reactivity) and presence (interference) of $3\mathrm{x}$ LoD SARS-CoV-2 (inactivated USA-WA1/2020) in a randomized and blinded manner. No cross-reactivity or interference was seen with the microorganisms in the table below when tested at $1\times 10^{6}$ CFU/mL for bacteria and yeast and at $1\times 10^{5}$ TCID $_{50}$ /mL for viruses. Results are summarized below, reflecting the number of SARS-CoV-2 positive results obtained.

Table 3. Microorganisms evaluated for Cross-Reactivity and Microbial Interference

| Type | Microorganism | Cross-reactivity | Microbial Interference |
| --- | --- | --- | --- |
| Viruses | Human Adenovirus 1 | 0% (0/5) | 100% (5/5) |
| | Human Coronavirus 229E | 0% (0/5) | 100% (5/5) |
| | Human Coronavirus NL63 | 0% (0/5) | 100% (5/5) |

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| Type | Microorganism | Cross-reactivity | Microbial Interference |
| --- | --- | --- | --- |
| | Human Coronavirus OC43 | 0% (0/5) | 100% (5/5) |
| | Human Coronavirus HKU1* | 0% (0/5) | 100% (5/5) |
| | Enterovirus 70 | 0% (0/5) | 100% (5/5) |
| | Human Metapneumovirus (hMPV) | 0% (0/5) | 100% (5/5) |
| | Human Parainfluenza virus 1 | 0% (0/5) | 100% (5/5) |
| | Human Parainfluenza virus 2 | 0% (0/5) | 100% (5/5) |
| | Human Parainfluenza virus 3 | 0% (0/5) | 100% (5/5) |
| | Human Parainfluenza virus 4 | 0% (0/5) | 100% (5/5) |
| | RSV A | 0% (0/5) | 100% (5/5) |
| | Rhinovirus 1A | 0% (0/5) | 100% (5/5) |
| | MERS-coronavirus | 0% (0/5) | 100% (5/5) |
| | Human Influenza A/California/07/09 | 0% (0/5) | 100% (5/5) |
| | Human Influenza A/New Caledonia/20/99 | 0% (0/5) | 100% (5/5) |
| | Human Influenza A/Brisbane/02/18 | 0% (0/5) | 100% (5/5) |
| | Human Influenza B/Wisconsin/1/10 | 0% (0/5) | 100% (5/5) |
| Bacteria | Bordetella pertussis | 0% (0/5) | 100% (5/5) |
| | Chlamydia pneumoniae | 0% (0/5) | 100% (5/5) |
| | Haemophilus influenzae | 0% (0/5) | 100% (5/5) |
| | Legionella pneumophila | 0% (0/5) | 100% (5/5) |
| | Mycoplasma pneumoniae | 0% (0/5) | 100% (5/5) |
| | Staphylococcus aureus | 0% (0/5) | 100% (5/5) |
| | Staphylococcus epidermidis | 0% (0/5) | 100% (5/5) |
| | Streptococcus pneumoniae | 0% (0/5) | 100% (5/5) |
| | Streptococcus pyogenes | 0% (0/5) | 100% (5/5) |
| Yeast | Candida albicans | 0% (0/5) | 100% (5/5) |
| Other | Pooled Human Nasal Wash | 0% (0/5) | 100% (5/5) |

*Human Coronavirus HKU1 was evaluated as a clinical sample in VTM (i.e., not cultured). Accordingly, the relative concentration was quantified in Ct-values, wherein four positive clinical samples ranging from 22.3 – 32.0 Ct were evaluated herein. No cross-reactivity or interference with SARS-CoV-2 was observed.

# b) Endogenous and Exogenous Interfering Substances Study

An interfering substances study was conducted to assess if frequently encountered endogenous or exogenous substances interfere with the performance of the BinaxNOW COVID-19 Antigen Self Test. Each potentially interfering substance was tested in five replicates in negative clinical nasal swab matrix in the presence or absence of 3x LoD SARS-CoV-2 (USA-WA1/2020) and at concentrations as indicated in Table 4 below. Samples were prepared by applying $20~\mu \mathrm{L}$ of sample to the dry swab and thereafter swabs were processed according to the test instructions for use using one lot of test device. The effects of the substances were evaluated by the agreement with the expected positive or negative results. None of the evaluated substances demonstrated interference with the assay at the tested concentrations. Results are summarized below, reflecting the number of SARS-CoV-2 positive results obtained.

Table 4. Endogenous and Exogenous Substances evaluated for Interference

| Substance | Active Ingredient | Concentration | Cross-reactivity | Interference |
| --- | --- | --- | --- | --- |
| Throat Lozenge | Menthol, Benzocaine | 3 mg/mL | 0% (0/5) | 100% (5/5) |
| Soybean | Menthol, Benzocaine | 3 mg/mL | 0% (0/5) | 100% (5/5) |
| Soybean | Menthol, Benzocaine | 3 mg/mL | 0% (0/5) | 100% (5/5) |
| Soybean | Menthol, Benzocaine | 1 mg/mL | 0% (0/5) | 100% (5/5) |
| Soybean | Menthol, Benzocaine | 100% (5/5) | 0% (0/5) | 100% (5/5) |

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| Substance | Active Ingredient | Concentration | Cross-reactivity | Interference |
| --- | --- | --- | --- | --- |
| Sore Throat Spray | Phenol | 5% w/v | 0% (0/5) | 100% (5/5) |
| OTC Nasal Spray 1 | Mometasone Furoate | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC Nasal Spray 2 | Triamcinolone | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC Nasal Spray 3 | Budesonide | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC Nasal Spray 4 | Fluticasone | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC nasal gel | Sodium Chloride with Preservatives | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC Nasal Spray 5 | Phenylephrine | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC Nasal Spray 6 | Oxymetazoline | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC Nasal Spray 7 | Cromolyn | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC Homeopathic Nasal Spray | Zicam (Galphimia glauca, Histaminum hydrochloricum, Luffa operculate, sulfur) | 15% v/v | 0% (0/5) | 100% (5/5) |
| OTC Homeopathic Nasal Wash | Alkalol | 15% v/v | 0% (0/5) | 100% (5/5) |
| Hand Sanitizer | Ethyl Alcohol 62% | 1% w/v | 0% (0/5) | 100% (5/5) |
| Hand Soap | | 1% w/v | 0% (0/5) | 100% (5/5) |
| Endogenous | Whole Blood | 2.5% v/v | 0% (0/5) | 100% (5/5) |
| Endogenous | Mucin | 2.5 mg/mL | 0% (0/5) | 100% (5/5) |
| Endogenous | Leukocytes | 5 x 10^{6} cells/mL | 0% (0/5) | 100% (5/5) |
| Antibiotic, Nasal Ointment | Mupirocin | 10 mg/mL | 0% (0/5) | 100% (5/5) |
| Nasal Corticosteroid 1 | Beclomethasone | 15% v/v | 0% (0/5) | 100% (5/5) |
| Nasal Corticosteroid 2 | Dexamethasone | 15% v/v | 0% (0/5) | 100% (5/5) |
| Nasal Corticosteroid 3 | Flunisolide | 15% v/v | 0% (0/5) | 100% (5/5) |
| Anti-Viral Drug 1 | Tamiflu (Oseltamivir Phosphate) | 5 mg/mL | 0% (0/5) | 100% (5/5) |
| Anti-Viral Drug 2 | Remdesivir | 5 mg/mL | 0% (0/5) | 100% (5/5) |
| Anti-Viral Drug 3 | Molnupiravir | 5 mg/mL | 0% (0/5) | 100% (5/5) |
| Antibiotic | Tobramycin | 1.44 mg/mL | 0% (0/5) | 100% (5/5) |
| Anti-Viral Drug | Zanamivir | 281.5 ng/mL | 0% (0/5) | 100% (5/5) |

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4. Assay Reportable Range:

Not applicable; this test device only produces qualitative results.

5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):

a) Internal Controls

The test uses an internal control antibody immobilized onto the test strip that forms a line distinct from the analyte specific test line on each individual test. The pink-to-purple line at the "Control" position serves as an internal procedural control. If the test flows and the reagents work, this line will always appear.

b) Reagent Stability and Shelf-life

In order to determine the shelf-life of the BinaxNOW COVID-19 Antigen Self Test in the intended storage conditions (15-30°C), real-time stability studies were conducted using three lots of each test kit component. Component lots were stored at room temperature (28-32°C) and were held at these conditions for the duration of the study.

The test components were tested at specified time points using positive test samples with analyte concentrations near the LoD of the test (≤3X LoD) and negative test samples (Negative Clinical Matrix).

Results obtained at each storage timepoint were compared to testing at baseline (t=0). Data collected to date across all real-time shelf-life studies support a test kit shelf-life of 22 months.

6. Detection Limit:

a) Limit of Detection

The limit of detection (LoD) of the BinaxNOW COVID-19 Antigen Self Test was determined by evaluating different dilutions of SARS-CoV-2 in negative clinical matrix (NCM), using two strains: 1) heat inactivated SARS-CoV-2 isolate USA-WA1/2020; and 2) heat inactivated SARS-CoV-2 Omicron variant lineage B.1.1.529. A total of three lots of test devices were used across each of the two strains. Samples were prepared by inoculating a dry swab with 20 μL of the indicated dilution and then processing the swab according to the test instructions for use.

1:10 serial dilutions were first prepared in NCM and tested in triplicate on each of three lots of BinaxNOW COVID-19 Antigen Self Test until negative results were generated for all replicates. Thereafter, 1:2 serial dilutions were prepared (starting from the lowest 1:10 dilution level that produced positive results for all replicates) and were tested in 20 replicates until <95% of results were positive. The preliminary LOD was determined to be the lowest level tested that produced 100% positive results (n=20) on all three lots of test devices.

Confirmation of the preliminary LOD was performed by preparing dilutions to 0.5X, 1X, and 2X the preliminary LOD determined for each SARS-CoV-2 strain. Each dilution was

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tested in 60 replicates per lot. The final LoD for the SCoV-2 Ag Detect Rapid Test was determined to be:

SARS-CoV-2 isolate USA-WA1/2020: $3.5 \times 10^{3} \mathrm{TCID}_{50} / \mathrm{mL}$
SARS-CoV-2 Omicron variant lineage B.1.1.529: $1.6 \times 10^{3} \mathrm{TCID}_{50} / \mathrm{mL}$

Table 6. Limit of Detection - Confirmatory Study Results

| USA-WA1/2020 | | | |
| --- | --- | --- | --- |
| SARS-CoV-2 Concentration (TCID50/mL) | Lot 1 | Lot 2 | Lot 3 |
| 7,000 | 60/60 (100.0 %) | 60/60 (100.0 %) | 60/60 (100.0 %) |
| 3,500 | 60/60 (100.0 %) | 60/60 (100.0 %) | 60/60 (100.0 %) |
| 1,750 | 47/60 (78.3%) | 37/60 (61.7%) | 21/60 (35.0%) |
| B.1.1.529 (Omicron) | | | |
| SARS-CoV-2 Concentration (TCID50/mL) | Lot 1 | Lot 2 | Lot 3 |
| 3,206.4 | 60/60 (100.0 %) | 60/60 (100.0 %) | 60/60 (100.0%) |
| 1,603.2 | 60/60 (100.0 %) | 60/60 (100.0 %) | 59/60 (98.3%) |
| 801.6 | 19/60 (31.7%) | 12/60 (20.0%) | 6/60 (10.0%) |

Table 7. Limit of Detection - Final Results

| Strain | LoD (TCID50/mL) | LoD (TCID50/swab) |
| --- | --- | --- |
| USA-WA1/2020 | 3,500 | 70 |
| B.1.1.529 (Omicron) | 1603.2 | 32.064 |

# b) International Standard Material NIBSC code: 21/368 - Limit of Detection

The LoD of the BinaxNOW COVID-19 Antigen Self Test was also determined by evaluating different dilutions of the International Standard Material for SARS-CoV-2 antigen (NIBSC code: 21/368) in NCM. The SARS-CoV-2 standard containing lyophilized SARS-CoV-2 antigen was reconstituted in $250~\mu \mathrm{L}$ of ultra pure water for a final concentration of 20,000 IU/mL. Swab samples were prepared by dispensing $20~\mu \mathrm{L}$ of the testing dilution onto a swab head and tested according to the test instructions.

The LoD was determined as the lowest virus concentration that was detected $\geq 95\%$ of the time (i.e., concentration at which at least 19 out of 20 replicates tested positive). The limit of detection was established in two phases. For the preliminary LoD, five serial 1:2 dilutions were prepared in NCM and tested in triplicate on the BinaxNOW COVID-19 Antigen Self Test until negative results were generated for all replicates. Confirmation of the preliminary LoD (500 IU/mL) was performed by preparing 17 additional swabs with the preliminary LoD dilution and testing on BinaxNOW COVID-19 Antigen Self-Test (added to the initial triplicate results for a total of twenty replicates). The results are summarized below.

Table 7. Limit of Detection - International Standard Material NIBSC code: 21/368

| Standard Material (IU/mL) | % Detected (n/N) |
| --- | --- |
| 500 | 100% (20/20) |
| 375 | 100% (20/20) |
| 250 | 20% (4/20) |

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The analytical sensitivity (LoD) for the BinaxNOW COVID-19 Antigen Self Test with the International Standard Material NIBSC code: 21/368 for SARS-CoV-2 Antigen is $375\mathrm{IU / mL}$ or $7.5\mathrm{IU / swab}$ .

# 7. High-dose Hook Effect

A high-dose Hook Effect study was conducted to assess the performance of the BinaxNOW COVID-19 Antigen Self Test for a potential hook effect at high concentrations of SARS-CoV-2 (i.e., false negatives). Positive samples were prepared from inactivated SARS-CoV-2 (USA-WA1/2020) at three high concentrations. Positive and negative samples (comprising negative clinical matrix only) were tested in five replicates each, per the IFU. Test samples were prepared by a study operator and then provided to different operators who were blinded to the sample identity to perform the test. No high dose hook effect was observed when tested with up to a concentration of $1.4 \times 10^{6} \mathrm{TCID}_{50} / \mathrm{mL}$ of inactivated SARS-CoV-2 virus with the BinaxNOW COVID-19 Antigen Self Test.

| Sample | Concentration | % Detected (n/N) |
| --- | --- | --- |
| SARS-CoV-2 | 1.4 x 106TCID50/mL | 100% (5/5) |
| | 7.0 x 105TCID50/mL | 100% (5/5) |
| | 7.0 x 104TCID50/mL | 100% (5/5) |
| Negative | 0 TCID50/mL | 100% (5/5) |

# 8. Inclusivity (Analytical Reactivity)

An inclusivity study was performed to demonstrate that the BinaxNOW COVID-19 Antigen Self Test can detect the nucleocapsid protein across a variety of SARS-CoV-2 strains. 19 variants of SARS-CoV-2 were prepared in NCM and each tested in five replicates. $20\mu \mathrm{L}$ of the dilutions were applied directly to the dry swab head and swabs processed according to the test instructions for use. The lowest concentration that produces 5/5 COVID-19 positive results were considered the $100\%$ detection rate. Results are summarized below.

Table 7. Analytical Reactivity with SARS-CoV-2 Variants

| SARS-CoV-2 Variant | Concentration (TCID50/mL) | % Positive (n/N) |
| --- | --- | --- |
| Alpha (B.1.1.7) | 3.50 x 104 | 100% (5/5) |
| Beta (B.1.351) | 7.00 x 103 | 100% (5/5) |
| Delta (B.1.617.2) | 1.75 x 103 | 100% (5/5) |
| Gamma (P.1) | 1.75 x 103 | 100% (5/5) |
| Iota (B.1.526) | 7.00 x 103 | 100% (5/5) |
| Italy-INMI1 | 3.50 x 104 | 100% (5/5) |
| Kappa (B.1.617.1) | 1.05 x 104 | 100% (5/5) |
| Omicron (BA 2.3) | 2.63 x 103 | 100% (5/5) |
| Omicron (BA.2.12.1) | 1.31 x 103 | 100% (5/5) |
| Omicron (BA.2.75.5) | 8.75 x 102 | 100% (5/5) |
| Omicron (BA.4.6) | 3.50 x 103 | 100% (5/5) |
| Omicron (BA.5) | 5.60 x 104 | 100% (5/5) |
| Omicron (BA.5.5) | 1.10 x 102 | 100% (5/5) |
| Omicron (BF.5) | 3.50 x 103 | 100% (5/5) |
| Omicron (BF.7) | 1.40 x 104 | 100% (5/5) |

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| SARS-CoV-2 Variant | Concentration (TCID50/mL) | % Positive (n/N) |
| --- | --- | --- |
| Omicron (BQ.1) | 7.00 x 103 | 100% (5/5) |
| Omicron (BQ1.1) | 8.75 x 102 | 100% (5/5) |
| Omicron (JN.1)* | 3.63 x 102 | 100% (5/5) |
| Omicron (XBB) | 2.80 x 104 | 100% (5/5) |
| Zeta (P.2) | 3.50 x 103 | 100% (5/5) |

*Units quantified in terms of IFU/mL, instead of $\mathrm{TCID}_{50} / \mathrm{mL}$ .

# 9. Assay Cut-Off:

Not applicable; this test device only produces qualitative results.

# B Comparison Studies:

1. Method Comparison with Predicate Device:

See Section C (Clinical Studies) below.

2. Matrix Comparison:

The BinaxNOW COVID-19 Antigen Self Test is only intended for qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens. As no other sample type is claimed for this device, a matrix comparison study to support other sample types for clinical testing with this device was not performed.

# C Clinical Studies:

The performance of the BinaxNOW COVID-19 Antigen Self Test in detecting SARS-CoV-2 viral nucleoprotein antigen from anterior nasal swab samples was evaluated in a multi-center, prospective study with lay users in the U.S. during two distinct time frames ranging from November 2020 to July 2022. Across six sites, a total of 606 untrained lay users were enrolled into the study and self-tested (or tested another). The study only enrolled subjects with symptoms of respiratory infection consistent with SARS-CoV-2 infection.

An anterior nasal (AN) swab was self-collected by each study subject and immediately tested with the BinaxNOW COVID-19 Antigen Self Test according to the test device's quick reference instructions. A second swab was collected by the study operator (either an AN swab or mid-turbinate swab), placed into a transport tube containing viral transport media, refrigerated, and shipped to a central lab for testing with a highly sensitive RT-PCR comparator assay. The investigational sample was collected first, followed then by the comparator swab. Demographics, symptom information, and health history were also collected from each subject.

There were 606 evaluable subjects with an average age of 37 years. Approximately $43\%$ (262/606) were male and $56\%$ (342/606) were female (2 subjects were undisclosed; $0.33\%$ ). A total of 159 subjects of the total 765 enrolled were excluded because they did not meet the inclusion criteria, or their samples had invalid or missing comparator results. Results obtained with the BinaxNOW COVID-19 Antigen Self Test were compared to the results obtained with a highly sensitive RT-PCR comparator test to determine agreement with the true clinical status of the patient.

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The BinaxNOW COVID-19 Antigen Self Test demonstrated a positive percent agreement (PPA) of 86.9% (186/214; 95% CI: 81.7% - 90.8%) and a negative percent agreement (NPA) of 98.5% (384/390; 95% CI: 96.7% - 99.3%) when compared to the comparator method.

Table 8. Performance of BinaxNOW COVID-19 Antigen Self Test against RT-PCR Comparator

| | RT-PCR Comparator | | | |
| --- | --- | --- | --- | --- |
| | | Positive | Negative | Total |
| BinaxNOW COVID-19 Antigen Self Test | Positive | 186 | 6 | 192 |
| | Negative | 28 | 384 | 412 |
| | Total | 214 | 390 | 604 |

PPA: 86.916% (186/214; 95% CI: 81.7% - 90.8%)
NPA: 98.462% (384/390; 95% CI: 96.7% - 99.3%)

Table 9. Performance Metrics of BinaxNOW COVID-19 Antigen Self Test stratified by Days Post-Symptom Onset (DPSO)

| Days Post-Symptom Onset | PPA by DPSO | NPA by DPSO |
| --- | --- | --- |
| Day 0 | 69.23% (9/13) | 100.00% (24/24) |
| Day 1 | 89.71% (61/68) | 98.92% (92/93) |
| Day 2 | 86.36% (57/66) | 100.00% (97/97) |
| Day 3 | 86.67% (39/45) | 97.78% (88/90) |
| Day 4 | 83.33% (10/12) | 96.61% (57/59) |
| Day 5 | 100.00% (10/10) | 96.30% (26/27) |

Table 10. Performance of the BinaxNOW COVID-19 Antigen Self Test stratified by sample collection timeframe.

| Dominant Variant | Study Date Range | PPA | NPA |
| --- | --- | --- | --- |
| Pre-Omicron (n=295) | November 2020 – March 2021 | 81.61% (71/87) | 98.56% (205/208) |
| Omicron (n=309) | February 2022 – July 2022 | 90.55% (115/127) | 98.35% (179/182) |

1. Clinical Sensitivity:

Refer to Section VII.C (Clinical Studies) above for the clinical validation, including test sensitivity/positive percent agreement (PPA). The PPA for the test is 86.916% (186/214; 95% CI: 81.7% - 90.8%).

2. Clinical Specificity:

Refer to Section VII.C (Clinical Studies) above for the clinical validation, including test specificity/negative percent agreement (NPA). The NPA for the test is 98.462% (384/390; 95% CI: 96.7% - 99.3%).

3. Serial Testing

This clinical data set verifies the known lower sensitivity for samples collected on the day of symptom onset (i.e., Day 0) that was observed for test devices of similar technology and design across a multitude of clinical studies. As a mitigation, the Intended Use for this test device (and associated Instructions for Use) include recommendations for repeat testing (i.e.,

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test at least twice over three days with at least 48 hours between tests). This mitigation is supported by data generated by the National Institutes for Health (NIH) and the University of Massachusetts Chan Medical School (in collaboration with the FDA) demonstrating that repeat testing over multiple days improves test performance and increases the likelihood that a COVID-19 antigen test will accurately detect an infection. These results have informed the FDA's general understanding that repeat testing after a negative result from a COVID-19 antigen test reduces the risk of a false negative result. Please refer to the following studies for additional details:

- Finding a Needle in the Haystack: Design and Implementation of a Digital Site-less Clinical Study of Serial Rapid Antigen Testing to Identify Asymptomatic SARS-CoV-2 Infection - https://www.medrxiv.org/content/10.1101/2022.08.04.22278274v1.
- Performance of Screening for SARS-CoV-2 using Rapid Antigen Tests to Detect Incidence of Symptomatic and Asymptomatic SARS-CoV-2 Infection: findings from the Test Us at Home prospective cohort study - https://www.medrxiv.org/content/10.1101/2022.08.05.22278466v1.

## D Clinical Cut-Off:

The Clinical Cut-off study is not applicable, as there is not clinical cutoff related to the presence of SARS-CoV-2 in patient samples.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

## IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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