Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a traditional lateral flow immunoassay, with no mention of AI or ML for result interpretation or any other function.

Therapeutic

No
The device is a diagnostic test for detecting SARS-CoV-2 antigens, not for providing therapy or treatment. The intended use explicitly states it should not be used for treatment.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that "The QuickVue COVID-19 Test is a... device intended for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens," which serves the purpose of identifying the presence of a disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical lateral flow immunoassay device with a test strip and reagent tube, indicating it is a hardware-based diagnostic test, not software only.

IVD (In Vitro Diagnostic)

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 is a diagnostic purpose, aiming to identify the presence of a specific substance (SARS-CoV-2 antigens) in a biological sample (nasal swab).
Device Description: The description details a "lateral flow immunoassay device" that reacts with viral antigens in a specimen to produce a visual result (lines on a test strip). This is a common format for in vitro diagnostic tests.
Performance Studies: The document includes a "Method Comparison" study where the device's performance is compared to an "EUA extracted SARS-CoV-2 RT-PCR assay". This type of study is conducted to evaluate the diagnostic accuracy of the device.
Key Metrics: The document provides "Positive Percent Agreement (PPA)" and "Negative Percent Agreement (NPA)", which are standard metrics used to assess the performance of diagnostic tests.

All these elements align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

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 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 January 2021 to February 2024 when COVID-19 variants Alpha, 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 (comma separated list FDA assigned to the subject device)

QYT

Device Description

The QuickVue COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

To begin the test, a self-collected anterior nasal swab sample (in individuals aged 14 and older or individuals between the age of 2 to 14 a swab collected by a parent or guardian), or a healthcare collected anterior nasal swab sample is inserted into the pre-filled reagent tube. The reagent disrupts the virus particles in the specimen, exposing internal viral nucleocapsid antigens. The test strip is then placed in the reagent tube where the viral nucleocapsid antigens in the specimen will react with the reagents in the test strip.

If the extracted specimen contains SARS-CoV-2 viral nucleocapsid antigens, a pink-to-red test line along with a blue procedural control line will appear on the test strip indicating a positive result. If SARS-CoV-2 viral nucleocapsid antigens are not present, or are present at very low levels, only the blue procedural control line will appear.

Components:

Individually Packaged Test strips (2, 4, or 25 per kit)
Reagent Tubes containing Reagent Solution (2, 4, or 25 per kit)
Nasal Swabs (2, 4, or 25 per kit)
User Instructions (1 per kit)
Strip Placement Card (2 per kit)
QVue Mobile Application (Optional) - Available for download using the QR code located on the Unit Carton

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior nasal (nares) swab specimens

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

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

The performance of the QuickVue COVID-19 Test was compared to a SARS-CoV-2 RT-PCR assay in a prospective clinical study. Eight (8) clinical sites participated in the study. Samples were collected by lay users from themselves or collected for a household member. A total of 878 subjects were enrolled in this study.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Limit of Detection (LoD)
- Sample Size: 20 replicates for each concentration determined
- Key Results: The LoD for SARS-CoV-2 strain WA1/2020 was 3.03E+04 TCID50/mL (1.52E+03 TCID50/Swab). The LoD for SARS-CoV-2 strain Omicron BA.5 was 2.48E+04 TCID50/mL (1.24E+03 TCID50/Swab).
Study Type: Inclusivity (Analytical Reactivity)
- Sample Size: 5 replicates per concentration
- Key Results: Detected SARS-CoV-2, Omicron BA.1 (minimum detectable concentration 7.08E+04 TCID50/mL) and SARS-CoV-2, Delta (minimum detectable concentration 3.00E+04 TCID50/mL).
Study Type: Cross Reactivity/Microbial Interference
- Sample Size: 5 replicates for each organism/virus tested, in the absence or presence of 6.06E+04 TCID30mL of heat-inactivated SARS-CoV-2 (isolate USA-WA1/2020).
- Key Results: None of the tested organisms and viruses showed cross-reactivity or interference except for SARS-Coronavirus, which showed cross-reactivity as expected.
Study Type: Interfering Substances
- Sample Size: 5 replicates for each substance tested, in the absence of 6.06E+04 TCIDsylmL of heat-inactivated SARS-CoV-2 (isolate USA-WA1/2020).
- Key Results: None of the 24 substances tested interfered with the assay.
Study Type: Hook Effect
- Sample Size: 5 replicates for each concentration of heat-inactivated SARS-CoV-2.
- Key Results: No Hook (Prozone) Effect was displayed for concentrations ranging from 1.09E+06 to 9.09E+04 TCID50mL (40X to 3X LoD). All spiked samples were 100% positive at all tested concentrations.
Study Type: Flex Studies
- Key Results: The assay does not present a significant risk of an erroneous result when performed by the lay user under various conditions (operating environment, extraction time, light sources, disturbance during analysis, open pouch, development time, running steps out of order, swab agitation, extraction reagent disturbance, sample temperature, sample stability).
Study Type: Precision (Lot-to-lot)
- Sample Size: 240 replicates per lot for each reader and each concentration (negative, 1XLoD, 4XLoD) across three product lots. Tested in duplicate in 2 events per day over 20 days with 2 operators.
- Key Results:
  - Negative: Reader 1: 240/240 (100%), Reader 2: 240/240 (100%). %Agreement (95%CI): 100% [98.4% - 100.0%].
  - Low Positive (1XLoD): Reader 1: 238/240 (99.2%), Reader 2: 238/240 (99.2%). %Agreement (95%CI): 99.2% [97.0% - 99.8%].
  - Moderate Positive (4XLoD): Reader 1: 240/240 (100%), Reader 2: 240/240 (100%). %Agreement (95%CI): 100% [98.4% - 100.0%].
Study Type: Method Comparison (Prospective Clinical Study)
- Sample Size: 878 subjects (39.6% male, 60.4% female), 780 subjects included in analysis for symptomatic individuals within 5 days post symptom onset.
- Key Results:
  - PPA: 82.0% (164/200) (95% CI: 76.1% - 86.7%)
  - NPA: 99.1% (575/580) (95% CI: 98.0% - 99.6%)
  - PPA results by Days Post Symptom Onset (DPSO):
    - 0 DPSO: 87.5% (14/16)
    - 1 DPSO: 81.1% (45/53)
    - 2 DPSO: 79.4% (52/63)
    - 3 DPSO: 92.9% (27/28)
    - 4 DPSO: 75.0% (21/28)
    - 5 DPSO: 83.3% (10/12)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Positive Percent Agreement (PPA): 82.0%
Negative Percent Agreement (NPA): 99.1%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

ACON Flowflex COVID-19 Antigen Home Test (K230828)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

N/A

Summary

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Image /page/0/Picture/0 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Quidel Corporation Suzanne Thomas Sr. Regulatory Affairs Manager 10165 McKellar Court San Diego, California 92121

March 22, 2024

Re: K231795

Trade/Device Name: QuickVue COVID-19 Test 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: June 16, 2023 Received: June 20, 2023

Dear Suzanne Thomas:

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" (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).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting 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.

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).

Sincerely,

Uwe Scherf -S

Uwe Scherf, M.S., Ph.D. Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K231795

Device Name QuickVue COVID-19 Test

Indications for Use (Describe)

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 nonprescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

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 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 January 2021 to February 2024 when COVID-19 variants Alpha, 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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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Image /page/4/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square with rounded corners, divided into four quadrants. The top-left quadrant is a gradient of colors, including red, orange, yellow, and green. The top-right quadrant is light blue, and the bottom-left quadrant is dark blue. The bottom-right quadrant is purple. Below the square is the word "QUIDEL" in a sans-serif font.

510(K) SUMMARY

I. Submitter

Quidel Corporation 10165 McKellar Court San Diego, CA 92121 Telephone: (800) 874-1517

Submission Contact

Suzanne Thomas Sr. Regulatory Affairs Manager 678-727-8786 Sue.thomas@quidelortho.com

Date Prepared

March 22, 2024

Proprietary and Established Names

QuickVue COVID-19 Test

Common Name

Coronavirus Antigen Detection Test

II. Device Classification

| Product | Product
Code | Classification | Regulatory
Section | Description |
|---------|-----------------|----------------|-----------------------|----------------------------------------------|
| Assay | QYT | II | 21 CFR 866.3984 | Over-the-Counter
COVID-19
antigen test |

Panel

Microbiology

Predicate Device

ACON Flowflex COVID-19 Antigen Home Test (K230828; cleared 11/09/2023)

III. Device Description

The QuickVue COVID-19 Test is a lateral flow immunoassay device intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2. The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

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Image /page/5/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square shape with rounded corners, filled with a gradient of colors resembling a rainbow spectrum. Below the square is the word "QUIDEL" in a simple, sans-serif font. The overall design is clean and modern, suggesting a company involved in technology or healthcare.

To begin the test, a self-collected anterior nasal swab sample (in individuals aged 14 and older or individuals between the age of 2 to 14 a swab collected by a parent or guardian), or a healthcare collected anterior nasal swab sample is inserted into the pre-filled reagent tube. The reagent disrupts the virus particles in the specimen, exposing internal viral nucleocapsid antigens. The test strip is then placed in the reagent tube where the viral nucleocapsid antigens in the specimen will react with the reagents in the test strip.

If the extracted specimen contains SARS-CoV-2 viral nucleocapsid antigens, a pink-to-red test line along with a blue procedural control line will appear on the test strip indicating a positive result. If SARS-CoV-2 viral nucleocapsid antigens are not present, or are present at very low levels, only the blue procedural control line will appear.

Component	2-Test	4-Test	25-Test
Individually Packaged Test strips	2	4	25
Reagent Tubes containing Reagent Solution	2	4	25
Nasal Swabs	2	4	25
User Instructions	1	1	1
Strip Placement Card	2	2	2
QVue Mobile Application (Optional)	Available for download using the QR
code located on the Unit Carton

Assay Components

IV. Intended Use

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.

The QuickVue COVID-19 Test does not differentiate between SARS-CoV and SARS-CoV-2.

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 January 2021 to February 2024 when COVID-19 variants Alpha, Delta, and Omicron were dominant. Test accuracy may change as new

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Image /page/6/Picture/0 description: The image contains the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, filled with a gradient of colors resembling a rainbow. The bottom right corner of the square is a solid blue color. Below the square is the word "QUIDEL" in a simple sans-serif font.

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.

| Features | Proposed Device
QuickVue COVID-19 Test | Predicate Device
Flowflex COVID-19 Antigen Home Test
K230828 |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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.
The QuickVue COVID-19 Test does not
differentiate between SARS-CoV and SARS-
CoV-2.
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 January 2021 to
February 2024 when COVID-19 variants
Alpha, Delta, and Omicron were dominant.
Test accuracy may change as new SARS-CoV- | The Flowflex COVID-19 Antigen Home
Test is a visually read lateral flow
immunoassay device intended for the
rapid, qualitative detection of SARS-CoV-
2 virus nucleocapsid protein antigen
directly in anterior nasal swab specimens
from individuals with signs and symptoms
of COVID19 within the first 6 days of
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. The Flowflex COVID-19 Antigen
Home Test does not differentiate between
SARS-CoV and SARS-CoV-2. 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
December 2022 to March 2023 when
SARS-CoV-2 Omicron was dominant.
Test accuracy may change as new SARS-
CoV-2 viruses emerge. Additional testing
with a lab-based molecular test (e.g., PCR) |
| | 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. | should be considered in situations where a new virus or variant is suspected. |
| Qualitative | Yes | Same |
| Analyte | SARS-CoV-2 nucleocapsid protein antigen | Same |
| Intended Use Population | Individuals with symptoms of COVID-19 | Same |
| Specimen Type | Direct anterior nasal swab specimens | Same |
| Test Principle | Lateral flow immunoassay | Same |
| Format | Test strip | Test cassette |
| Development Time | 10 min | 15-30 min |
| Storage | Room Temperature (15°C - 30°C) | Same |
| Use Setting (OTC or Rx) | OTC | OTC |
| Rapid test | Yes | Same |
| Result Interpretation | Visual read | Same |
| Utilizes App to display results | Optional | Optional |

V. Comparison with Predicate Device

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Image /page/7/Figure/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square divided into four quadrants, with the top left quadrant displaying a spectrum of colors from yellow to red. The bottom right quadrant is filled with shades of blue and purple. Below the square is the word "QUIDEL" in a simple, sans-serif font.

VI. Performance Data

Numerous studies were undertaken to document the performance characteristics and the substantial equivalence of the test to the predicate device. The performances studies included:

Limit of Detection

The Limit of Detection (LoD) of the QuickVue COVID-19 Test was determined by evaluating different dilutions of heat-inactivated SARS-CoV-2. isolate USA-WA1/2020, and dilutions of SARS CoV-2, isolate Omicron BA.5, in negative nasal matrix (NNM). 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 limit of detection for the QuickVue COVID-19 Test using SARS-CoV-2 strain WA1/2020 was confirmed to be 3.03E+04 TCIDsy/mL. The limit of detection for the QuickVue COVID-19 Test with SARS-CoV-2 strain Omicron BA.5 was confirmed to be 2.48E+04 TCID50/mL.

| Analyte Strain | LoD Concentration
(TCID50/mL) | LoD Concentration
(TCID50/Swab) |
|-----------------|----------------------------------|------------------------------------|
| WA1/2020/ Alpha | 3.03E+04 | 1.52E+03 |
| Omicron / BA.5 | 2.48E+04 | 1.24E+03 |

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Image /page/8/Picture/0 description: The image features the logo for Quidel. The logo consists of a square shape with rounded corners, divided into four quadrants. The top and left quadrants are filled with a gradient of colors, including red, orange, yellow, green, blue, and purple. The bottom right quadrant is filled with a solid blue color. Below the square shape, the word "QUIDEL" is written in a sans-serif font.

Inclusivity (Analytical Reactivity)

Analytical reactivity for OuickYue COVID-19 Test was demonstrated using 2 additional strains/isolates of SARS CoV-2 virus. Heat-inactivated SARS-CoV-2 isolates Omicron BA.1 and Delta stocks were each diluted into NNM at different concentrations. Each concentration was tested with 5 replicates until two consecutive dilutions produced one or more negative replicates out of 5.

The QuickVue COVID-19 Test detected the viral strains/isolates SARS-CoV-2, Omicron BA.1 and SARS-CoV-2, Delta. The minimum detectable concentration of SARS-CoV-2, Omicron BA.1 was 7.08E+04 TCID50/mL. The minimum detectable concentration of SARS-CoV-2, Delta was 3.00E+04 TCID50mL.

Cross Reactivity/Microbial Interference

The cross-reactivity and potential interference were evaluated by testing various microorganisms (21), viruses (39), and negative matrix (1) with the QuickVue COVID-19 Test. Each organism and virus were tested in five (5) replicates in the absence or presence of 6.06E+04 TCID30mL of heat-inactivated SARS-CoV-2 (isolate USA-WA1/2020). None of the organisms and viruses below in Table 1 showed crossreactivity and interference in the assay at the concentrations listed except for SARS-Coronavirus. Crossreactivity was observed on SARS-Coronavirus sample as expected.

| Virus/Bacteria/Parasite | Strain/ID | Concentration | Units | Cross-
Reactivity
(Yes/No) | Interference
(Yes/No) |
|-------------------------------------------------------------------------------------------------------|-----------------------|---------------|-----------|----------------------------------|--------------------------|
| Adenovirus | Type 1 | 1.41E+05 | TCID50/mL | No | No |
| Adenovirus | Type 2 | 1.04E+05 | TCID50/mL | No | No |
| Adenovirus | Type 3 | 1.05E+05 | TCID50/mL | No | No |
| Adenovirus | Type 4 | 1.78E+05 | TCID50/mL | No | No |
| Adenovirus | Type 5 | 1.58E+05 | TCID50/mL | No | No |
| Adenovirus | Type 7 | 1.90E+05 | TCID50/mL | No | No |
| Adenovirus | Type 11 | 1.47E+05 | TCID50/mL | No | No |
| Adenovirus | Type 14 | 1.06E+05 | TCID50/mL | No | No |
| Adenovirus | Type 22 | 2.50E+06 | TCID50/mL | No | No |
| Adenovirus | Type 31 | 1.06E+05 | TCID50/mL | No | No |
| Adenovirus | Type 35 | 4.00E+05 | TCID50/mL | No | No |
| Coronavirus | 229e | 1.26E+05 | TCID50/mL | No | No |
| Coronavirus | NL63 | 1.06E+05 | TCID50/mL | No | No |
| Virus/Bacteria/Parasite | Strain/ID | Concentration | Units | Cross-
Reactivity
(Yes/No) | Interference
(Yes/No) |
| Coronavirus | 0C43 | 1.28E+05 | TCID50/mL | No | No |
| MERS-CoV | None
Specified | 1.04E+05 | TCID50/mL | No | No |
| SARS-Coronavirus | None
Specified | 1.05E+05 | TCID50/mL | Yes | No |
| Cytomegalovirus | None
Specified | 1.13E+05 | TCID50/mL | No | No |
| Enterovirus | Coxsackie | 1.04E+05 | TCID50/mL | No | No |
| Enterovirus | Echovirus | 1.41E+05 | TCID50/mL | No | No |
| Enterovirus | EV68 | 1.28E+05 | TCID50/mL | No | No |
| Epstein Barr Virus | None
Specified | 1.96E+05 | TCID50/mL | No | No |
| Influenza A | HINI | 1.04E+05 | TCID50/mL | No | No |
| Influenza A | pH1N1 | 1.21E+05 | TCID50/mL | No | No |
| Influenza A | H3N2 | 1.05E+05 | TCID50/mL | No | No |
| Influenza B | Victoria | 1.51E+05 | TCID50/mL | No | No |
| Influenza B | Yamagata | 1.06E+05 | TCID50/mL | No | No |
| Measles | None
Specified | 1.04E+05 | TCID50/mL | No | No |
| Human Metapneumovirus | Al | 1.19E+05 | TCID50/mL | No | No |
| Mumps virus | None
Specified | 1.19E+05 | TCID50/mL | No | No |
| Parainfluenza | Type 1 | 1.27E+05 | TCID50/mL | No | No |
| Parainfluenza | Type 2 | 1.26E+05 | TCID50/mL | No | No |
| Parainfluenza | Type 3 | 1.15E+05 | TCID50/mL | No | No |
| Parainfluenza | Type 4 | 1.19E+05 | TCID50/mL | No | No |
| Respiratory Syncytial Virus | Type A | 1.26E+05 | TCID50/mL | No | No |
| Respiratory Syncytial Virus | Type B | 1.14E+05 | TCID50/mL | No | No |
| Human Rhinovirus | Type A | 1.06E+05 | TCID50/mL | No | No |
| Human Rhinovirus | Type B | 1.55E+05 | TCID50/mL | No | No |
| Herpes Simplex Virus | Type 1 | 1.58E+05 | TCID50/mL | No | No |
| Virus/Bacteria/Parasite | Strain/ID | Concentration | Units | Cross-
Reactivity
(Yes/No) | Interference
(Yes/No) |
| Varicella-zoster virus | None
Specified | 1.21E+05 | TCID50/mL | No | No |
| Bordetella pertussis | A639 | 1.00E+06 | CFU/mL | No | No |
| Candida albicans | None
Specified | 1.83E+06 | CFU/mL | No | No |
| Chlamydia pneumoniae | None
Specified | 1.45E+06 | IFU/mL | No | No |
| Corynebacterium sp. | None
Specified | 1.00E+06 | CFU/mL | No | No |
| Escherichia coli | None
Specified | 1.72E+06 | CFU/mL | No | No |
| Haemophilus influenzae | None
Specified | 1.52E+06 | CFU/mL | No | No |
| Lactobacillus sp. | None
Specified | 1.58E+06 | CFU/mL | No | No |
| Legionella pneumophila | None
Specified | 1.00E+06 | CFU/mL | No | No |
| Moraxella catarrhalis | None
Specified | 1.04E+06 | CFU/mL | No | No |
| Mycoplasma pneumoniae | None
Specified | 1.35E+06 | CCU/mL | No | No |
| Neisseria meningitides | None
Specified | 1.68E+06 | CFU/mL | No | No |
| Neisseria sp. | None
Specified | 1.23E+06 | CFU/mL | No | No |
| Pseudomonas aeruginosa | None
Specified | 1.16E+06 | CFU/mL | No | No |
| Pooled human nasal wash -
representative of normal
respiratory microbial flora
(Wet-testing) | None
Specified | N/A | N/A | No | No |
| Staphylococcus aureus | Type Not
Specified | 1.67E+06 | CFU/mL | No | No |
| Staphylococcus epidermidis | None
Specified | 1.53E+06 | CFU/mL | No | No |
| Streptococcus pneumoniae | None
Specified | 1.06E+06 | CFU/mL | No | No |
| Streptococcus pyogenes | None
Specified | 1.07E+06 | CFU/mL | No | No |
| Streptococcus salivarius | None
Specified | 1.05E+06 | CFU/mL | No | No |
| Mycobacterium tuberculosis
avirulent | None
Specified | 1.16E+06 | CFU/mL | No | No |
| Virus/Bacteria/Parasite | Strain/ID | Concentration | Units | Cross-
Reactivity
(Yes/No) | Interference
(Yes/No) |
| Methicillin-resistant
Staphylococcus aureus
(MRSA) | None
Specified | 3.30E+06 | CFU/mL | No | No |
| Methicillin-susceptible
Staphylococcus aureus
(MSSA) | None
Specified | 3.67E+06 | CFU/mL | No | No |

Table 1. Cross-Reactivity/Microbial Interference Study Results

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Image /page/9/Figure/0 description: The image contains the logo for Quidel. The logo features a square with rounded corners, divided into sections of different colors, including red, orange, yellow, green, blue, and purple. Below the square is the word "QUIDEL" in a sans-serif font.

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Image /page/10/Figure/0 description: The image shows the logo for Quidel. The logo consists of a square that is divided into four quadrants, each with a different color. The colors are red, yellow, green, and blue. The word "QUIDEL" is written in a sans-serif font below the square.

11

Image /page/11/Picture/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into smaller triangles of various colors, including red, orange, yellow, green, blue, and purple. The word "QUIDEL" is written in a stylized font below the square, with the "L" extending into a curved line.

Nineteen (19) specimens containing Coronavirus HKU1 were tested with an EUA version of this test (EUA203086) and all resulted as negative.

Interfering Substances

Twenty-four (24) potentially interfering substances were evaluated with the QuickVue COVID-19 Test to verify if endogenous and exogenous substances that may be present in respiratory specimens interfere with the detection of SARS-CoV-2 in the QuickVue COVID-19 Test. Each substance was tested in five (5) replicates in the absence of 6.06E+04 TCIDsylmL of heat-inactivated SARS-CoV-2 (isolate USA-WA1/2020). None of the substances listed in Table 2 interfered with the assay at the levels tested.

Substances	Active Ingredient	Concentration
Throat lozenges, oral anesthetic and
analgesic	Menthol	700 mg/mL
Sore throat spray	Phenol	15% w/v
Mucin
bovine submaxillary gland, type I-S
or pooled mucous	Purified mucin protein	2.5mg/mL
Whole Blood (human)	Whole blood	4% v/v
Leukocytes	Leukocytes	5.00E+06 cells/mL
Zinc (common ingredient in many
nasal sprays)	Zinc	15% v/v
Nasal sprays or drops	Cromolyn, Oxymetazoline	15% v/v
Nasal corticosteroids	Fluticasone	15% v/v
Nasal gel	Luffa opperculata, sulfur,
Sodium Hyaluronate	5% w/v
Homeopathic allergy relief, or nasal
wash	Alkalol	15% v/v
Anti-viral drugs	Molnupiravir (broad-
spectrum antiviral)	2.5 mg/mL
Anti-viral drugs	Oseltamivir Phosphate
(TamiFlu)	2.5 mg/mL
Anti-viral drugs	Ribavirin	2.5 mg/mL
Antibiotic, nasal ointment	Mupirocin	10mg/mL
Hand sanitizer	Isopropyl alcohol	15% v/v
Lotion	Not specified	15% w/v

Table 2. Interfering Substances Study Results

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Image /page/12/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, divided into four quadrants. The top-left quadrant displays a gradient of colors, including yellow, orange, red, and green. The bottom-right quadrant is blue. Below the square is the word "QUIDEL" in a sans-serif font.

Substances	Active Ingredient	Concentration
Hand Soap	Not specified	15% v/v
Rheumatoid Factor	Rheumatoid Factor	1.12 IU/mL
Homeopathic Alkalol	Thymol; Eucalyptol;
Manitol; Camphor;
Benzoin; Potassium Alum;
Potassium Chlorate;
Sodium Bicarbonate;
Sodium Chloride; Oils of:
Sweet Birch; Spearmint;
Pine; Cinnamon	1:10 dilution
Cough syrup (e.g., Robitussin)	Dextromethorphan	5% v/v
Nicotine or Tobacco	Nicotine	0.03 mg/mL
Analgesic ointment (Vicks®
VapoRub®)	Camphor, eucalyptus oil,
menthol	1% w/v
Petroleum Jelly (Vaseline®)	White petroleum	1% w/v
Systemic antibiotic	Tobramycin	4 µg/mL

Hook Effect

To ensure that a high concentration of SARS antigen does not interfere with a positive reaction in the QuickVue COVID-19 Test, a series of five (5) different concentrations of heat-inactivated SARS-CoV2 (isolate WA1/2020) were prepared in NNM and tested in five (5) replicates on the QuickVue COVID-19 Test. The results demonstrated that the QuickVue COVID-19 Test did not display a Hook (Prozone) Effect for any of the levels evaluated from very high to moderate positive inactivated virus concentrations, when tested from 1.09E+06 to 9.09E+04 TCIDsomL (40X to 3X LoD). All spiked samples were 100% positive at all tested concentrations.

Flex Studies

A series of flex studies were performed by testing SARS-CoV-2 negative sample and SARS-CoV-2 positive sample (2XLoD) at various conditions per Table 3 when use-related errors occur. The results demonstrate that the assay does not present a significant risk of an erroneous result when performed by the lay user.

Flex Study	Conditions
Operating Environment Flex	Operating temperature from 5°C to 45°C and relative humidity from
10% to 95%
Extraction Time Flex	Sample swab is placed in reagent tube for time duration from ten (10)
seconds to one (1) hour.
Impact of Different Light Sources Flex	Different light sources including fluorescent, incandescent, and LED
light.
Disturbance During Analysis	Strip is removed from the reagent tube for 30 seconds at 5 minutes of
development time and placed back in tube.
Knock over the reagent tube with strip inside immediately, 1 minute,
and 5 minutes after adding strip in the tube, then immediately place
upright.

Table 3. Flex Studies Conditions

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Image /page/13/Figure/0 description: The image features the logo of QuidelOrtho Corporation. The logo consists of a square divided into two sections. The top section is a gradient of colors, including red, orange, yellow, green, and blue. The bottom section is a solid blue color. Below the square is the word "QUIDEL" in a sans-serif font.

Flex Study	Conditions
Open Pouch Flex	Strip is exposed to ambient air from 1 hour to 2.5 hours.
Development Time Flex	Strip is placed in reagent tube from 5 minutes to 30 minutes.
After 10 minutes development time, strip is removed from the reagent
tube and placed on bench top for 5 minutes before result reading.
Running Steps Out of Order Flex	After sample extraction, leave swab in reagent tube upon insertion of
the test strip into the tube for 30 seconds and 10 minutes.
Swab Agitation Flex	Place the test swab into the liquid inside the reagent tube, and ensure
it is touching the bottom. Do not stir, stir 10 times and stir
continuously for 1 minute.
Place the test swab into the liquid inside the reagent tube, do not
touch the bottom or stir.
Place the test swab into the liquid inside the reagent tube, and ensure
it is touching the bottom. Stir 3-4 times. Do not apply pressure to the
swab head.
Extraction Reagent Disturbance Flex	Shake the closed reagent tube 10 times, 30 seconds vigorously, and
60 seconds vigorously before testing.
Drop the reagent tube 3 times from bench top height before testing.
Sample Temperature Flex	Cold sample is removed from refrigerated condition at 2-8°C and
tested immediately.
Sample Stability	Nasal swab samples were stored at ambient temperature (20-25°C)
and refrigerated (2-8°C) over different lengths of time from 24 hours
to 196 hours to evaluate specimen stability.

Precision

The lot-to-lot precision of the QuickVue COVID-19 Test was evaluated by using three (3) product lots. A series of coded, contrived samples were prepared as negative (1XLoD), and moderate positive (4XLoD) using heat inactivated SARS-CoV-2 (isolate USA-WA1/2020). Each sample was tested in duplicate in two (2) events per day over twenty (20) days with two (2) operators. The negative sample produced results with a lower 95% confidence interval limit ≥95% negative agreement. The low positive sample at 1XLoD produced results with a lower 95% confidence interval limit ≥95% positive agreement.

	Table 4. Summary of Precision Qualitative Results

| Lot | Negative* | | Low Positive**
(1XLoD) | | Moderate Positive**
(4XLoD) | |
|-----------------------|-----------------------------|-----------------------------|-----------------------------|-----------------------------|--------------------------------|-----------------------------|
| | Reader 1 | Reader 2 | Reader 1 | Reader 2 | Reader 1 | Reader 2 |
| 1 | 80/80 | 80/80 | 78/80 | 78/80 | 80/80 | 80/80 |
| 2 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 |
| 3 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 | 80/80 |
| Total | 240/240 | 240/240 | 238/240 | 238/240 | 240/240 | 240/240 |
| %Agreement
(95%CI) | 100%
[98.4% -
100.0%] | 100%
[98.4% -
100.0%] | 99.2%
[97.0% -
99.8%] | 99.2%
[97.0% -
99.8%] | 100%
[98.4% -
100.0%] | 100%
[98.4% -
100.0%] |

Method Comparison

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Image /page/14/Picture/0 description: The image shows the logo for QuidelOrtho Corporation. The logo features a square shape with rounded corners, divided into colorful sections resembling a color wheel. Below the square is the word "QUIDEL" in a simple, sans-serif font.

The performance of the QuickVue COVID-19 Test was compared to a SARS-CoV-2 RT-PCR assay in a prospective clinical study. Eight (8) clinical sites participated in the study. Samples were collected by lay users from themselves or collected for a household member. A total of 878 subjects were enrolled in this study, 39.6% male and 60.4% female. In symptomatic individuals tested within 5 days post symptom onset, the QuickVue COVID-19 Test detected SARS-CoV-2 with Positive Percent Agreement (PPA) of 82.0% and Negative Percent Agreement (NPA) of 99.1% in symptomatic individuals when compared to the result from an EUA extracted SARS-CoV-2 RT-PCR assay. Results are provided in Table 5 and Table 6.

| | SARS-CoV-2 RT-
PCR Assay Result | | | | |
|--------------|------------------------------------|-------|-------|--------------------------------------|--------------------------------------------------|
| | Pos | Neg | Total | | PPA = 82.0% (164/200)
95% CI: 76.1% - 86.7% |
| QuickVue Pos | 164 | રે | 169 | | NPA = 99.1% (575/580)
95% CI: 98.0% - 99.6% |
| QuickVue Neg | 36 | ર્ રજ | 611 | Positivity Rate by 21.7% (169/780) | QuickVue Assay = 95% CI: 18.9% - 24.7% |
| Total | 200 | 580 | 780 | Positivity Rate by 25.6% (200/780) | Comparator Assay = 95% CI: 22.7% - 28.8% |

	Table 5. QuickVue COVID-19 Test Performance Compared to SARS-CoV-2 RT-PCR Assav

PPA= Positive Percentage Agreement; NPA= Negative Percentage Agreement

| Days Since
Symptom Onset | # Specimens
Tested | # Positive
by QuickVue | # Positive
by RT-PCR | PPA |
|-----------------------------|-----------------------|---------------------------|-------------------------|-------|
| 0 | 61 | 14 | 16 | 87.5% |
| 1 | 203 | 45 | 53 | 81.1% |
| 2 | 248 | 52 | 63 | 79.4% |
| 3 | 148 | 27 | 28 | 92.9% |
| 4 | 74 | 21 | 28 | 75.0% |
| 5 | 46 | 10 | 12 | 83.3% |

Table 6. PPA results by DPSO

Conclusion

These studies demonstrated equivalent performance of the QuickVue COVID-19 Test to the predicate product ACON Flowflex COVID-19 Antigen Home Test (K230828).